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Cambridge Healthtech Institute’s 8th Annual
Optimizing Biologics Formulation Development
Formulation Strategies for Different Stages of Development, New Product Formats,
Device/Delivery Systems and Emerging Analytical Methods

January 18-19, 2016

Each year, the PepTalk Optimizing Biologics Formulation Development meeting brings together an international audience of analytical and formulation scientists from leading industry companies to hear solutions to the most significant challenges in their field. For 2016, the conference focuses on formulation strategies in early and pre-commercial development, the challenges of new molecule and product formats, emerging technologies to support the speed and quality of formulation development, formulation issues for device and packaging systems and problem solving for the challenges in the day-to-day work of protein formulators.

Final Agenda


7:30 am Conference Registration and Morning Coffee

9:00 Chairperson’s Opening Remarks

Tarik Khan, Ph.D., Postdoctoral Fellow, Late-Stage Pharmaceutical and Processing Development, F. Hoffmann-La Roche Ltd.


9:10 Formulation Strategies in an Era of Accelerating Timelines and Novel Biotherapeutic Modalities

Ping Y. YehPing Y. Yeh, Ph.D., Executive Director, Drug Product Formulation Technologies, Process Development, Amgen, Inc.

The advancement of bio-therapeutics to treat unmet medical needs has been progressively expanded to new disease targets. The “biology first and modality second” R&D strategy has been successfully applied to probe human biology, resulting in the engineering of novel protein modalities, many of which bring significant challenges to protein formulation and delivery. In this presentation, formulation strategy and technology considerations that bridge discovery and commercialization will be discussed.

9:45 Probing the Interface of Protein Stability Analysis, Formulation Development and Biosimilarity Assessments

David B. VolkinDavid B. Volkin, Takeru and Aya Higuchi Distinguished Professor, Pharmaceutical Chemistry, The University of Kansas School of Pharmacy

This presentation describes the challenges and opportunities of performing fingerprint analysis of various protein analysis data sets (e.g., higher-order structure, potency, pharmaceutical stability) and applying the results to formulation development and biosimilarity assessment. Topics include mathematical approaches to evaluate combined data sets from analysis of protein stability; applying these tools to a case study comparison of model, well-defined IgG1-Fc glycoforms; and potential future applications to fulllength mAbs and complex biomolecules.

10:20 Coffee Break


10:45 Structure-Based Formulation Effects on Endotoxin Quantification

Tarik KhanTarik Khan, Ph.D., Postdoctoral Fellow, Late-Stage Pharmaceutical and Processing Development, F. Hoffmann-La Roche Ltd.

Parental pharmaceuticals must be monitored for the presence of toxic endotoxins, as they present a serious health hazard. The Limulus Amebocyte Lysate (LAL) assay has become the gold standard for analyzing drug product, but has recently been shown to loose sensitivity to controlled spike-ins in the presence of certain formulation buffers and surfactants. This talk will explore supramolecular endotoxin structure changes based on formulation conditions and their correlated LAL effects.

11:15 Biophysical Characterization of Peptide and Protein Formulations

Per-Olof WahlundPer-Olof Wahlund, Ph.D., Senior Scientist, Biophysics Screening & Characterization Novo Nordisk

Development of pharmaceutical formulations of peptides/proteins is a delicate balance between optimising pharmacological action, safety and stability. Extensive biophysical characterization is required to develop a stable formulation, by combining different biophysical methods it is possible to make a more complete interpretation and to generate crucial information regarding the peptide´s/protein´s solubility, self-association, and interactions with excipients. Illustrating case studies will be presented.

11:45 Integration of High Throughput Formulation Screening into Drug Product Development Process

Vladimir RazinkovVladimir Razinkov, Ph.D., Principal Scientist, Product Formulation Technologies, Amgen, Inc.

High throughput methods provide both speed and efficiency during selection of optimal formulation stability for biopharmaceutical product. It is critical to choose the right methods which are specific to modality and stage of development. High throughput screening methods are not only about fewer resources and faster processes. It is also about information-rich and comparable data suitable for statistical analysis allowing robust characterization and long term prediction of critical stability properties.

12:15 pm Case Stories: Protein and Peptide Stabilization by Formulations with Recombinant Human Serum Albumin Derived from Yeast

Morton_PhilPhil Morton, Ph.D., Senior Manager, Novozymes Biopharma UK Ltd, Biopharma Research & Development

An important property of albumin is its inherent ability to stabilize colloidal systems. The mechanisms involved in the stabilization are multiple and dependent on the specific drug. One well-known mechanism is when albumin is used to coat hydrophobic and hydrophilic surfaces preventing surface-induced aggregation and drug depletion. Mechanisms of stabilization for other degradation pathways are less well understood. Data is presented here that demonstrates the use of albumin in multiple formulations that suggest there are at least 2 different mechanisms.

12:45 Session Break

1:00 Luncheon Presentation I: A Novel Automated System for Buffer Exchange and Concentration of Biopharmaceuticals

Burge_RussellRussell Burge, Ph.D., Applications Scientist, Freeslate Inc.

Protein formulation preparation requires either dilution or buffer exchange of a protein solution into multiple formulation buffers. Traditional approaches for buffer exchange include dialysis, desalting columns, and centrifugal UF/DF devices. While these are all relatively simple and easy, they are also manual, and specifically dialysis and desalting columns do not allow for protein concentration. Recently, Freeslate has developed a novel automated system for efficient buffer exchange and concentration of biopharmaceuticals. In this talk, we describe this system and its application to protein formulation preparation.

1:30 Luncheon Presentation II (Sponsorship Opportunity Available)


2:00 Chairperson’s Remarks

Valentyn Antochshuk, Ph.D., Principal Scientist, Bioprocess Development, Merck

2:05 Characterization of Stability and Small Molecule Related Species in Antibody Drug Conjugates

Colin MedleyColin Medley, Ph.D., Scientist, Genentech, Inc.

Antibody drug conjugates (ADCs) are complex therapeutic agents combining the specific targeting properties of antibodies and highly potent cytotoxic small molecule. One critical quality attribute of ADCs is the purity and stability of the active drug on the ADC, which is difficult to access once the drug is conjugated to the antibody. This talk will highlight some of ways we’re evaluating the small molecule portion of ADCs.

2:35 Factors Impacting the Stability of Multi-Domain Fusion Proteins

Roberto DePazRoberto DePaz, Ph.D., Senior Scientist, Biopharmaceutical Development, MedImmune

Fusion proteins are a class of biopharmaceuticals engineered for longer half-life and multiple specificities. These multi-domain proteins may lack stabilizing interdomain interactions, complicating formulation development. The conformational and colloidal stability of a fusion protein and the individual domains each contribute to overall physical stability. Formulation considerations for fusion proteins will be discussed, including instances where the relative importance of conformational and colloidal stability varies depending on solution conditions.

3:05 Overcoming Formulation and Analytical Development Challenges for Novel Bispecific BEAT® Format

Julie BonvinJulie Bonvin, Ph.D., Lead, Analytical Development Group, Glenmark Pharmaceuticals

Glenmark’s novel bispecific format (scFv-Fab BEAT®) has opened the possibilities of providing a highly efficient treatment of cancer. The format is a fusion of a Fab and a scFv, where scFv arm binds to the target while Fab binds to T-cells, thereby redirecting T-cells to kill tumor cells. Little is known about our novel mAb formats and the presentation will address the issue by providing novel, relevant and contemporary data.

3:35 Protein Therapeutics Production: Personalities and Provisions

Gayathri VasudevanGayathri Vasudevan, Ph.D., Associate Principal Scientist, Analytical and Formulations Development, FUJIFILM Diosynth Biotechnologies

The expression of proteins with therapeutic potential and subsequent processing and purification challenges the goal to maintain a stable and active molecule. Use of advanced analytics and carefully designed studies to characterize these molecules enable the identification of risks in the manufacturing process. Case studies will be presented.

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing

4:30 Impact of Uncontrolled Drug Substance Attributes on Downstream Biologic Product Quality

Shantanu_SuleShantanu Sule, Ph.D., Sr. Engineer, Protein Drug Product & Device Development, Biogen Inc.

This presentation will cover recent findings of how uncontrolled attributes during upstream drug substance process can influence the quality of downstream drug product. Formulation and control strategies will be presented to address such challenges along with opportunities to improve drug product stability. In addition, novel stability study design approaches will be examined specific to high titer and high concentration biopharmaceuticals where such situations can commonly arise.

5:00 Predictive Modeling to Support Early Stage Formulation Stability Analysis for Vaccines and Biologics

Manvi_HasijaManvi Hasija, MBT, Stability Scientist, BRD, Sanofi Pasteur

The talk will focus on advanced kinetic modeling approaches that can be applied for the selection of the most appropriate kinetic equation to describe the degradation rate of biopharmaceuticals subjected to accelerated conditions. Applications of the modeling technique to support expiry date estimation, temperature excursions, formulations ranking, batch to batch comparability and manufacturing process changes will be discussed.


Freeslate6:30-7:45 Welcome Reception in the Exhibit Hall with Poster Viewing

7:45 Close of Day


8:00 am Conference Registration and Morning Coffee


8:30 Chairperson’s Remarks

Hardeep Samra, Ph.D., Senior Scientist, Formulation Sciences, MedImmune

8:35 Bioanalytical Tools for Developability Evaluation

Valentyn AntochshukValentyn Antochshuk, Ph.D., Principal Scientist, Bioprocess Development, Merck

Successful product and process development is heavily dependent on the understanding of molecular properties and liabilities. Choice of analytical tools and stress conditions is critical for product attributes assessment, speed of development, data understanding, connection between preformulation/developability and formulation/process development. Implementation of high throughput and stage appropriate biophysical and biochemical toolbox accelerates feedback on candidate selection, program de-risking and successful pharmaceutical development.

9:05 Considerations and Approaches for Late Stage Formulation Characterization of Biologics

Hardeep SamraHardeep Samra, Ph.D., Senior Scientist, Formulation Sciences, MedImmune

While most early formulation development focuses on screening solution conditions to obtain an optimal product stability profile, late stage formulation development typically involves minimal optimization and a greater focus characterization of the formulation and drug product presentation.  Characterization usually entails evaluating robustness as well as identifying critical quality attributes of the product.  This talk highlights various approaches and methodologies for demonstrating formulation and product robustness, as well as a discussion of various challenges and considerations involved. 

9:35 Discussion with Session Speakers

9:50 Coffee Break in the Exhibit Hall with Poster Viewing


11:00 Evaluation of Incremental Siliconization Levels on Soluble Aggregates, Submicron and Subvisible Particles in a Prefilled Syringe Product

Mark_BraderMark Brader, Ph.D., Biopharmaceutical Industry Consultant, Formulation Development; Former Principal Scientist, Biogen

The evaluation of stability with respect to particles in prefilled syringes is complicated by the presence of silicone oil. To provide insight into the impact of these variables on silicone oil originating specifically from the siliconized prefillable syringe (PFS), a series of studies were conducted at incremental syringe barrel siliconization levels. The peginterferon beta-1a molecule was shown to be stable in the presence of silicone oil and robust with respect to formation of soluble aggregates, submicron and subvisible particles in its PFS siliconized over the range 0-1.2 mg silicone oil per syringe barrel.

11:30 Integrating Design Controls in Formulation Development for Combination Products

Ling LuLing Lu, Senior Principal Scientist, Design Controls, Pharmaceutical Research and Development, Biotherapeutic Pharmaceutical Sciences, Pfizer, Inc.

There are challenges for formulators when developing combination products per Final Rule. This case study will explain: 1) Streamlined process with value added design control activities per Final Rule and FDA draft guidance; and 2) Three kinds of combination products, and design controls based on complexities and risks of products, comparing early phases in clinical and market application, professional and home use.

12:00 pm ΔG UNchained: Developability Assessment and Formulations Optimization of Biologics Using ΔG

Rick Brown, Ph.D., Unchained Labs

Stability optimization and aggregation minimization are important hurdles in the development of biologics. Chemical denaturation is the most accurate way to measure protein stability and determine the impact of formulation conditions. The HUNK fully automates chemical denaturation, enabling the direct determination of protein stability (ΔG) and a quantitative assessment of aggregation. The HUNK is ideally suited to optimize the formulation of mAbs, bispecific antibodies and antibody drug conjugates. We will discuss chemical denaturation and its use for the evaluation of protein stability and formulation condition optimization.

12:30 Session Break

Ajinomoto_Althea12:45 Luncheon Presentation I: Novel High Concentration Formulations of Biotherapeutics Using Protein Crystal Suspensions

Schroete_LynetteLynette Schroeter, Lead Associate Scientist, Crystalomics, Althea


Jesal Patel, Research Associate II, Crystalomics, Althea


High-concentration, low-viscosity crystalline injectable therapeutics have enhanced purity, stability, and delivery options without changing the biochemical or in-vitro characteristics of the molecule. Althea’s Crystalomics® technology is a portfolio of patents surrounding crystallization, cross-linking, and complexation of proteins for therapeutic use. We have successfully developed stable crystalline formulations and GMP manufacturing processes for crystalline bio-therapeutics.

1:15 Luncheon Presentation II (Sponsorship Opportunity Available)

1:45 Close of Conference