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Cambridge Healthtech Institute’s 7th Annual
Optimizing Biologics Formulation Development
Case Studies of Problem Solving for Challenging Formulations,
Novel Biotherapeutics and Packaging/Device Systems

January 19-20, 2015


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 2015, the Seventh Annual congress focuses on the correlation of predictive stability studies with actual clinical results, formulating high-concentration proteins, the interface of drug products with delivery and packaging systems and the management of ever-increasing amounts of analytical data in the formulation function. 


Day 1 | Day 2 | Download Brochure | Speaker Biographies 

Final Agenda 


SUNDAY, JANUARY 18


4:00-5:00 pm Short Course Registration

5:00-8:00 Pre-Conference Dinner Short Courses (More Details >>)


4:00-8:00 Main Conference Registration


MONDAY, JANUARY 19

7:30 am Conference Registration and Morning Coffee

9:00 Chairperson’s Opening Remarks

Wei Wang, Ph.D., Research Fellow, Research and Development, Pfizer


Keynote Presentations

9:10 NanoCrud: Roles of Nanoparticles in Aggregation Pathways, Adverse Immunogenicity and Quality Assessment of Therapeutic Proteins

JohnCarpenterJohn F. Carpenter, Ph.D., Professor, Pharmaceutical Sciences; Co-Director, Center for Pharmaceutical Biotechnology, University of Colorado Anschutz Medical Center

Recently, valuable new insights have been gained by characterizing nanoparticles in therapeutic protein products. For example, we found that nanoparticles present in solutions of intravenous immunoglobulin serve as precursors for microparticles during pharmaceutically relevant stresses (e.g., freeze-thawing or agitation). Also, therapeutic proteins can adsorb to foreign nanoparticles, and nanoparticles of therapeutic proteins can induce adverse immunogenicity. Regulatory agencies now view quantitation and sizing of nanoparticles as important for product quality assessment.

9:45 Strategies for Establishing a Formulation Function – A MacroGenics Case Study

TomSpitznagelTom Spitznagel, Ph.D., Vice President, Development, MacroGenics, Inc.

This presentation will discuss some of the challenges in establishing a formulation department at a smaller company. Strategies for balancing risk tolerance, resourcing, outsourcing, and timing will be discussed and illustrated with case studies. In addition to more traditional formulation topics, examples will include ensuring adequate analytics, transferring fill/finish processes, and ensuring dosing strategies are properly selected and supported through compatibility studies.


10:20 Coffee Break


Predictive Analytical Studies in
Formulation Development

10:45 Estimation of Shelf Life Based on Accelerated Stability Data

WeiWangWei Wang, Ph.D., Research Fellow, Research and Development, Pfizer

Product shelf life, a critical quality attribute, needs to be adequate to support worldwide commercialization. One key task during product development is to test, estimate, and optimize product stability. Stability studies are often conducted under accelerated conditions to collect data in a short time period. Such data, however, may not predict accurately the real-time shelf life. This presentation discusses the general principles, challenges, and options in shelf life estimation.

11:15 Roles of Thermal Ramping and Isothermal Analyses in Predictive Formulation Studies

LisaKueltzoLisa A. Kueltzo, Ph.D., Staff Scientist, Formulation Development, Vaccine Production Program Laboratory, National Institutes of Health

Thermal ramping and accelerated high temperature analyses, such as DSC and DSF, have been a staple of formulation development for several decades. The variable ability of these methods to predict the real time stability of biological products has always been a known drawback to this approach, and has been of increasing interest in recent years. This talk will examine the comparative value of accelerated temperature methods with alternate isothermal methods. The benefits and disadvantages of the techniques will be reviewed, and the relative predictive ability for real-time stability will be examined.

11:45 Studies on Developability and Predictive Stability Techniques

DenizTemelDeniz Temel, Ph.D., Postdoctoral Researcher, Technical Development, Biogen Idec

Developability assessment may play an extremely important role in assessment of biomolecule candidates’ behavior and prevention of their possible failure during preclinical and clinical development. Developability studies are integrated with and would bridge between the discovery/design and development/delivery. My research focuses on various measured and calculated properties of monoclonal antibodies that may then serve as predictors and indicators of suitability of these important biomolecules in wide range of concentrations.

12:15 pm Solid State Formulation of Therapeutic Antibodies Using Spray Drying for High Concentration Reconstitution

Breit_JeffJeff Breit, Ph.D., Director, Bend Research

The development of high concentration antibody solutions is being explored for use both in material logistics and storage as well as for clinical application. We will present a case study wherein we begin dissecting the variables important for the development of a spray-dried antibody formulation with a focus on drying kinetics, excipients and protein stability. Utilizing the information accrued in this program, we have developed a model for platform development of a spray-dried monoclonal antibody formulation.

12:45 Session Break

1:00 Luncheon Presentation I: Automated High-Throughput Approaches from Developability to Formulation Development of Biopharmaceuticals

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

Automated high-throughput methods were applied to developability studies and early to late stage formulation development of biopharmaceuticals. Automation integrated with instrumentation generated high quality data and led to highly efficient studies in terms of sample and resource utilization. Results of the case studies highlight the utility and flexibility of laboratory automation and integration with analytical devices such as spectrophotometers, liquid chromatography (HPLC and UPLC) and dynamic light scattering DLS.

1:30 Luncheon Presentation II: Isothermal Chemical Denaturation in the Development of Protein Pharmaceuticals

Freire_ErnestoErnesto Freire, Ph.D., Professor, Biology and Biophysics, Johns Hopkins University

Conformational stability, protein aggregation and solution viscosity are critical issues in the development of protein pharmaceuticals, especially high concentration formulations. Achieving optimal formulation conditions is a difficult balancing act, as excipients used to minimize aggregation or to lower viscosity often have an adverse effect on conformational stability, thus compromising long term stability. The linkage between stability, aggregation and viscosity can be assessed by measuring the free energy of stability (ΔG) and its concentration and time dependence. For monoclonal antibodies and other biologics that exhibit irreversible temperature denaturation, the only way of measuring ΔG is by Isothermal Chemical Denaturation (ICD). Having access to ΔG allows the implementation of more precise and faster formulation optimization algorithms. In this presentation, the fundamentals and applications of ICD to formulation optimization will be discussed.

 


Overcoming Formulation Challenges

2:00 Chairperson’s Remarks

Murali Bilikallahalli, Ph.D., Associate Director, Formulation Sciences, Proteins, Vaccines & Oligos, MedImmune

2:05 Formulation Development for Highly Unstable Proteins

RamilLatypovRamil Latypov, Ph.D., Associate Director, Genzyme





2:35 Pharmaceutical Challenges during Late Stage Development of an ADC

SreedhamAlavattamSreedhara Alavattam, Ph.D., Senior Group Leader, Late Stage Pharmaceutical Development, Genentech, Inc.





3:05 Case Study: Challenges in Developing Multi-Protein/Antigen Drug Products

Murali BilikallahalliMurali Bilikallahalli, Ph.D., Associate Director, Formulation Sciences, Proteins, Vaccines & Oligos, MedImmune

Co-formulated drug products containing two or more therapeutic proteins or engineered vaccine antigens are challenging to develop. But these give significant advantage over mixing of multiple drug products at the bedside in terms of cost of manufacturing and patience convenience. This case study describes some of the formulation and analytical challenges including developability assessment, multi-protein compatibility and overlapping degradation pathways.

3:35 Sponsored Presentation (Opportunity Available)

3:50 Refreshment Break

4:15 Case Study: Handling the Data Deluge in Formulation Development

SteveLaBrenzSteven LaBrenz, Ph.D., Scientific Director, Drug Product Development, Janssen R&D

The adoption of multivariate analysis during formulation development as a requirement QbD may necessitate the use of HTS. The generation of data sets that as a result of HTS are very large and complex quickly limits the productivity gains associated with these techniques. A “small data” approach where data is held in a local database and turned into discreet pieces of information delivers value to laboratory personnel by increasing local productivity.

4:45 Antimicrobial Preservatives in Parenteral Formulations – Practical Implications of Peptide/Preservative Interactions

PetteriHeljoPetteri Heljo, Ph.D., Postdoctoral Researcher, Early Stage Pharmaceutical Development, F. Hoffmann-La Roche

Antimicrobial preservatives such as benzyl alcohol, phenol or m-cresol must be added to parenteral multidose formulations to ensure sterility maintenance during repeated product administration, i.e. multi-use of a parenteral drug product. However, preservatives may interact with API or other excipients, possibly altering their solution properties and physicochemical stability. This presentation explores the relevance of these phenomena in parenterally administered peptide formulations from the perspective of API stability and microbial viability.

5:15 Fluorescence and Light Scattering Methodologies in Biopharmaceutical Development

Malgorzata TrackaMalgorzata Tracka, Scientist II, Formulation Sciences, MedImmune

Platform technologies and approaches are typically utilised by the industry during the bioprocessing of monoclonal antibodies (mAbs). However, recent advances in protein engineering have generated novel ‘non-mAb formats’, which pose new challenges to the formulation scientist. These include new scaffold architectures with associated changes to pI, MW, conformation and colloidal properties and possible self-assembly. Since aberrant protein characteristics have the potential to adversely impact drug product quality, activity, immunogenicity and manufacturability, there is a need for new screening technologies that inform us of the biophysical state of non-mAb formats in a high throughput manner. Using case studies, we will outline new screening assays based on light scattering technologies and fluorescence, enabling us to define the key formulation parameters for early cycle development.

ProteinSimple Large5:45-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing



Day 1 | Day 2 | Download Brochure | Speaker Biographies