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Key Sessions

Eliana Clark

Driving value through manufacturing of biological products – Lessons from the past and visions for the future

Biogen Inc., USA

Art Hewig

Next generation drug substance manufacturing technologies

Amgen, USA

Thomas Sauer

Keynote Presentation from BPOG: A Technology Roadmapping process to transform the biopharmaceutical manufacturing industry

Sanofi, Germany

Tyler McQuade

Inspirational Speaker: Battlefield Medicine: "On Demand" Production of What Doctors Need When Patients Need It

Defense Sciences Office, USA

07:30 08:20 (50 mins)

Main agenda

Registration

08:20 08:30 (10 mins)

Main agenda

Chairperson's Opening Remarks

  • Stefanos Grammatikos - VP - Head of Biotech Sciences, UCB Pharma

08:30 09:00 (30 mins)

Main agenda

Driving value through manufacturing of biological products – Lessons from the past and visions for the future

Over the last 30 years, the Biopharma Industry has had remarkable successes and has delivered tremendous value to society through the development of innovative medicines. This presentation will discuss how operations in general and manufacturing in particular has not only enabled this success but has been a major driver of value. We will also outline several possible opportunities for further value creation and will explain Biogen’s hybrid approach to biomanufacturing in that context.

  • Eliana Clark - VP, International Manufacturing Operations, Biogen Inc., USA

09:00 09:30 (30 mins)

Main agenda

Creating capacity: Innovation solutions for the future of bioproduction

  • David Radspinner - General Manger, BioPark, GE Healthcare

09:30 10:00 (30 mins)

Main agenda

Next generation drug substance manufacturing technologies

  • Art Hewig - Director of Drug Substance Process Development, Amgen, USA

10:00 10:30 (30 mins)

Main agenda

Significant technology advances enabling integrated continuous bioprocessing

Continuous manufacturing has been established in several processing industries for many years providing improved economics, quality and flexibility over batch manufacturing operations. Until recently the adoption of continuous approaches in bioprocessing has been limited to perfusion cell culture with downstream processing unit operations and formulation taking place in batch mode with associated capacity limitations and poor facility utilization. With the development of specific enabling continuous technologies, combined with the inherent benefits of single-use approaches, it is possible for the biopharmaceutical industry embrace the continuous manufacturing paradigm and move towards integrated end to end continuous bioprocessing, resulting in a more efficient, agile and truly global production of biotherapeutics. Presentation will discuss a range of continuous process-enabling technologies aimed at the key unit operations within the production of monoclonal antibodies and other recombinant proteins.

  • Martin Smith - Chief Technology Officer, PALL Life Sciences

08:25 08:30 (5 mins)

Cell Line Development and Engineering

Chairperson's Opening Remarks

  • Simon Fischer - Global Bioprocess + Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG

08:30 09:00 (30 mins)

Cell Line Development and Engineering

Patent and IP aspects of CRISPR – the main challenge of CRISPR

  • What is the patent issue - Is the technique free to use?
  • Is a commercial license necessary?
  • Has the actual technology moved on? 
  • When companies pay for commercialisation then get a license to the person who has the right-  who will own that right?
  • If used in a product they want to sell, then they need permission but is it ok for research?
  • IP isn’t clear- so didn’t use it for anything other than research purposes
  • Fabien Palazzoli - Life Sciences IP Analyst, Principal consultant, Life Sciences and Biotechnology, IPStudies

09:00 09:30 (30 mins)

Cell Line Development and Engineering

CRISPR-mediated genome engineering tools towards improved CHO cell factories

  • Latest development of efficient genome engineering technologies
  • Multiplexed genome engineering
  • Helene Faustrup Kildegaard - Co-Principal Investigator, Technical University of Denmark

09:30 10:00 (30 mins)

Cell Line Development and Engineering

Evaluation of siRNA technology as a bioprocessing tool to improve productivity and product quality challenges in CHO

  • Case study utilizing siRNAs for silencing of LDHa, B1,4 galactosyl transferase, and Cathepsin D protease
  • highly potent siRNAs can be manufactured with high specificity to target gene
  • siRNA approach is potentially faster than KO approach for late stage development and would not require a cell line change
  • siRNA approach to gene silencing is titratable allowing dialing in the desired phenotype
  • costs associated with utilizing siRNAs are feasible for commercial manufacturing
  • Rodney Combs - Associate Research Fellow, Bioprocess R&D, Culture Process Development World Wide Pharmaceutical Sciences, , Pfizer

10:00 10:30 (30 mins)

Cell Line Development and Engineering

The latest research findings on engineering cell lines by using MicroRNAs

  • miRNAs represent promising tools for cell engineering of biopharmaceutical production cells
  • Identification of numerous effective miRNAs to optimize CHO-production cells
  • Novel data on engineering of CAP®-production cells using miRNAs
  • Mechanisms of action within cells can be revealed
  • Easy-to-use methodology makes miRNAs feasible for usage in production process
  • Kerstin Otte - Pharmaceutical Biotechnology (PBT), Institut of Applied Biotechnology (IAB), Biberach University of Applied Sciences

10:30 11:15 (45 mins)

Main agenda

Morning Coffee

11:13 11:15 (2 mins)

Vaccine Manufacturing

Chairperson's Opening Remarks

  • Dan Adams - Executive Chairman and Global Head of Business Development, Protein Sciences Corporation, USA

11:13 11:15 (2 mins)

Process Development and Characterisation Strategies

Chairperson's Opening Remarks

  • Shekar Ganesa - Executive Director, Process Development, Amgen Inc., USA

11:13 11:15 (2 mins)

Bioprocess Analytics and Control Strategies

Chairperson's Opening Remarks

  • Parag Shah - Senior Engineer and Group Leader, Roche/Genentech, USA

11:13 11:15 (2 mins)

Viral Safety for Biologics

Chairperson's Opening Remarks

  • Maria Farcet - Scientist, Global Pathogen Safety, Shire, Austria

11:13 11:15 (2 mins)

Downstream Processing

Chairperson's Opening Remarks

  • Michel Eppink - Director Downstream Processing, Synthon Biopharmaceuticals BV, The Netherlands

11:13 11:15 (2 mins)

Upstream Processing

Chairperson's Opening Remarks

  • Willie Hesselink - R&D Manager Pharmaceuticals/LifeSciences, Avantor Performance Materials

11:15 11:45 (30 mins)

Cell Line Development and Engineering

Keynote: CHO cells - genes, chromosomes and genomes, processes and products: From early origins to a maturing industry

  • Emergence, genetics, phenotypes and use of industrially relevant CHO cells
  • Regulatory: strengths and constraints, cloning, “animal component free”, CDM, QbD, etc.
  • From steel to plastic and back in large scale manufacturing
  • High density cultures - continuous or not
  • Future manufacturing with alternative to stable, clonally derived cell populations
  • Professor Florian M. Wurm - Professor Emeritus, Swiss Federal Institute of Technology Lausanne (EPFL)

11:15 11:35 (20 mins)

Viral Safety for Biologics

Strategies For Minimizing Adventitious Virus Risk

The use of Next Generation Sequencing (NGS) to assess genetic stability of cell banks has the potential to accelerate this regulatory required test, and provide a much richer data set than traditional methods.  We will present an overview of the challenges of establishing a GMP-compliant NGS work stream.  We will also discuss how decentralized computational power – the Cloud - is leveraged to provide full scalability, as well as associated data security concerns.

  • Alison Armstrong - Senior Director, Global Head of Field Development Services, Merck BioReliance® Services, UK

11:15 11:45 (30 mins)

Vaccine Manufacturing

Challenges in the vaccines industry – what is currently impacting the market?

  • Vaccine hesitancy
  • Adverse events associated with pandemic vaccines
  • What vaccines are more/less prevalent and why?
  • Emerging diseases and what gaps lie in the current market?
  • Main target populations – geriatric vs. paediatric vs. maternal
  • Nicholas Jackson - VP, Global Head of Research, Sanofi Pasteur, France

11:15 11:45 (30 mins)

Upstream Processing

Process to product quality relationship

In this study, we use definitive screening design (DSD) methodology to effectively assess the combinatorial impacts of media supplements on monoclonal antibody production and glycan product quality.  We evaluated and identified several media supplements to modulate the n-glycan distributions.  Combining these supplements and further cell culture process optimization, we were able to achieve higher titers while obtaining desirable n-glycan profile. These findings helped us in developing a tool box for controlling product quality and a better understanding of the relationship between processes and product quality.

  • Swapnil Bhargava - Director, BioProcess Development , Seattle Genetics, USA

11:15 11:45 (30 mins)

Downstream Processing

Possibilities for integrated continuous downstream process

The aim of the talk is to present current status and updates within nextBioPharmDSP project - Next-generation biopharmaceutical downstream process, where the main focus is to develop continuous and integrated process for purification of monoclonal antibodies. The specific topics, on which the focus will be on are different approaches for primary separation, such as flocculation or ATF/TFF in perfusion, continuous chromatography, several flow-through options for polishing steps and advanced analytical tools, which will enable in-line detection of quality.

  • Helena Trnovec - Scientist, Lek Pharmaceuticals (a Novartis company), Slovenia

11:15 11:45 (30 mins)

Process Development and Characterisation Strategies

Keynote Presentation from BPOG: A Technology Roadmapping process to transform the biopharmaceutical manufacturing industry

The complexity of the current industry structure has held back innovation, with many biomanufacturers trying to develop new technology in isolation, whilst supply partners have to often guess common industry requirements. Over the last two years, BioPhorum Operations Group’s (BPOG’s) technology roadmapping collaboration has brought together 26 of the biopharmaceutical industry’s top companies, along with leading academics, to establish an industry technology strategy. The first publication of the roadmap will be just the beginning, like every strategy it will be refreshed and updated regularly, also facilitating and tracking the industry’s progress towards future vision.

  • Thomas Sauer - VP Product Development Management Biologics and Member of BPOG Technology Roadmap Group, Sanofi, Germany

11:15 11:45 (30 mins)

Bioprocess Analytics and Control Strategies

Advanced process control in biologics drug substance manufacturing

Biogen’s next-generation biologics drug substance manufacturing processes utilise predictive models, real time release testing with feedback and feed forward controls that enable us to predict and assure product quality. This presentation will provide an overview of our next generation manufacturing processes based on advanced process control (APC) and the APC enabling technologies being implemented

  • Eliana Clark - VP, International Manufacturing Operations, Biogen Inc., USA

11:35 11:55 (20 mins)

Viral Safety for Biologics

Investigational study on the robustness of the 20nm nanofiltration step performed according to the DoE methodology

The manufacturing processes of plasma derived medicinal products (PDMP) include several steps for removing/ inactivating pathogens. Among them, the nanofiltration (a dedicated step) is noteworthy for its effectiveness with respect to small non-enveloped viruses such as HAV and B19V. However efficient removal of small viruses from high molecular weight protein solutions such as IgG and some clogging factors remains challenging. To ensure both virus removal and protein yield, we describe a DoE methodology on a 20-20 nm nanofiltration step for a plasma product to 1) identify optimal nanofiltration conditions for protein yield and 2) define the design space for PPV removal. Using this method we could confirm that PPV removal was effective within the manufacturing operating conditions and obtain robustness data beyond the normal operating conditions ranges.

  • Celine Ducloux - Biological Safety Studies Manager, LFB Biotechnologies, France

11:45 12:15 (30 mins)

Vaccine Manufacturing

Economics of vaccines and future investments

  • Feedback on the future of vaccines
  • Where will investments be made?
  • Economics of vaccine investment
  • Where does the most potential lie?
  • Ensuring ROI
  • Martin Mengel - Program Leader, Enteric Diseases Project Coordinator – Africhol, AMP, France

11:45 12:15 (30 mins)

Upstream Processing

Evaluation of nutrient requirements in two CHO cell lines

The effect of residual nutrient concentration on cell growth, viability and recombinant protein production was evaluated in two CHO K1 cell lines grown in perfusion and fed batch. The perfusion rate was varied to achieve different nutrient levels, while bolus feeds were used in fed batch culture. The effects of excess nutrients and nutrient limitation on metabolic rates, LDH release, and productivity of the cultures were evaluated.


  • Monica Ambrose - MSAT Cell Culture Scientist, BioMarin Pharmaceutical Inc. Ireland

11:45 12:15 (30 mins)

Downstream Processing

Development of next generation downstream processing techniques to optimise DSP

The presentation will cover the application of new technologies to optimise the performance of a range of DSP unit operations by way of overcoming existing challenges, or creating new operational options. The development of these downstream processing techniques will be described at the development lab scale. Consideration of the when the technologies can be implemented within the product lifecycle will be presented alongside an assessment of the advantages and disadvantages. Finally, factors impacting the implementation of the technologies at manufacturing relevant scales for GxP manufacture will be discussed.

  • Andrew Brown - Associate Director, Process Sciences, Allergan Biologics, UK

11:45 12:15 (30 mins)

Process Development and Characterisation Strategies

BPOG’s 5-year vision plan for disposable technology

The uptake of disposables in GMP bio-manufacturing has been gaining momentum for over the last 5 years. To fully incorporate such disruptive technology into commercial operation, it is necessary for bio-manufacturers along with suppliers and regulators to develop and layout a cohesive plan to move realise the full benefit of disposables. During this talk, a 5-yr vision plan developed by BPOG members will be presented.

  • Ken Wong - Deputy Director Department: Process Technology , Sanofi, USA

11:45 12:15 (30 mins)

Bioprocess Analytics and Control Strategies

Process analytics update: On-line process monitoring and control in product and process development and production

  • Product, process and PAT variability - The impact on product quality and costs   
  • Challenges facing process analytical technologies in product and process development and production
  • Calibration maintenance and transfer - Are your calibration models fit-for-purpose? 
  • Is there a place for software sensors in bio-processing?
  • Ornella Preisner - Senior QdD Scientist, UK National Biologics Centre

11:45 12:15 (30 mins)

Cell Line Development and Engineering

Update on adventitious agents

  • Safety of cells used for manufacturing- engineered cells
  • How to demonstrate the absence of adventitious agents?
  • If cell lines have additional concerns on host original, then consider additional assays to ensure safety from viral agents
  • New methods in NGS- how can they help to address the added concerns
  • Arifa Khan - Senior Investigator, FDA/CBER

12:15 12:45 (30 mins)

Viral Safety for Biologics

Fully single-use for virus filtration in manufacturing - New concepts and strategies

Current bio manufacturing processes have reached a high degree of standardization and companies are working on the basis of proven technology platforms. Single-use technology has become a viable option for clinical as well as commercial manufacturing. To reduce time to market multipurpose facilities with fully single-use technologies are used which provides highest flexibility to bring the products fast into the market. Investment costs are much lower and in addition also safety aspects are considered in a much better way. These are just some advantages of fully single-use processes.

One application were single-use is of strong interest is the current trend into continuous manufacturing processes. These two developments, into fully single-use as well as continuous manufacturing, bring new challenges to the industry and the different operation units. Gamma sterilisation replaces SIP cycles; tubing instead of stainless steel piping even at high pressures or peristaltic pumps as driving sources replaces classical pressure overlays.

This presentation will focus in concepts for creating single-use virus filtrations steps in different manufacturing ways. Hybrid solutions up to fully single-use process set ups for batch as well as continuous manufacturing. Bioburden reduced processes vers fully sterile operation requirements. Ready to use, plug and play units make life easier for the manufacturing people but need to be taken into consideration already during development of a virus filtration step. Differences in operation e.g. different operating pressures or low flux rates are looked into and the effect onto the retention capabilities of commercially available virus filters is evaluated.

  • Birte Kleindienst - Junior Product Manager, Virus Clearance, Sartorius Stedim Biotech GmbH

12:15 12:45 (30 mins)

Vaccine Manufacturing

Discussion panel: The future of vaccines

  • What are the emerging vaccines
  • Where are the biggest investments being made
  • How is the market changing to meet the needs of patients/the population globally
  • Outlook on the future of the industry
  • Martin Mengel - Program Leader, Enteric Diseases Project Coordinator – Africhol, AMP, France
  • Nicholas Jackson - VP, Global Head of Research, Sanofi Pasteur, France

12:15 12:45 (30 mins)

Cell Line Development and Engineering

Accelerating protein and therapeutic development with transient and stable cells

  • The benefits of transient protein expression that can scale to meet increased demands
  • When to use transient and stable cell lines for different protein requirements
  • Advances in protein engineering using whole genome screens, mammalian libraries, CAR-T cells, and gene editing
  • Erik Jans - Europe Business Development Manager, MaxCyte

12:15 12:45 (30 mins)

Downstream Processing

Innovative hydrophobic interaction chromatography (HIC) resins for next generation molecule challenges

Abstract:

Advances in biotherapeutics are generating a wider range of biomolecules that are presenting unique and often difficult separation and purification challenges. Based on the complex needs of the industry a series of HIC prototypes were developed over a range of hydrophobicity. Utilizing extensive user input, design goals focused on development of resins with market leading resolution and capacity, as well as optimized surface and flow characteristics for increased throughput and high product recovery. All of which are typical pain points for current HIC separations. An additional goal was maintenance of resin performance at lower salt concentrations or with weaker kosmotropic salts. A new POROS base bead was designed for high performance in both bind/elute and flow-through HIC applications of a wide variety of biomolecules and sizes. A novel coating procedure was developed along with functionalization with a unique aromatic ligand to provide a wide range of hydrophobicity. This range of resins both span and extend the hydrophobicity of commercially available products, while still maintaining design criteria. With increased performance in capacity and resolution these resins are differentiated especially when considering the range of characteristics and hydrophobicity of target biotherapeutics. These prototype resins are suitable for both bind and elute as well as flow-through applications and have excellent resolution, high capacity, and fast flow rate capability when compared to other HIC chemistries. This poster will highlight the benefits of a high performing HIC resin and the need for a range of hydrophobicity as a solution for a wide range of applications and challenging molecules.

Talk abstract:

Based on the complex purification needs a series of POROS™ HIC resin prototypes were developed over a range of hydrophobicity. This presentation will highlight the benefits of a high performing HIC resin as a solution for a wide range of applications.

  • Shelly Parra - Senior Manager, Global Field Applications, Thermo Fisher Scientific, Inc.

12:15 12:45 (30 mins)

Process Development and Characterisation Strategies

A strategy for enhanced assurance of supply, quality and change control of single-use systems

Key objectives:

The presentation provides an overview of the emerging challenges associated with the increasing adoption of single-use systems in bio-manufacturing and outlines a supply chain and quality strategy where raw material specifications and process controls achieve robust assurance of supply and product quality.

Abstract

With the adoption of single-use solutions in all process steps of commercial production, suppliers of single-use become an integrated part of the bio-manufacturing process and there is a significantly increased reliance on their supply chain and quality systems. Suppliers are expected to better characterize their raw materials, control the variability, understand the impact on product quality and continuously improve their quality systems.

The presentation introduces a new integrated supply chain and quality by design strategy whereby single-use systems integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations provide better knowledge, specifications and controls of the entire manufacturing process from the resins, the additives and the films to the final single-use solution.

The presentation outlines how establishing resin specifications, film extrusion design spaces, quality agreements and supply contracts can significantly reduce raw material variability, strengthen change control and provide consistent film quality attributes.

The author will explain how the control of the entire supply chain and manufacturing process from the resins to the final product, material safety stocks, back-up equipment and dynamic manufacturing network expansion ensure long term business continuity.

Audience take-home messages:

  • Control of the entire process from the resins to final products enhances assurance of supply
  • Resin specification and control reduces raw material variability and improves change control
  • Film design space and control of the entire process provide consistent product quality
  • Safety stocks and manufacturing network expansion ensure business  continuity
  • Jean-Marc Cappia - Group Vice President Marketing & Product Management, Fluid Management Technology, Sartorius Stedim Biotech, France

12:15 12:45 (30 mins)

Bioprocess Analytics and Control Strategies

Leveraging the ‘Voice of the Process’ to drive risk-based process improvements

Ensuring reliable supply of quality medicines to patients is Roche’s priority. Assessing capabilities of manufacturing processes to produce lots conforming to release specifications is key. Early risk identification via process monitoring and risk-based prioritisation using a unique statistical approach enhances understanding and drives timely continuous improvement. Furthermore, industry benchmarking has enabled us to converge toward a common interpretation of CPV.

  • Parag Shah - Senior Engineer and Group Leader, Roche/Genentech, USA

12:15 12:45 (30 mins)

Upstream Processing

Overcoming buffer preparation and operation bottlenecks

  • Cecilia Annerén - Global Marketing Manager, BioProcess, GE Healthcare, Sweden

12:45 14:00 (75 mins)

Main agenda

Lunch in the Exhibition Hall

13:10 14:00 (50 mins)

Main agenda

Live Lab Tour- Insight into some of the most innovative technoloiges to hit today’s biopharmaceutical market on show in the exhibition hall

Companies participating in the Live Lab Tour include:

  • Gyros 
  • Thermofisher 
  • Nova Biomedical 
  • GE 
  • Sartorious

13:15 14:00 (45 mins)

Main agenda

Roundtable Discussion: BPOG Technology Roadmap

  • Thomas Sauer - VP Product Development Management Biologics and Member of BPOG Technology Roadmap Group, Sanofi, Germany

13:58 14:00 (2 mins)

Upstream Processing

Chairperson's Opening Remarks

  • Swapnil Bhargava - Director, BioProcess Development , Seattle Genetics, USA

14:00 14:30 (30 mins)

Viral Safety for Biologics

Virus removal capacity in the downstream process of new format antibodies

  • Moritz Bennecke - Manager Development Recovery & DSP, Roche Diagnostics, Germany

14:00 14:30 (30 mins)

Vaccine Manufacturing

Assessment of active specific immunotherapy that may provide a pathway to immunoprevention of adenocarcinomas

  • In spite of the degree of recognized heterogeneity of cancer, attention is still devoted to a problematic homogeneous, targeted approach to Immunotherapy.
  • With all due respect to the current use of Check Point inhibitors, it is illogical to wait for recurrence and progression of disease to treat cancer.
  • Our 30 years of perspective of patient specific active immunotherapy in the adjuvant setting, convinces us that amplifying the patients immune response will benefit the clinical outcome by destroying occult disease, prevent recurrence in the majority of patients and stave off immunosuppression.
  • This programmed approach to immunotherapy will benefit the majority of patients.
  • We also discovered and learned some key fundamental principles of cancer biology and host tumor interactions that have opened a pathway to developing a neoantigen vaccine that may be effective in preventing all adenocarcinoma formation or progression
  • Michael G. Hanna Jr. - Founder and Chairman Emeritus, Vaccinogen Inc. USA

14:00 14:30 (30 mins)

Upstream Processing

Optimising cell culture media to reduce the reliance on animal sourced material

  • Marie Murphy - Microbiologist, Biotechnology Operations , Eli Lilly and Company, Ireland

14:00 14:30 (30 mins)

Downstream Processing

Optimisation of a mixed-mode chromatography step for aggregate removal and viral clearance

Strategies and preliminary results will be presented regarding the optimisation of a mixed-mode chromatography step. The original method has been proven to be very potent in aggregate removal from various mAb preparations in different scales, but the method needed to be optimised to provide satisfactory viral clearance for clinical development supply.

  • Karin Felderer - Associate Director, Protein Sciences & CMC, MorphoSys AG, Germany

14:00 14:30 (30 mins)

Process Development and Characterisation Strategies

Please move to another stream

14:00 14:30 (30 mins)

Bioprocess Analytics and Control Strategies

PAT strategy and application to bioprocess development for process understanding and control

Process Analytical Technology can rapidly provide enhanced knowledge of raw materials, manufacturing parameters and their linkage to key performance indicators (KPI) and product quality attributes (PQA). We will present experiences in applying PAT during process development, where opportunities exist for better process understanding & control that enable development of a highly robust manufacturing process with an assurance of final product quality.

  • Hong Li - Process Development and Engineering, MRL, Merck & Co., Inc., USA.

14:00 14:30 (30 mins)

Cell Line Development and Engineering

A host cell protein that may impact polysorbate degradation

There is great interest in a better understanding of difficult to remove host cell proteins. We used a proteomics approach to identify different classes of difficult to remove CHO host cell proteins. One of the proteins that was identified may play a role in polysorbate degradation. We evaluated cell line development strategies to mitigate the expression of this protein and any resulting impact on polysorbate degradation.

  • Professor Kelvin Lee - Professor of Chemical & Biomolecular Engineering, University of Delaware

14:30 15:00 (30 mins)

Viral Safety for Biologics

Poster session: Virus inactivation and removal case studies

  1. Viral clearance by resin reuse
  2. High throughput and high parvovirus retention filters
  3. Virus clearance supporting QbD findings
  4. Virus clearance by purification process for non-MAbs
  5. Virus removal by mixed mode chromatography
  6. Low pH virus inactivation
  7. Alternatives to Detergents for Viral Inactivation - Implications of EU Annex XIV – Confirmed speaker: Marie Murphy, Microbiologist, Biotechnology Operations at Eli Lilly and Company, Ireland
  8. Mouse parvovirus and recombinant proteins: how cell-based and molecular assays address the issue - Confirmed speaker: Maria Farcet, Scientist, Shire, Austria
  • Marie Murphy - Microbiologist, Biotechnology Operations , Eli Lilly and Company, Ireland
  • Maria Farcet - Scientist, Global Pathogen Safety, Shire, Austria

14:30 15:00 (30 mins)

Upstream Processing

Cascading effects in bioprocessing: The impact of upstream conditions on cell health, host cell protein profile and clearance

This presentation will take place in Room E105-E106

  • Upstream conditions affect cell health, HCP concentration and composition
  • Cell viability and HCP concentration at harvest are not the best determinants of ease of mAb purification
  • High percentage of intracellular proteins in HCP mixtures points to secretion being a major factor in accumulation in supernatant
  • HCPs that co-elute with mAb after protein A purification are different depending on upstream conditions
  • Persistent HCPs include species with predicted high immunogenity and others with proteolytic activity
  • Dr Cleo Kontoravdi - Senior Lecturer, , Imperial College London

14:30 15:00 (30 mins)

Downstream Processing

Purification process development of biotherapeutic proteins

Purification process development has become a more structure based approach by using high throughput screening technologies and statistical design. A large variety of conditions at microscale format can be tested resulting in more robust purification processes for biologicals with low product amounts. One of the challenges in these smart developments concerns the translation of purification processes from microtiter plates towards labscale format in columns. In this presentation some case studies will be explained.

  • Michel Eppink - Director Downstream Processing, Synthon Biopharmaceuticals BV, The Netherlands

14:30 15:00 (30 mins)

Process Development and Characterisation Strategies

An integrated “Patient Centric” approach to the development and control of biologics

The development of a commercial product manufactured according to the Quality Target Product Profile (QTPP) will ensure that it will meet its desired Target product profile (TPP) (i.e. quality, in vivo safety and efficacy). In this presentation we will share our progress on an integrated product development paradigm that starts with a well-defined TPP and QTPP to implement attribute control strategies.

  • Shekar Ganesa - Executive Director, Process Development, Amgen Inc., USA

14:30 15:00 (30 mins)

Bioprocess Analytics and Control Strategies

Using an LC-MS/MS multi-attribute method for process characterisation

Complex biologics provide a unique analytical challenge for characterising and monitoring CQAs. We developed an LC/MS based approach that reduces analytical testing time and allows for more comprehensive and timely support of process characterisation and development. Here we present a case study of how this method has increased our understanding of the impact of process parameters on product quality.

  • Kristin Krukenberg - Analytical Product Owner, Shire, USA

14:30 15:00 (30 mins)

Cell Line Development and Engineering

Cascading effects in bioprocessing: The impact of upstream conditions on cell health, host cell protein profile and clearance

  • Upstream conditions affect cell health, HCP concentration and composition
  • Cell viability and HCP concentration at harvest are not the best determinants of ease of mAb purification
  • High percentage of intracellular proteins in HCP mixtures points to secretion being a major factor in accumulation in supernatant
  • HCPs that co-elute with mAb after protein A purification are different depending on upstream conditions
  • Persistent HCPs include species with predicted high immunogenity and others with proteolytic activity
  • Dr Cleo Kontoravdi - Senior Lecturer, , Imperial College London

14:30 15:00 (30 mins)

Vaccine Manufacturing

Oral Recombinant Vaccines

  • Emery Dora - Associate Director, Business Development, Vaxart, Inc, USA

15:00 15:30 (30 mins)

Viral Safety for Biologics

Biosafety Testing: Approaches to biosafety testing of viral vectors and vaccines

Regulatory authorities such as the US Food & Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) impose stringent limits on the amount of microbial contaminates and impurities present during the manufacturing of biological medicines, including viral vaccines. These regulations ensure sterile products and thus patient safety. To establish that the testing procedures are accurate, regulatory authorities require proof of testing before clinical trials can be approved or a batch of commercial biopharmaceuticals or viral vaccines be released. Consequently, all components of the manufacturing process must undergo extensive safety testing to demonstrate identity, stability, and purity

  • Richard Adair - Virology and Technical Support Manager, SGS Virology

15:00 15:30 (30 mins)

Vaccine Manufacturing

Characterization of Gene therapy vectors, VLPs and whole viruses from pre-formulation through process development to final manufacturing.

MiniTEM™ is a low-voltage electron microscope designed for automated nanoparticle characterization of negatively stained samples. Accurate comparative metrics and high quality images that reveal purity or particle integrity can easily be obtained at different formulations or purification steps. In addition, for filled versus empty analysis of gene therapy vectors an objective method has been proven based on cryo-TEM semi-automated imaging analysis.

  • Josefina Nilsson - Head of EM services , Vironova, Sweden

15:00 15:30 (30 mins)

Upstream Processing

Cell culture optimised poloxamer 188 with improved shear protection

Poloxamers 188 is an amphiphilic nonionic polymer used in cell culture media to protect mammalian cells from shear stress caused by sparging. Performance variations between lots have been reported. To identify the root cause of this lot-to-lot variability we have investigated the performance of more than 100 different Poloxamer 188 lots. Based on our findings we have developed a new Poloxamer 188 grade of very high purity that is optimized for the use in cell culture processes and reliably protects cells from shear stress.

  • Almut Rapp, Merck KGaA , Germany

15:00 15:30 (30 mins)

Downstream Processing

Scalability of Planova™ BioEX processes

Correspondence between small-scale filtration data and manufacturing-scale filter performance is absolutely critical to be able to predict manufacturing process performance from process development experiments and for the validity of small-scale viral clearance validation studies. The scalability of Planova filters has been demonstrated previously using several performance metrics. and direct evaluation of virus removal capabilities on all sizes has been evaluated for Planova 15N and 20N filters. In this study on Planova BioEX filters. hollow fibers from three spinning series were manufactured into filters having effective surface area ranging from 0.0003 to 4.0 m2• The filters were evaluated for viral clearance capability using PP7 bacteriophage as a model for small virus contaminants. Robust viral clearance was consistently observed across all Planova BioEX filter sizes with complete clearance and PP7 logarithmic reduction values (LRV) exceeding 4 log10 for all filtrations. These results demonstrate the excellent scalability of Planova BioEX filters. showing scalable filtration throughput and consistent virus removal capacity across all sizes. These findings support the application of small-scale viral clearance studies to validate virus filtration processes at larger scales.

  • Roya Dayani - Product Manager, Asahi Kasei Bioprocess Europe

15:00 15:30 (30 mins)

Process Development and Characterisation Strategies

Case Study: PC of a purification process

· A process characterization strategy using a QbD approach

· Implementing a quality system in R&D to accompany process characterization

· Overcoming technical challenges encountered in scale-down model development in both upstream and downstream PD

· Risk-assessment driven plan for future DoE activities

  • Kelley Dowd - Process Development Scientist, Cytovance Biologics

15:00 15:30 (30 mins)

Cell Line Development and Engineering

Benefits and advances of a platform technology for future challenges in cell line development

The market for therapeutic proteins is steadily growing, resulting in an increased demand for fast and efficient cell line and process development platforms. Additionally, new challenges arise with increasing complexity of novel biological formats as well as with the strict requirements for biosimilars regarding quality and productivity.

The Cellca CHO expression platform comprises a potent vector system and a highly productive host cell line combined with tailored chemically-defined media and upstream process design.

The expression system is suitable for high-titer production of monoclonal antibodies as well as for complex molecules such as bispecific antibodies and Fc fusion proteins. The fed-batch performance of the technology is directly transferable from small scale systems (ambrTM15, ambrTM250) to large scale bioreactors without the need for media and process optimization. However, for sophisticated products such as biosimilars, individual media and process modifications as well as genetic engineering approaches can be used to achieve targeted protein quality. Moreover, Sartorius Stedim Cellca’s single cell cloning process combined with a microscopic imaging system provides a well-documented record of cell monoclonality that is in line with regulatory requirements. The vast majority of production clones show stability over a time period covering the whole subsequent cell banking and production process, which is verified by a new optimized stability study design.

Recent developments resulted in further improvements of the Cellca CHO expression platform: an optimized cell line development approach reduces the timeline by one months and shows increased product titers especially for difficult-to-express molecules. Moreover, several improvements of the expression vector showed the potential to significantly increase the overall productivity of the technology.

The described characteristics make the Cellca CHO expression platform the first choice for large-scale manufacturing of biopharmaceuticals as well as for future bioprocessing challenges.

  • Cornelia Lindner - Team Leader Operations, Sartorius Stedim Cellca GmbH

15:00 15:30 (30 mins)

Bioprocess Analytics and Control Strategies

Implementation of PAT-enabled process control for bioprocess optimisation

This presentation will address approaches to the implementation of PAT-enabled control strategies for bioreactor control and optimisation. Challenges include the integration of data handling, process modelling, and real-time feedback control to deliver improved process performance through the application of advanced model predictive control to cell culture processes.

  • Professor Brian Glennon - CTO, APC Ltd, Ireland

15:30 16:00 (30 mins)

Main agenda

Afternoon Coffee and Poster Viewing

15:55 16:15 (20 mins)

Cell Line Development and Engineering

Spotlight Presentation- A novel integrated end-to-end workflow system supporting high throughput cell line and scale-down upstream process screening

 We have implemented a dedicated end-to-end platform to support the whole bioprocess development workflow from cell line development, via upstream and downstream development, to analytical development. Co-developed in close collaboration with leading biopharmaceutical companies, the platform fully automates the cell line and upstream process assessment, which increases process efficiency and quality. It supports the full workflow including seeding, selection, passaging, analyzing, cryo-conservation and processing in bioreactors, including micro-bioreactors such as ambrR. The system tracks the full history of all clones - from initial transfection all the way to their evaluation in bioreactor runs - and combines this information with product quality and analytics data. It directly integrates with all instruments, such as pipetting robots, colony pickers, bioreactors and bioanalyzers. It can be applied to both antibodies (IgGs, novel formats) as well as therapeutic proteins (e.g., engineered FVIII variants, fusion proteins). Here, we present concrete use cases to demonstrate how the platform supports the automation of the development and assessment of mammalian cell lines and related upstream processes in high throughput, which shortens timelines and significantly reduces costs.  

  • Dr. Christoph Freiberg - Senior Scientific Consultant, Biologics, Genedata

16:00 16:15 (15 mins)

Viral Safety for Biologics

Spotlight Presentation - NGS and detection strategies for viral contamination

This slot is reserved for technology and service providers; please contact luke.pickering@knect365.com for more info.

16:00 16:15 (15 mins)

Vaccine Manufacturing

Viral vaccine manufacturing: Improved Process Development Strategies

Currently over a thousand vaccines are in development worldwide and although the classification can be different, these are often targeting the same disease indication. While there is no one-fits-all solution for these complex products, using a ‘platform approach’ for development in an early stage creates benefits in terms of time-to-market, Cost-of-Goods, risk mitigation and flexibility. Choosing the right partner in terms of process solutions and supply chain and making use of scalable and flexible technologies will help in increasing the chance of success.

The presentation will discuss the platform approach from Sartorius Stedim Biotech for the manufacturing of viral vaccines. It will show how the technological developments help to set-up a robust and scalable process using single use technologies. Next to this the theory is put to reality in a case study showing how process optimization on small scale can help designing the scale-up and demonstrating the benefits of using a platform approach for process development.

  • Kai Touw - Process Development Consultant,, Sartorius Stedim Biotech, The Netherlands

16:00 16:15 (15 mins)

Upstream Processing

Cyto-Mine® – An enabling platform for biologic discovery and development

Picodroplet technology can be used to rapidly screen, identify and isolate rare and valuable variants within large heterogeneous cell populations. We are launching the Cyto-Mine® Single Cell Analysis and Monoclonality Assurance System, a new industrially robust system which leverages this cutting-edge approach for the discovery, development and characterization of novel biotherapeutics. It will deliver dramatic time, cost and labor savings and integrate into established workflows.

  • Frank Craig - Chief Executive Officer, Sphere Fluidics Limited

16:00 16:15 (15 mins)

Downstream Processing

Making connections

Single-use flow paths and assemblies are now the accepted solution within the biopharm industry with standardisation being achieved using known, characterised components. However, systems are only as robust as their weakest link - typically any connection or seal between components, which are often made with the same method that has always been used with little further rationale. By looking at sealing mechanisms and test data collected for common connections under controlled conditions, the advantages and disadvantages of different methods will be discussed.

  • Graeme Proctor - Product Manager (Single-Use Technologies), Parker domnick hunter

16:00 16:15 (15 mins)

Process Development and Characterisation Strategies

Smarter pharma – In action

Fast data, streaming data, IoT data, Industry 4.0 data, factory data, big data, all data. As new and exciting sources of data become available, primarily driven by IoT and connected devices, new methods of analysing data are required. But making a start can be both confusing and daunting. The good news is you don’t have to be a data expert to be compliant, drive GMP or improve quality and increase yield - predictive analytics tools should do that for you. Come and hear a real life example of how one of the largest biopharmaceutical companies in the world did just that.

  • Nuno Antonio - Senior Manager Sales Engineering, Statistica

16:00 16:15 (15 mins)

Bioprocess Analytics and Control Strategies

A fearless approach to continuous manufacturing

Key Messages:

  • Challenges implementing CM require deep process understanding at unit op level
  • Material tracking/data alignment/segregation strategy – all have to mesh
  • PAT data can be leveraged for IPC & RTRT strategies
  • Full support of internal stakeholders is critical

Abstract:

Three focus areas will be highlighted which illustrate Vertex’s approach to Continuous Manufacturing (CM). Data-driven process development techniques were utilised to optimise a twin-screw wet granulation formulation on a commercial scale CM production rig. Strategic employment of an array of PAT systems enabled data acquisition for both in-process and real-time-release measurements. In addition, a robust segregation strategy was developed using material tracking information generated by Residence Time Distribution (RTD) studies conducted on the system. These investigations (and others), enabled a comprehensive production and release strategy to be developed for the first fully continuous drug product manufacturing system in our industry.

  • Gregory Connelly - Associate Director, Continuous Manufacturing , Vertex Pharmaceuticals, Inc. USA

16:15 16:30 (15 mins)

Cell Line Development and Engineering

Variations in the CHO cell mitochondrial genome and post-transcriptional regulation of mitochondrial function

  • Deep sequencing of the mitochondrial genome reveal differences across CHO cell lines
  • miRNAs can influence the mitochondrial function of CHO cells
  • Better understanding of this organelle in CHO cells could lead to improvements in CHO production phenotypes
  • Niall Barron, Ph.D. - Director, National Institute for Cellular Biotechnology

16:15 16:45 (30 mins)

Viral Safety for Biologics

Viral Safety Testing of Vaccines and other Biological Products: A New Analytical Strategy

  • Laurent Mallet - ‎Associate VP, Head of Analytical R&D Europe, Sanofi Pasteur, France

16:15 17:15 (60 mins)

Vaccine Manufacturing

Emerging viral risks: Roundtables

Emerging viral risks to be covered:

  • Zika Virus
  • Ebola Virus
  • Chikungunya Virus
  • Pandemic Influenza

Topics for discussion include:

  • Market analysis
  • Development
  • Predicting vaccines for diseases that aren’t prevalent yet
  • Biomarkers
  • Rapid response to new viral threats
  • Dan Adams - Executive Chairman and Global Head of Business Development, Protein Sciences Corporation, USA
  • Jerald Sadoff - Senior Advisor to CEO, Janssen Infectious Diseases and Vaccines, The Netherlands

16:15 16:45 (30 mins)

Downstream Processing

Dual chromatographic steps screening to develop a polishing process in one week

Development of a Mab purification process is time and product consuming. Since several years now, use of HTS and statistical tools allowed to speed up this step to develop as quickly as possible the purification process. In this context and to enhance process development efficiency, an innovative screening platform has been established into Merck BPS Laboratory using a chromatographic robotic station which is able to perform ~100 chromatographic polishing sequences in one week.

  • Xavier Le Saout - Associate Manager - Biotech Process Sciences Technology & Innovation, Merck Serono, Switzerland

16:15 16:45 (30 mins)

Process Development and Characterisation Strategies

Late stage process characterisation programme for monoclonal antibodies

  • Claire Bénac - Downstream Lab Manager, Sanofi, France

16:15 16:45 (30 mins)

Bioprocess Analytics and Control Strategies

Optimisation of manufacturing controls and process monitoring programmes

  • Syama Adhibhatta - Head of PMA, Bristol-Myers Squibb, USA

16:15 16:45 (30 mins)

Upstream Processing

Towards eliminating the impact of raw material variability in biologics manufacturing: A case study with Poloxamer 188

Protein-based therapeutics are typically manufactured at large scales using recombinant mammalian cells cultured in media comprising complex raw materials, often with more than 50 individual components. Adverse impact of lot-to-lot variability in raw materials on biologics’ process performance and product quality is a source of concern [1,2], emphasizing the constant need to understand the relationship between material attributes and process outputs including critical product quality attributes [3]. Poloxamer 188 (P188), a water-soluble copolymer of ethylene oxide and propylene oxide is one such raw material ubiquitously used in mammalian cell culture bioprocesses to protect suspension-adapted cells from bubble-induced shear stress. Lot performance inconsistency with P188 lots (that met release specifications) has resulted in variable cell growth and product yield for multiple Chinese hamster ovary-based manufacturing processes in Roche network and also reported by others [4]. In collaboration with BASF (P188 manufacturer), an investigation was conducted to decipher the cause of variable cell culture performance associated with multiple P188 lots. Various purification and fractionation techniques were deployed in conjunction with cell-based screening assays to test multiple hypotheses related to presence of low and high-molecular weight species in a subset of lots of varying performance. Presence of small quantities of high molecular weight hydrophobic species was identified as a distinguishing feature of suspect lots. A reversed-phase HPLC-based analytical assay was developed to successfully discriminate between P188 lots of varying performance in cell culture application. Small-scale synthesis and spiking studies were used to investigate the manufacturing process and to develop control measures aiming to ensure lot performance consistency in Kolliphor® P 188 Bio. This investigation exemplifies a meaningful collaboration between the end user (Roche) and the supplier (BASF) to address an ongoing challenge associated with a key raw material used in biologics manufacturing.

  • Salim Charaniya - Principal Engineer/Group Leader, Genentech, USA

16:30 16:45 (15 mins)

Cell Line Development and Engineering

Quantitative phosphoproteomic analysis of recombinant Chinese hamster ovary cells in response to reduced culture temperature

  • Phosphorylation is one of the most important post-translational modifications, playing a crucial role in regulating many cellular processes. Despite this very few studies carried out to characterise the phosphoproteome of recombinant CHO cells in bioprocess-relevant phenotypes.
  • Case study – reduced culture temperature (temperature shift) and other growth-related phenotypes. To date we have identified over 700 differentially expressed phosphopeptides following temperature shift of recombinant CHO cells using quantitative label-free LC-MS/MS phosphoproteomic analysis.
  • Characterized over 4000 CHO-specific phosphorylation sites to date.
  • Phosphoproteins have the potential to be cell engineering targets to improve efficiency of recombinant protein production
  • Paula Meleady - Associate Director, National Institute for Cellular Biotechnology, , Dublin City University

16:45 17:15 (30 mins)

Bioprocess Analytics and Control Strategies

Modernising the analytical control of biologics: Total assay alignment, multi-attribute methods and real-time release

New approaches for the analytical control of pharmaceuticals are already successfully applied in the small molecule area: Online analytical results obtained by Process Analytical Technology (PAT) ending up in a Real-Time Release (RTR) is a reality. For biologics, many elements of such modern approaches can be applied. Biologics even offer unique chances in terms of modernisation of their analytics, which is Total Assay Development (TAA) and Multi-attribute Methods (MAM).

  • Hans-Martin Mueller - Director, Biotech Development , MSD, USA

16:45 17:15 (30 mins)

Viral Safety for Biologics

The development of control materials for NGS-based virus detection

A major safety concern in the production of cell-derived & cell-based medicines is the potential infection of the patient with adventitious agent contaminants in the medicine. PCR-based methods have been very effective in detecting viral nucleic acids, but most methods are specific to individual viral groups. Next generation sequencing (NGS) offers the potential for a single ‘catch-all’ assay, but lacks defined limits of detection sensitivity. To begin address the issue of detection sensitivity, we have studied the detection efficiencies of different control bacteriophage and synthetic nucleic acid types in NGS. Very significant biases were observed in the detection of these control materials as well as significant host-cell contamination. We have explored approaches to minimize both detection bias and contamination of controls.

  • Ross Hawkins - Principal Scientist, Division of Advanced Therapies, NIBSC, UK

16:45 17:15 (30 mins)

Upstream Processing

Development of a data-driven scientific approach to minimise raw material variations and improve bioprocess performance

Bioprocess performance variations could be originated from process equipment such as ultrafiltration filters or biomanufacturing parameters. To identify, track and control variations, a science- and data-driven approach was developed and implemented. The method includes establishment of electronic data collection, multivariate analysis, bench-scale study, and control and monitoring strategy to minimise raw material variability that affects biomanufacturing performance.

  • Weibing Ding - Principal Scientist, Process Development, Amgen, USA

16:45 17:15 (30 mins)

Downstream Processing

A strategy for developing and optimising a scale-down model for a legacy product

The application of scale-down models has proven a valuable tool in the development and optimisation of legacy product manufacture. They enable improved process parameter and characterisation understanding, ensuring equivalence and robustness, and can provide a platform to facilitate technology transfers and process validation without interrupting product manufacture. Here we explore a strategy for developing a scale-down model for a legacy product.

  • Charlotte-Maria Orphanou - Process Development Scientist, Porton Biopharma Ltd. UK

16:45 17:00 (15 mins)

Process Development and Characterisation Strategies

A rational approach for process design of protein conjugation

  • Roger-Marc Nicoud - Founder & CEO, Ypso-Facto, France

16:45 17:15 (30 mins)

Cell Line Development and Engineering

Doing more with less: Higher productivity in CHO cells with lower selection pressure

  • Novel flow cytometry-based methodologies for cell line development
  • Rapid generation of pools and clones with minimal to no selection pressure
  • Impact of media on further process streamlining
  • High productivity populations early in development timeline support fast to clinic initiatives
  • Adding early clone screens helps select cell lines with best fit for intended manufacturing process and product quality
  • Christine DeMaria - Director, Cell Line Development, Sanofi

17:00 17:15 (15 mins)

Process Development and Characterisation Strategies

Investigating subvisible particle formation of monoclonal antibody formulations by grinding stress during drug product processing

Monoclonal antibody (mAb) particle formation observed during bottom mounted mixing and filling by piston pump was investigated to understand the root-cause mechanisms leading to subvisible particle formation. The design of the mixer and the pump plays a critical role and any designs with contacting moving parts may grind the mAb molecules to immediately form particles. The impact of grinding on protein particle formation was assessed based on shear, local heat and cavitation.  

  • Yuh-Fun Maa - Senior Principal Engineer, Genentech/Roche USA

17:15 17:45 (30 mins)

Viral Safety for Biologics

NGS regulatory update

  • How do regulators now see the technology
  • Will it replace all traditional testing
  • What is their position?
  • Arifa Khan - Senior Investigator, FDA/CBER

17:15 17:45 (30 mins)

Cell Line Development and Engineering

Optimising screening within cell line development

  • When should screening begin?
  • Choice of host cell line
  • PQA and necessity of
  • Through put technology to improve screening efficiency
  • Emma Cains, Allergan

17:45 18:15 (30 mins)

Viral Safety for Biologics

Application of NGS to the viral safety of biologicals

  • Commercial applications for the technology i.e. Bulk harvest testing
  • Application of the technology in a GMP environment
  • How is the technology developing, what new applications are we seeing and how are NGS platforms being used?
  • Marc Eloit - Pathogen Discovery Laboratory, Institut Pasteur

17:15 17:20 (5 mins)

Main agenda

Plenary Changeover

17:20 17:50 (30 mins)

Main agenda

Enabling high performance biologics purification platforms using disruptive process technologies and process

Ability to rapidly advance a pipeline of bio-pharmaceutical candidates from discovery to clinical trials and commercial manufacturing depends on being able to implement platformable and scalable manufacturing systems at all stages of candidate development. Over the past 15 years, cell culture part of the process has benefited greatly from increased specific productivity of the cells as well as simplification of the cell culture operation itself through the use of robust cell lines and single use integrated technologies. Unlike the upstream side of the process, purification has not benefited from the principles of simplification or higher specific productivity of unit operations nearly to the same extent. The primary reason is that the purification processes continue to rely on legacy technology and strategy principles.

We present simple examples that a dramatic improvement in mAb purification process performance and robustness is possible through the use of strategies that favor process simplification and intensification and are enabled by novel bioprocessing technologies Furthermore, such approaches can be rapidly implemented at all stages of candidate development, decreasing time to clinic and to market and improving overall process economics.

  • Alexei Voloshin - Global Application Strategy Specialist, 3M Separation and Purification Sciences Division

17:50 18:20 (30 mins)

Main agenda

Inspirational Speaker: Battlefield Medicine: "On Demand" Production of What Doctors Need When Patients Need It

  • Tyler McQuade - DARPA Program Manager for Battlefield Medicine Program and Deputy Director, Defense Sciences Office, USA

18:20 20:30 (130 mins)

Main agenda

End of Conference Day 1 and King's Day Celebrations