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Key Sessions

Judy Chou

KEYNOTE PRESENTATION

Bayer Pharmaceuticals

Gerald Gellermann

KEYNOTE: Deploying Appropriate Spending on Analytical Testing To Avoid Wasting Resources

Novartis Biologics

Nov 05
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13:00 - 13:50

Registration

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Showing of Streams
15:00 - 15:30

Afternoon Coffee Break & Networking

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Showing of Streams
17:30 - 18:00

End of Day One

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13:00 - 13:50 50 mins
Registration
13:50 - 14:00 10 mins
Opening Plenary Session
Chairperson's Opening Remarks
14:00 - 14:30 30 mins
Opening Plenary Session
KEYNOTE PRESENTATION
  • Judy Chou - Senior Vice President & Global Head of Biotech; Site Head of Bayer Berkeley CA USA, Bayer Pharmaceuticals
14:30 - 15:00 30 mins
Opening Plenary Session
KEYNOTE PRESENTATION from GE Healthcare
15:00 - 15:30 30 mins
Afternoon Coffee Break & Networking
15:30 - 16:00 30 mins
Cell Line Development
High Speed Cell Line Development for Short Timelines to IND
  • Thomas Jostock, PhD - Science and Technology Lead / Principal Fellow, Novartis, Switzerland
15:30 - 16:00 30 mins
Upstream Processing & Cell Culture
Process Intensification: Intensifying Perfusion Processes for Continuous Manufacturing
  • Dr. Daniel Fleischanderl - Head of Upstream Process Development/ Associated Director, Takeda
15:30 - 16:00 30 mins
Info
Downstream Processing
New Paradigm in ADC Polishing
  • Romas Skudas - Senior Manager, Merck KGaA

We have explored an innovative ion exchange resin in downstream purification of ADC’s, enabling an efficient DAR (drug antibody ratio) species separation for commercially available ADC’s. This showed significant economic advantages compared to other chromatographic modes, assuring high product recovery rates without influencing efficiency. The broad window of operation and ease of use are base for templatability of such method.

15:30 - 16:00 30 mins
Info
Manufacturing Strategies & Bioprocessing 4.0
Learnings and Challenges in Industrialization of Late Stage Biopharmaceuticals
  • Amir Goudarzi - -, UCB

UCB is a global patient-centric biopharma leader. UCB's biologics pilot plant (BPP) in Braine-l'Allued site, Belgium is involved in bioprocess development and clinical drug substance manufacturing. BPP role in industrialization of these molecules, offers an invaluable source of know-how that benefits the rapid and high-quality development of current and future UCB pipeline biologics. Harvest step is a key yield determining step in production of biologics. This step typically requires choosing a sequence of operations to ensure high separation yield, product consistency and reproducibility. This step is impacted by last day broth quality at USP and impacts immediate next DSP step. There are interesting challenges in scaling-in bioprocesses (from development groups), characterizing them and scaling them out to manufacturing sites. With focus on harvest step, this talk will share some case studies of these challenges & subsequent learnings in manufacturing strategies shaping industrialization of biologics.


15:30 - 16:00 30 mins
Bioanalytical & Formulation
KEYNOTE: Deploying Appropriate Spending on Analytical Testing To Avoid Wasting Resources
  • Gerald Gellermann - Senior Fellow, Novartis Biologics
16:00 - 16:30 30 mins
Cell Line Development
Novel Approaches and Technology Implementation to Demonstrate Assurance of Clonality
16:00 - 16:30 30 mins
Info
Upstream Processing & Cell Culture
Comparison of Alternative Perfusion Systems for Intensified (N-1) Inoculum Generation
  • Steven Ruddock - Senior Research and Development Manager, BioPharmaceutical Development, Astra Zeneca

In this study different available perfusion technologies: Single use GE Wave 25; Sartorius BIOSTAT RM (Rocking motion); Stirred tank reactor coupled with Alternating Tangential Flow (ATF) were assessed. Comparable performance between these systems was demonstrated enabling them to be used interchangeably for n-1 bioreactor seed generation, maximising equipment utilisation, simplifying set up and reducing costs.

16:00 - 16:30 30 mins
Info
Downstream Processing
Development and Implementation of a Harmonized Purification Platform for a Modern, Diverse Pipeline
  • Florian Capito, Sanofi Aventus Deutschland

To leverage scientific platform knowledge and simplify transfers, a harmonized DSP purification platform was designed at Sanofi, covering three sites and two continents. Achievements include aligned HTPD methods, implementation of well-defined work packages focused on early phase projects and applicability to vast variety of of Fc-containing molecules. This talk describes the harmonization journey, showing direct application to new projects.

16:00 - 16:30 30 mins
Info
Manufacturing Strategies & Bioprocessing 4.0
Driving Continuous Improvement with Large Scale Manufacturing
  • Ken Green, PhD - Drug Substance Manufacturing Operations, Samsung Biologics

Tactical and strategic initiatives to maximize capacity utilization with a new large scale biologics manufacturing facility.

16:00 - 16:30 30 mins
Bioanalytical & Formulation
Analytics To Reduce Timelines
  • Lorène Bernasconi - Analytical Development Lab Manager, Novimmune SA, Switzerland
16:30 - 17:00 30 mins
Info
Cell Line Development
Bispecific Molecule Formats and Concepts for Cell Line Development
  • Kerstin Assfalg - Scientific Expert Cell Line Development, Boehringer Ingelheim Pharma GmbH & Co. KG

Bispecific antibodies (BsAbs) combine two distinct binding specificities within a single biologic. More than 50 different BsAbs are currently in various stages of clinical development across a number of therapeutic indications (1). These engineered, often antibody-derived molecule formats entering into biopharmaceutical development pose significant challenges on the generation of high-yielding CHO cell factories. This talk will highlight the most recent advances at Boehringer Ingelheim to improve cell line development of asymmetric bispecific difficult-to-express proteins.

16:30 - 17:00 30 mins
Info
Upstream Processing & Cell Culture
Media Development Combined With Frozen Process Intermediates For Intensified Seed Train Expansion
  • Luis Fernando Ayala Solares - Scientist, Life Science, Upstream R&D, Merck KGaA

Seed train expansion of cells before the final production step is often time-consuming and a major source of process variability. For the intensification of seed train operations there are several opportunities discussed across the biopharma industry today. One of the possibilities is to operate N-1 bioreactors in perfusion mode to shorten timelines and improve bioreactor utilization. In this work, we investigated the influence of using an expansion medium especially designed for N-1 perfusion to gain optimal results in the whole manufacturing campaign.

For screening and designing an N-1 perfusion expansion medium, a scale down model which represents a typical production campaign, including the seed train, was established. Expansion medium prototypes were combined with different production media in the final production step, e.g. EX-CELL® Advanced HD Perfusion as medium designed for high-density perfusion, and Cellvento® 4CHO Medium and 4FEED as exemplary fed-batch process.

Our results indicate that using the right companion medium in seed train expansion - specifically designed for the purpose - can prepare the cells optimally for the final N-stage and increase productivity while using low CSPRs. Combining these findings with the application of a perfused N-1 step in the manufacturing campaign leads to a great opportunity for the intensification of the whole upstream process.

Additionally, as another process intensification possibility, a study using high cell density cryopreservation (HCDC) was performed. HCDC is a method of freezing cells in bags instead of vials, at higher cell densities. This leads to the advantage that expansion and production can be decoupled: both steps can be separated in space and time. Room classification could be decreased due to fully closed processing and reproducibility increased due to a reduction of manual handling steps. Besides from advantages in production, these HCDC bags can be highly beneficial in process development for creating equal starting points in experimental setups.

In this study, we developed a single-use bag assembly that supports closed filling and inoculation. These were used to simulate a production campaign in lab scale, using a frozen intermediate for inoculation of the perfused N-1 bioreactor, and a final production step.

16:30 - 17:00 30 mins
Info
Downstream Processing
Two-Step Purification Process for H1N1 Virus Using Ion Exchange Resins
  • Wei Zhang - Associate Staff Scientist, Downstream Processing Group, Bioprocessing Technology Institute of Singapore, A*STAR

An efficient two-step purification process for H1N1 virus production was established using recently developed ion exchange resins. Pretreated H1N1 supernatant was first captured by a wide pore anion exchanger and subsequently polished by a wide pore cation-exchanger. High purity and good overall yield were achieved. This purification process is scalable and adaptable for large scale, thus potentially being an efficient alternative to Influenza A H1N1 vaccine production.

16:30 - 17:00 30 mins
Manufacturing Strategies & Bioprocessing 4.0
Industrialization Aspects of Membrane Affinity Technology
16:30 - 17:00 30 mins
Bioanalytical & Formulation
Risk Assessments Based On Immunogenicity Assays
  • Harry Yang - Senior Director, Medimmune, USA
17:00 - 17:30 30 mins
Cell Line Development
Spotlight Presentation – A Representative from Horizon Discovery
17:00 - 17:30 30 mins
Upstream Processing & Cell Culture
Spotlight Presentation – A Representative from BD Biosciences
17:00 - 17:30 30 mins
Info
Downstream Processing
Spotlight Presentation

A Representative from Pall Life Sciences

17:00 - 17:30 30 mins
Info
Manufacturing Strategies & Bioprocessing 4.0
Spotlight Presentation

A Representative from Sartorius


17:00 - 17:30 30 mins
Bioanalytical & Formulation
Spotlight Session
17:30 - 18:00 30 mins
End of Day One