Cambridge Healthtech Institute’s 12th Annual

Optimizing Biologics Formulation Development

Exploring the Future of Tools and Techniques for Formulating Novel Biologic Drug Products

January 20-21, 2020

Part of the Formulation & Stability pipeline

Cambridge Healthtech Institute’s 12th Annual Optimizing Biologics Formulation Development conference is an essential yearly gathering of analytical and formulation scientists from leading industry companies that provides an exchange of scientific developments and emerging technologies in an environment that encourages discussion with colleagues. For 2020, the meeting will address the formulation challenges of emerging modalities, new strategies for predictive analysis at this stage, exciting new analytical methodologies and accelerating and the best practices being employed to overcome formulation challenges.

Final Agenda


4:00 - 6:00 pm Pre-Conference Registration (Sapphire West Foyer)


7:00 am Registration (Sapphire West Foyer) and Morning Coffee (Sapphire West & Aqua West Foyer)

Formulation for Emerging Modalities
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9:00 Organizer’s Welcome Remarks

Kent Simmons, Senior Conference Director, Cambridge Healthtech Institute

9:05 Chairperson’s Opening Remarks

Jainik Panchal, PhD, Associate Principal Scientist, Sterile Formulation Sciences, Merck



9:10 Stability Assessment of Coformulated Antibody Mixtures

Soriano_BrianBrian D. Soriano, Scientist, Discovery Attribute Sciences, Amgen Inc.

Co-formulating two or more drugs can be highly beneficial for therapeutic treatment of disease. There are unique analytical challenges for assessing stability in coformulations. In this study, we describe the stability assessment of 5 mAbs and 6 associated coformulated mAb mixtures before and after thermal stress. The observed data suggest that the stabilities of antibody coformulations were found to be comparable to the stabilities of individual parental mAbs.

9:50 Biologics Co-Formulation Product Development – Challenges and Case Studies

Panchal_JainikJainik Panchal, PhD, Associate Principal Scientist, Sterile Formulation Sciences, Merck

Co-formulated products contain more than one drug as part of a single drug product image. The concept of coformulation is very common for small molecule drugs, which are routinely co-formulated in a single product (e.g., Delstriga®, BikTarvy ®). Recently, there is an increased interest in co-formulation of biologics. However, there are significant challenges due to inherent molecular complexity of proteins. This talk highlights some of the challenges during coformulation development.

10:20 Networking Coffee Break (Sapphire West & Aqua West Foyer)

10:45 The Relevance of Sub-Visible Particulate Matter in Lipid Nanoparticle Products

Gruia_FlaviuFlaviu Gruia, PhD, Principal Scientist, Drug Product Analytical Development, Moderna Therapeutics

Lipid nanoparticles (LNP) are the leading delivery system for mRNA-based therapeutics and vaccines. They are manufactured by microfluidic mixing of a lipid-containing-ethanol-phase and an mRNA-carrying-aqueous-phase. The LNP self-assemble via a rapid antisolvent precipitation process. Although the resulting size distributions are well controlled, due to complex nature of nanoprecipitation, larger particles may develop. The presentation will focus on characterization of particulate matter in LNP formulations. Selected case studies will be included.

11:15 Drug Product Development Approach across a Multi-Modality Parenteral Product Portfolio

Jason Fernandez, Senior Scientist, Biogen

At Biogen, we are developing a diverse portfolio consisting of small molecules, proteins, antisense oligonucleotides and gene therapy to target many neurodegenerative diseases. There are differences in molecular characteristics, route of administration, and supply chain needs between these modalities. To efficiently deliver against these diverse needs, development strategies that leverage established platforms while catering to unique needs of the emerging modalities will be discussed.

11:45 Challenges in Low-Temperature Storage of Cell Therapy Drug Products

McAndrew_PagePage McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services

Low-temperature storage of cell therapy drugs products presents challenges to achieving good packaging system container closure integrity (CCI). These challenges result from (1) differences in thermal expansion coefficients of components, and (2) permeability of gases. This presentation considers the fundamentals of these challenges and how they may be overcome, as well as differences between glass- and polymer-based systems.

12:15 pm Enjoy Lunch on Your Own

Predictive Methods for Formulation Development

2:00 Chairperson’s Remarks

Samantha Pace, PhD, Research Investigator, Bristol-Myers Squibb

2:05 Physics-Based Simulations to Predict Developability of Antibody Therapeutics

Izadi_saeedSaeed Izadi, PhD, Scientist, Genentech

This talk will provide an overview of physics-based biomolecular simulations and molecular modeling techniques to understand and predict a variety of therapeutic antibodies developability characteristics such as chemical degradation, high viscosity in concentrated solutions, effect of formulation on viscosity, and aggregation. For each category, theoretical and computational models from our group, along with their benchmarking against experimental datasets, will be presented and the models’ accuracy, robustness and pitfalls will be discussed.

2:35 Development of Scale-Down Assays for Assessment of Mechanism(s) of Tangential Flow Filtration Instability of Proteins

Pace_SamanthaSamantha Pace, PhD, Research Investigator, Bristol-Myers Squibb

Interfacial stresses can play a major role in unfolding and aggregation of proteins. The development of a predictive tool to access the risk of molecules when exposed to this stress can help identify the need for different formulations and handling techniques. This talk will discuss the use of Langmuir trough to measure air/water interfacial properties of several molecules and their correlation to aggregation during the ultrafiltration/diafiltration using tangential flow filtration (TFF).

3:05 Find Your Table and Meet Your BuzZ Session Moderator

3:15 BuzZ Sessions with Refreshments

Join your peers and colleagues for interactive roundtable discussions.

Click here for more details

4:30 Formulation of Stable Complexes for Intracellular Delivery of Therapeutic Antibodies

Champion_JulieJulie Champion, PhD, Associate Professor, Chemical and Biomolecular Engineering, Georgia Tech

To enable antibody access to “undruggable” intracellular protein targets, we have developed a self-assembling protein carrier comprised of a self-assembling hexamer barrel with six antibody binding domains that bind the constant region of any antibody. We have performed extensive molecular characterization to understand the loading, dynamics and stability of our assemblies. We have demonstrated intracellular delivery of functional antibodies, and have characterized the uptake, trafficking and fate of internalized antibodies.

5:00 Calculating the Ea Activation Energy and Aggregation Propensity of mAbs Utilizing DSC Differential Scanning Calorimetry

Ralf Carrillo, PhD, Associate Principal Scientist, Pharmaceutical Science, Merck

5:30 A Split β-Lactamase Platform to Predict the Developability of Biopharmaceuticals

Ebo_JessicaJessica Ebo, Researcher, Astbury Center for Structural Molecular Biology, University of Leeds, United Kingdom

We have developed an in vivo platform to characterize the aggregation propensity of biopharmaceuticals that circumvents the need for recombinant expression and downstream analysis. This split beta-lactamase enzyme assay enables the identification of aggregation-prone sequences inserted between the two enzyme domains, whose function is necessary for the survival of the bacteria in which it is expressed. This platform presents a powerful tool for screening drug candidates without any prior knowledge of the mechanism of aggregation.

6:00 - 7:15 Welcome Reception in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)

7:15 Close of Day


8:15 am Registration (Sapphire West Foyer) and Morning Coffee (Sapphire West & Aqua West Foyer)

Overcoming Formulation Challenges
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8:45 Chairperson’s Remarks

Shalini Minocha, PhD, Staff Scientist, Formulation Development, Regeneron

8:50 Formulation Strategies for Labile Protein Molecules: A Bi-Specific Antibody Case Study

Lu_XiaofengXiaofeng Lu, Ph.D., Principal Research Scientist, Pharmaceutical Development, AbbVie, Inc.

Development of a bispecific protein posed significant formulation challenges due to susceptibility to aggregation in aqueous solution. In this talk, the aggregation stabilization approaches explored to develop a formulation for FIH clinical studies and potential formulations for later stage development will be presented.

9:20 Chemical Degradation of Therapeutic Protein Formulations

Mallela_KrishnaKrishna M.G. Mallela, PhD, Associate Professor, Pharmaceutical Sciences, University of Colorado

Methionine oxidation and asparagine deamidation are the two most common chemical modifications that occur during the shelf life of protein pharmaceuticals. I will discuss how to detect such chemical modifications and their effects on the structure, stability, and aggregation of therapeutic proteins using various spectroscopic techniques that include 2D NMR, and methods on how to prevent such chemical degradation.

9:50 Coffee Break in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)

11:00 Effect of Temperature and Intermediate Packaging on Photostability of Biological Products

Minocha_ShaliniShalini Minocha, PhD, Staff Scientist, Formulation Development, Regeneron

Biologic products in Prefilled Syringes (PFS) may be exposed to unintended light exposure when stored in tubs before being labelled, packaged and distributed to clinical sites. The effective light exposure to the formulation in PFS in tubs may vary depending on the orientation, type and intensity of light source and packaging material. The impact of temperature and intermediate packaging on photostability of biologics in PFS will be presented.

11:30 Best Practices for Working with Contract Organizations for Formulation and Process Development

Badkar_AniketAniket Badkar, PhD, Director, Biologics Product Development, Allergan

Working with contract development and manufacturing organizations (CDMOs) is commonplace in the pharmaceutical industry. Outsourcing controls operating costs, streamlines internal resources and company focus, and increases efficiency; however the client will have limited control regarding scheduling, cost, quality and accountability. Data security may become an issue as intellectual property is exchanged. This presentation discusses these points and provides a comprehensive strategy and best practices for selecting and working with CDMOs.

12:00 pm Close of Optimizing Biologics Formulation Development Conference


5:45 - 8:45 Recommended Dinner Short Courses*


SC4: Asset Reacquisition: Planning before Out-Licensing - Detailed Agenda


Deb Harris, Managing Director, Industry Special Services, BDO USA LLP


SC5: Protein Aggregation: Mechanism, Characterization, and Consequences - Detailed Agenda


Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

Kevin Mattison, PhD, Principal Scientist, Malvern Pananalytical, Inc.


*Separate registration required