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8 am 9 am (60 mins)

Registration and Coffee

9 am 5 pm (480 mins)

CMC Analytical, Comparability and Stability Studies

This course provides a comprehensive overview of the phase-specific requirements for CMC analytical characterization, comparability, release and stability of biotechnology products from the preclinical phase through clinical trials to commercialization and post-approval. Analytical considerations for a wide variety of biopharmaceuticals are discussed, including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (e.g. antibody drug conjugates). Details are presented on establishing and maintaining product reference standards, designing successful comparability tests (including specifics for biosimilar studies), setting meaningful product specifications, conducting forced degradation studies, technology transfer and bridging changes in analytical methods and generating effective stability protocols. Critical elements of laboratory quality practices that significantly impact the reliability of test data from R&D through cGMP are illustrated.

  • Course Instructor Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

9 am 5 pm (480 mins)

Introduction to Biopharmaceutical Manufacturing

This course provides a fundamental understanding of biopharmaceutical manufacturing. Organized along the development path, the course will describe the activities necessary to bring a biopharmaceutical from discovery to market. Included in the course will be the analytical, quality and regulatory challenges as well as the technical activities required. The instructors will discuss how development activities integrate and the best practices for drug substance and drug product production. At the conclusion of the course the attendee will have learned the steps needed to develop and produce a safe and effective biopharmaceutical that meets industry and patient needs. Identified during the course will be how to implement QbD in development and communicating with regulatory agencies throughout development.

  • Course Instructor Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants
  • Course Instructor Frank Riske, Ph.D., Senior Consultant, BioProcess Technology Consultants

9 am 5 pm (480 mins)

Cell-Based Immunotherapies - From Concept to Commercialization

Cell-based immunotherapies have the potential to transform current medical practice and offer an opportunity to effectively manage what were once considered untreatable diseases. Despite a large increase in basic science activity in the cell therapy arena, alongside a growing portfolio of cell therapy trials, the number of industry products available for widespread clinical use correlates poorly with such a magnitude of activity – with the number of cell based therapeutics in mainstream use remaining comparatively low. This course serves to incorporate key aspects of the commercialization process and examines how therapeutic candidates can be successfully translated from basic science into commercially viable products. The course will address fundamental translational barriers spanning the so-called "valley of death" and delineate sustainable and efficient mechanisms that can support the commercialization process. Topic coverage will include preclinical, clinical, manufacturing, intellectual property, regulation and market components.

  • Instructor David Brindley, MEng, DPhil, FRI, FRSA, Chief Scientific Officer; Managing Partner; Senior Research Fellow, Paediatrics, Aegate; IP Asset Ventures; University of Oxford, United Kingdom

9 am 5:10 pm (490 mins)

Symposium Sponsored by Pall Life Sciences

9 am 9:15 am (15 mins)

Chairperson's Opening Remarks

  • Marc Bisschops, Ph.D., Technology Director, Continuous Processing, Pall Life Sciences, Holland

9:15 am 9:45 am (30 mins)

Continuous Bioprocessing with Sophisticated Integrated Automation Strategies at Scale

  • Mark Brower, Ph.D., Associate Principal Scientist, Merck & Co., Inc.

9:45 am 10:15 am (30 mins)

Process Chromatography Platform for the Operation of Continuous Bioprocessing

  • Mark Schofield, Ph.D., Principal R&D Engineer, Pall Life Sciences

10:25 am 10:55 am (30 mins)

Networking Break

Please join us!

10:45 am 11:15 am (30 mins)

Applying ICH Q8/Q9 to Continuous Processing

  • Relevance of QbD/QRM
  • PAT needs/gaps
  • Process Integration and Control
  • Regulatory challenges
  • Mitigation
  • Mani Krishnan, Senior Vice President, Technical and Scientific Affairs, Pall Life Sciences

11:15 am 12 pm (45 mins)

Interactive Panel Discussion: Can the Adoption of Continuous Bioprocessing Technologies in Critical Applications be Accelerated? Which are the Regulatory Points that Concern Customers?

  • Mani Krishnan, Senior Vice President, Technical and Scientific Affairs, Pall Life Sciences

12 pm 1:15 pm (75 mins)

Networking Luncheon

1:15 pm 1:25 pm (10 mins)

Chairperson's Remarks

  • Peter Levison, Technology Development Director, Pall Life Sciences

1:25 pm 1:50 pm (25 mins)

Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities

  • Fernando Garcia, Process Engineer , Just Therapeutics

1:50 pm 2:15 pm (25 mins)

Combining Novel Technologies to Improve Cell Separation and Impurity Removal

  • Laura Dinn, M.Eng., Bioprocess Engineer, Merrimack Pharmaceuticals

2:15 pm 2:40 pm (25 mins)

Continuous Concentration and Diafiltration

2:40 pm 3:05 pm (25 mins)

Perfusion Through Continuous Chromatography

3:05 pm 3:30 pm (25 mins)

An Alternative Cell Clarification Technology: Optimization, Applications and Scale-Up

  • John Armando, M.S., Engineer II, Process Biochemistry, Biogen

3:30 pm 4 pm (30 mins)

Networking Refreshment Break in Foyer

4 pm 4:30 pm (30 mins)

Why CMO Means "Continuous Manufacturing Organization"

  • Michelle Najera, Ph.D., Scientist, Downstream Development, CMC Biologics

4:30 pm 5 pm (30 mins)

Informing the Business Decision - New Models for Continuous Bioprocessing

  • Tom Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc.

5 pm 5:10 pm (10 mins)

Chairperson's Closing Remarks

  • Peter Levison, Technology Development Director, Pall Life Sciences

9 am 5 pm (480 mins)

On Time and within Budget: Successful Program Management of Biologics Development – Tools, Techniques and Lessons Learned

Strong Program Management is critical to the successful completion of biologics programs. This workshop presents proven tools and methodologies while focusing on the idiosyncrasies of biotechnology. We will review the integration and management of R&D, CMC, preclinical and clinical programs from discovery to licensure/commercial launch. We will address partner and supplier management (CMOs, CROs…) as well as the securing and management of program funding (government and private equity).

Topics to be Covered:

  • Biologics Program Management
  • Shrinking development timelines
  • Cross functional integration
  • Working within smaller budgets
  • Becoming more virtual through partnering and subcontracting
  • Integrating biotechnology activities and organizations
  • CMO management
  • CRO management
  • Securing dilutive and non-dilutive funding
  • Peter Latham, President and Managing Partner, Latham BioPharm Group, Inc., PgMP
  • Joshua Speidel, Ph.D., Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc., PMP
  • Gretchen Stup, Senior Consultant, Latham BioPharm Group, Inc., PMP

9 am 5 pm (480 mins)

Modern CMC Regulatory Strategies and Insights - from Concept to Approval

On average, it still takes in excess of 10 years to develop a new biopharmaceutical drug product. It is estimated that the cost of developing a new biopharmaceutical drug product, and taking into account the > 90% failure rate, is over $2 billion. Conscious of this, the modern viewpoint is looking at ways in which to reduce this overall time and cost element. One strategy is to impart an approach of ‘accelerated development’ which, if done sensibly, can present an attractive and viable option. Quality focused planning, e.g. facilitated by quality by design, can also be used to potentially ‘shave off’ time to approval, whilst maintaining all important quality and regulatory maneuverability. Although faster development is attractive, regulatory aspects, particularly regulatory CMC also needs to keep up pace - which presents a number of difficult challenges. Pinch points:

  • Sometimes it may become necessary to ‘challenge the norm’ and push back on certain regulations, within valid reason.
  • FDA Breakthrough Therapy designation and EMA Priority Medicines (PRIME) designation provide an automatic ticket to enter the ‘fast lane’ - so welcome to the reality!
  • Above all it is still important to have a well authored and ‘watertight’ regulatory dossier by which the competent authority will review the drug product in order to issue final marketing approval.

This session provides an overview of modern regulatory CMC strategies which may be selectively applied for a cross range of product classes (e.g. biopharmaceuticals, biologics, advanced therapy medicinal products, biosimilars, vaccines) and how this can be used in consideration for objectively reducing the overall time and cost. This ‘interactive’ session will focus on biopharmaceuticals, biologics, ATMPs, vaccines and biosimilars. Collective team discussions, whiteboard exemplification and work-throughs will be made on key topic points.

Topics to be Covered:

  • Understanding of ‘the nature of the challenge’: from concept to authorization
  • Modern mindsets: Technically driven approaches: ‘accelerated development’ pros and cons
  • Be ready to ‘fast-track’- Breakthrough Therapy designation & Priority Medicines (PRIME); accelerated approval; ‘rolling’ submissions
  • Exploration of the lifecycle of the investigational and final dossier:
  • Breakdown of Timelines: Important Milestones
  • High level dissection of CTD module 3: IND/IMPD – BLA/MAA - essential content and structuring
  • The bridge between US and EU - important considerations
  • Navigation of the essential guidelines and building blocks: biopharmaceuticals, biologics, ATMPs, vaccines, biosimilars; objective strategies of each
  • Using Quality by Design to your best advantage
  • Rest of World (RoW) CMC / regulatory considerations.
  • Case Study of common issues: regulatory CMC
  • Richard Dennett, Ph.D., Director, Voisin Consulting Life Sciences

9 am 9:15 am (15 mins)

Introduction to Rx-360 and our Patient-Centric Work

  • Mark Paxton, CEO, Rx-360 International Pharmaceutical Supply Chain Consortium

9:15 am 10 am (45 mins)

Benchmarking of Industry Best Demonstrated Practices to Mitigate Risk and Enhance Transparency

  • Rob Welsh, Vice President, Bioprocessing Segment Solutions; Board Member & Co-Chair of Supply Chain Security Steering Committee, VWR and Rx-360 International Pharmaceutical Supply Chain Consortium

10 am 10:45 am (45 mins)

Best Practice for Improving Quality Agreement Experience between You and Your Vendor

  • Rick Calabrese, Global Director of Corporate Quality Systems, Sartorius Group North America

10:45 am 11 am (15 mins)

Short Refreshment Break

11 am 11:45 am (45 mins)

Temperature-sensitive Air Freight – How Utilizing Data Can Mitigate Risk

  • Frank Cascante, Regional Director Americas’, Business Development , LifeConex / DHL Temperature Management Solutions

11:45 am 12:15 pm (30 mins)

Overview of the Rx-360 Joint Audit Program

  • Mark Paxton, CEO, Rx-360 International Pharmaceutical Supply Chain Consortium

12:15 pm 1:15 pm (60 mins)


1:15 pm 2 pm (45 mins)

Comprehensive Supply Chain Security Management System

  • Reggie Jackson, Senior Manager Supply Chain Security , Pfizer

2 pm 2:45 pm (45 mins)

Protecting Patients with Serialization: Key Building Blocks

  • Duke Danont, Director Global Supply Chain , Amgen

2:45 pm 3 pm (15 mins)

Short Refreshment Break

3 pm 3:45 pm (45 mins)

Compliance with Good Distribution Practices: How Many Standards?

  • Dave Ulrich, QA Director Supply Chain Compliance , Abbvie

3:45 pm 4:30 pm (45 mins)

Partnering with Suppliers for Improvements; A Supplier Collaboration Program Perspective

  • Jayesh Patel, Supplier Collaborations Manager, Global Supplier Quality and Product Validity, Genentech, A Member of the Roche Group

4:30 pm 4:30 pm (0 mins)

Close of Session

1 pm 4:30 pm (210 mins)

Repligen OPUS® Facility Tour

How do you pre-pack a chromatography column?

Repligen invites you to a tour of its manufacturing facility in Waltham, MA to see how OPUS® Pre-packed Columns are produced for use by biopharma companies worldwide.The tour will guide you through three state-of-the-art ISO700 packing cleanrooms, and demonstrate stringent materials warehousing, preparation, packaging, and quarantine processes. Break-out sessions with subject experts will also be available. Short reception to follow.

All registrations are subject to approval, space is limited. Bus will depart Boston Convention Center at 1pm and arrive back at 4:30pm. 

1 pm 6 pm (300 mins)

[SOLD OUT] Sartorius Site Tour: UniQure Facility in Lexington, MA


Sartorius will be hosting a Site Tour to the UniQure Facility in Lexington, MA on Tuesday, October 4th. Buses will leave the BCEC at 1pm and will return 6pm.  Please select the 'Sartorius UniQure Site Tour' option on the registration page if you would like to attend.  All registrations are subject to approval.

uniQure, a leading fully integrated AAV-based gene therapy company and the manufacturer of the first EU approved gene therapy product Glybera, has graciously offered to share its cutting edge Boston area manufacturing facility through a tour at BPI supported by Sartorius Stedim Biotech. The innovative facility construction implemented a design build process in just 10 months and is capable of simultaneous multi-product production at BSL-2. Capabilities include cell bank and seed stock production, DS production,  DP filling and final product packaging. The facility showcases single-use production scale rocking motion and stirred tank bioreactors up to 500L and a custom automated vial filling system. Please join us for an evening of cocktails and appetizers along with a facility overview and tour. 

View the Lexington Site Layout


7:30 pm 10:30 pm (180 mins)

BPI "BioBrew" Event

Catch the shuttle outside the BCEC for the BPI "BioBrew" Networking event at Harpoon Brewery. Limited capacity; registration required.

Sponsored by Kaneka and Pall Life Sciences