Cambridge Healthtech Institute’s Inaugural
Manufacturing and CMC Strategies for Biologics
Developing flexible, compliant biological manufacturing and CMC strategies
Part of CHI's 8th Annual The Bioprocessing Summit
August 15-16, 2016 | Westin Boston Waterfront | Boston, MA

Diverse product pipelines, new facilities, continued process improvements and the pressure to reduce costs through outsourcing is changing the way industry manufactures biotherapeutics.

 CHI’s Inaugural Manufacturing and CMC Strategies for Biologics meeting discusses the latest challenges in developing novel manufacturing strategies, product lifecycle management and improvement, single-use systems and standardization, and CMO management.

Final Agenda

Monday, August 15

8:00 am Short Course Registration

11:30 Main Conference Registration Opens

SINGLE-USE MANUFACTURING & FACILITY DESIGN

1:00 pm Chairperson’s Opening Remarks

Jeffery Odum, Global Technology Partner, NNE Pharmaplan

1:10 Single Use Technologies and Implementation for Biomanufacturing: The Design Manager’s Challenge

    Jeffery Odum, Global Technology Partner, NNE Pharmaplan

As companies develop both short and long-term manufacturing strategies, operational efficiency and utilization become very critical to optimizing cost-of-goods, manpower planning, and supply chain management. This article will provide insights into the challenges faced by Design Managers implementing new single-use technology platforms and the sometimes unforeseen issues they face. The topics will include defining the process and optimizing time-and motion analysis, equipment definition and platform technology analysis.

2:15 Setting Standards in Single-Use Systems: Update from SUTAP, The Single-Use Technology Assessment Program

   Alain Pralong, Ph.D., Senior Vice President, Manufacturing Operations, CellMedica

The shift from traditional to single-use technology is changing the distribution of responsibility and accountability within the drug manufacturing value chain as more components are procured ready-to-use without further modification by the end-user meaning the effective drug manufacturer. This presentation will outline how the creation of SUTAP – the single-use technology assessment program – has progressed, where we stand today and give a comprehensive overview on the next steps.

2:45 Refreshment Break

MANUFACTURING STRATEGIES FOR NOVEL BIOLOGICS

3:15 Analytical Testing Strategy to Support Kadcyla® / T-DM1 Manufacturing Process Validation for Supply Chain Optimization 

   Lan Dai, Ph.D., Associate QA Scientist, Global Biologics Quality Control, Genentech/Roche

Cleaning Validation is a key step to de-bottleneck during manufacturing site transfer. The complexity is increased for ADC product where the cyctotoxic residuals must be removed to be below a pre-determined Maximum Allowable Carryover level after equipment cleaning. A holistic approach has been used in designing the QC testing/validation strategy, including considerations to link downstream analytical testing to the particular cleaning process and to ensure compliance in accordance to local CMO and company network practice..

4:00 An Integrated Platform for Mass Production of Immunotherapy Applications

   Robert Dream, Ph.D., Consultant

Thus far using gene-modified cells has mainly been carried out by investigators who have developed their manufacturing process for small scale clinical trials by using the devices and infrastructure at hand. Anyone who has embarked on the task of manufacturing patient-specific advanced therapeutic medicinal products (ATMP) for clinical use will admittedly agree that it is quite an undertaking.

4:30 Breakout Discussions

This session provides an opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations, or commiserate about persistent challenges.

 Facilities of the Future  
Moderators: 
Jeff Odum, Director, Operations and Biotech Lead, IPS

CMC Strategies for Biosimilars
Moderator:
Beatrix Metzner, Ph.D., Director, Global CMC Strategy & Tech RA, Boehringer Ingelheim Pharma GmbH & Co. KG

5:30 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:00 End of Day

Tuesday, August 16

7:30 am Registration Opens and Morning Coffee

PRODUCT LIFECYCLE MANAGEMENT & CONTINUOUS PROCESS IMPROVEMENT

7:55 Chairperson’s Remarks

Franqui Jimenez, Ph.D., Senior Director, Head of Manufacturing Science and Technology, Genzyme

8:00 Application of Advanced Manufacturing Process Strategies and Analytical Tools for Increased Process Throughput, Improved Product Understanding, and Efficient Process Control

Valerie Tsang, Ph.D., Senior Engineer III, Technical Development, Biogen

In order to meet the potentially high commercial demand for some biologics programs, manufacturing process changes are often necessary during the late stages of clinical product development. To accommodate the anticipated market needs while maintaining consistently high quality products comparable to those used in early phase clinical studies, Biogen has developed and implemented a series of process technologies and analytical tools to increase productivity and throughput, improve process consistency and product understanding.

8:30 Emerging Process Trends in Biologics Development and Manufacturing

Kumar Dhanasekharan, PhD, Director of Process Development, Cook Pharmica LLC

Process Development and manufacturing for recombinant proteins, particularly, in a CMO, needs to be strongly connected together due to tight timelines that are tied to client expectations, which is in turn is driven by speed to clinic. In development, this translates to incorporating new process technologies that align with manufacturing and facility fit needs and concerns. For example, there is a significant need to debottleneck downstream operations due to increasing titers and higher cell densities in cell culture processes. This talk will showcase case study data from multiple emerging downstream technologies that provide overall process intensification across novel harvest clarification technologies, high capacity resins and membrane technologies. Additionally, an upstream process intensification development approach with a N-1 Perfusion option will be discussed which can leverage the improved debottlenecked downstream process.

9:00 Considerations for Implementing a Development Laboratory to Support a Legacy Product

Gregory Walsh, M.S. Associate Director Manufacturing Sciences and Technology Laboratory, Genzyme

When improving upon a legacy process an understanding of the history and the past regulatory strategy of the product should be well understood. However not all legacy products have all the information available that meet current best practices. Lifecycle management of legacy products require continual process knowledge building, manufacturing support, and process improvements which may require regulatory filings. This case study presents the implementation of a development laboratory solely dedicated to a legacy commercial product that is capable of support all aspects of manufacturing and analytics.

9:30 Sponsored Presentation (Opportunity Available)

9:45 Coffee Break in the Exhibit Hall with Poster Viewing

BIOSIMILARS: MANUFACTURING & CMC STRATEGIES

10:30 Biosimilars Manufacturing Strategies: Can New Entities, CMOs and Others Effectively Compete with Big Bio/Pharma?

Eric S. Langer, President and Managing Partner, BioPlan Associates

11:00 Choosing between Patent and Trade Secret to Protect Bioproduction Methods

   Paul Calvo, Ph.D., Director, Biotechnoogy Group, Sterne, Kessler, Goldstein & Fox P.L.L.C.

With estimates that approximately $65 billion worth of biologics will be coming off patent by 2020, the choice of trade secrets versus patent protection has taken on renewed importance in the biotechnology sector. This talk will dicuss choosing between patent and trade secret to protect bioproduction methods.

11:30 CMC Challenges in Practice: Comparability vs. Similarity

   Beatrix Metzner, Ph.D., Director, Global CMC Strategy & Tech RA, Boehringer Ingelheim Pharma GmbH & Co. KG

The impact of manufacturing changes is well understood by means of comparability exercises. Mostly analytical testing is sufficient. The establishment of biosimilarity requires a comprehensive analytical comparability exercise very sensitive to differences and allows determining if a proposed biosimilar is shown to be “highly similar”. Therefore the scientific principle of a biosimilarity exercise is based on the comparability approach.   

12:00 Regulatory CMC for Biosimilars: The Comparability Exercise

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA

For the approval of biosimilars, a meaningful "Finger-Print"-like analysis algorithm is needed to demonstrate similarity of the biosimilar product to the Reference Product. This presentations looks at a stepwise approach starting with analytics to prove highly similar physio-chemical attributes, batch-to-batch variability of the quality attributes of the Reference Product and analytical structural characterisation for biosimilar comparability.

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:15 Dessert Refreshment Break in the Exhibit Hall with Poster Viewing

CMC STRATEGIES TO ACCELERATE TOWARDS IND

1:55 Chairperson’s Remarks

2:00 Latest Developments in the US Biosimilars Market

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA

2:30 Accelerating Timeline to IND by Using Pool for Tox Strategy

Wendy Hsu, Engineer and Group Leader, Early Stage Cell Culture, Genentech

Speed to IND submission is essential in establishing a competitive advantage for a therapeutic product. CMC activities are often on the critical path to IND-enabling toxicology (Tox) studies. The use of a “Pool for Tox” strategy where a pool of clonally derived cell lines is used instead of a single, clonally derived cell line to generate Tox material, can accelerate timelines by several months. The success of the strategy relies on the ability to generate comparable Phase I material using a single, clonally derived cell line.

3:00 A Client’s Perspective- Developing an Accelerated Timeline to File an IND

   Deborah Meshulam, Ph.D., Director, Contract Manufacturing, Scholar Rock

Scholar Rock has developed proprietary technology based on new insights into the structural biology and activation mechanisms of protein growth factors. The process of developing and manufacturing antibodies which can modulate these growth factors can be accelerated to file an IND using a GPEx technology cell line. In this presentation, key parameters and potential risks will be identified and discussed.

3:30 Refreshment Break in the Exhibit Hall with Poster Viewing

IMPROVING MANUFACTURING, FORMULATION & PRODUCT DESIGN

4:15 Novel Stability and Concentration Enhancing Formulations for Improved Administration of Biotherapeutics

   Neil Schauer, Ph.D., Advisor, ReForm Biologics

The current trend in biologic drug delivery is towards development of formulations that enable room temperature stable, high protein concentration drug products in prefilled syringes and auto injectors. This trend requires novel formulation strategies. This presentation addresses product viscosity and stability issues for the improved administration of biotherapeutics.

4:45 Facilitating the Design of Recombinant Protein Therapeutics with the Aid of Comprehensive Genomic Codon Usage Data

   Chava Kimchi-Sarfaty, Ph.D., Principal Investigator, Hematology, FDA/CBER

Codon usage is an active area of research that plays a major role in the expression and folding of proteins, and is especially important in the creation of recombinant therapeutics. However, genomic codon usage data is outdated, inaccurate, or unavailable in existing databases for many organisms, limiting opportunities for research. We are creating a new database to provide codon usage data for every available organism.

5:15 End of Conference

5:15 Registration for Dinner Short Course