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2014 Archived Content

Cambridge Healthtech Institute’s Sixth Annual
Optimizing Biologics Formulation Development
New Product Formats, Emerging Analytical Methods and Solving Problem Formulations
January 13-14, 2014


The Sixth Annual Optimizing Biologics Formulation Development meeting will focus on how the formulation function is responding to the challenges of new product formats, increased regulatory scrutiny and early developability screening of product candidates based on stability and other formulation characteristics. Join your colleagues from around the world in this popular annual discussion of the key challenges and solutions in biologics formulation development, with an emphasis on case studies and lessons learned.

 

Day 1 | Day 2 | Download Development Brochure | Speaker Biographies 

TUESDAY, JANUARY 14

7:15 am Conference Registration

7:30 Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

 

Antibody-Drug Conjugates and Novel Product Formats 

8:30 Chairperson’s Remarks

Mark BraderMark Brader, Ph.D., Principal Scientist, Biogen Idec

 

 

 

8:35 Modulating Molecular Properties of IgG1 through Fc Engineering

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

 

  

 

 

 

9:05 Challenges with Formulation Development of ADCs 

Andrea Ji, Ph.D., Senior Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

There are now commercially available antibody-drug conjugates (ADCs) for the treatment of hematological malignancies and solid tumors including AdcetrisTM from Seattle Genetics and KadcylaTM from Genentech. To streamline development of ADCs to enable preclinical and clinical studies, it is favorable to develop platform processes. This presentation will review strategies for developing a platform formulation suitable for antibody-drug conjugates (ADCs).

9:35 Selected Oral Poster Presentation: Formulation Development and Stability Challenges of Venezuelan, Eastern and Western Equine Encephalitus Virus Virus-Like Particles 

Lisa A. Kueltzo, Ph.D., Formulation Group Lead, Vaccine Production Program, National Institutes for Allergy and Infectious Disease, NIH

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

10:50 Challenges in the Formulation Development for an Antibody-Drug Conjugate

Jianxin Guo, Ph.D., Principal Scientist, Pharmaceutical Sciences, Pfizer

The talk will illustrate the varieties of ADCs and the associated product formulation and process challenges. The application of biophysical techniques on the evaluation of structural stability and aggregation propensity will be introduced. A case study will be used to show the correlation between drug payload and physical instability.

11:20 Formulation Implications for Antibody-Drug Conjugates

Juan DavagninoJuan Davagnino, Ph.D., Senior Director, KBI Biopharma

The formulation approach to have a long-term stable antibody-drug conjugate product, either liquid or lyophilized, has to take into account changes that occur because of the conjugation process. The formulator has to find stable conditions for a heterogeneous product with different chemical and physicochemical properties to the initial homogenous antibody. Some of the changes that occur during conjugation are increased propensity to aggregation, decreased solubility and isoelectric point changes.

Protein Simple

11:50 In Sub-Visible Particle Characterization – Image Is Everything

Olcott_AngelicaAngelica Olcott, Ph.D., MFI Product Manager, ProteinSimple

Imaging techniques such as micro-flow imaging (MFI) measure particle count but also provide shape and size for a diverse range of particle types. Challenging particles such as translucent protein fragments and silicone micro-droplets are easily measured by MFI in either a manual or automated mode. This presentation will provide an overview of MFI technology and its application for the analysis of a wide range of biopharmaceuticals.

Novozymes12:20 pm Luncheon Presentation: Preventing Aggregation of Therapeutic Peptides 

ThostrupBukrinski_JensJens Thostrup Bukrinsk,i Ph.D., Senior Scientist, Pharma R&D, Novozymes A/S

The inherent instability of peptides imposes significant challenges on the process and formulation development of peptide based drugs. Get inspired by novel approaches on how to stabilize peptides in solution. Data will be shared showing novel approaches to prevent peptide aggregation.

 

Buzz Sessions Green 2

2:00 BuzZ Session A (More Details >>)

3:00 Refreshment Break in the Exhibit Hall with Poster Awards

3:45 BuzZ Session B (More Details >>)

4:45 Close of Conference

 

4:30-5:00 Short Course Registration

5:00-8:00 Dinner Short Courses (SC8-SC14) More Details >> 

 

Day 1 | Day 2 | Download Development Brochure | Speaker Biographies