PepTalk 2017
PepTalk 2017
Archived Content

Optimizing Biologics Formulation Development

Day 1 | Day 2 | Download Brochure


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


Candidate Profiling, Developability Assessment, Screening and Optimization

8:15 Chairperson's Opening Remarks

Israel (Rudi) Rubinstein, M.D., Professor of Medicine, University of Illinois at Chicago, Jesse Brown VA Medical Center 

8:20 Effect of Plasticizers on the Storage Stability of Lyophilized Proteins 

Kelly M. Forney-Stevens, Graduate Student in Pharmaceutics, School of Pharmacy, University of Connecticut   

8:50 High-Throughput Profiling of Therapeutic Proteins for Developability Assessment

Kapil Gupta, Ph.D., Research Investigator III, Integrated Biologics Profiling, Novartis Pharma

This presentation will focus on implementation of high-throughput biophysical and biochemical characterization techniques that aid in selecting stable therapeutic proteins for liquid formulation and purification process development. Several case studies will be presented as part of the presentation.

9:20 Miniaturized Developability Assessment of High Concentration Antibody Formulations

Oliver Stauch, Ph.D., Head, Formulation Research Biologics & Parenterals, F. Hoffman-La Roche Ltd.

The protein stability and viscosity behavior may differ significantly between monoclonal antibodies especially for highly concentrated liquid formulations. The feasibility assessment of these formulations is very challenging due to the limited material amounts especially during early phase development. There is thus the need to establish a small scale process using only low material amounts of protein as well as to develop low-volume assay methods. This talk will give an overview of a miniaturized process for high concentration formulation development including sample preparation and a low-volume viscosity method.

Sponsored by
9:50 HTS of Protein Stability and Ligand Binding with Protein Thermal Shift™ Assays on AB qPCR Instruments

Levente Egry, M.Sc., Product Manager, Life Technologies
The Protein Thermal Shift™ Assay is an excellent high-throughput screening method enabling researchers to rapidly monitor protein thermo-stability for optimal conditions that favor stability, screening protein-ligand interactions, and mutations. Temperature-induced protein denaturation is monitored using AB’s Protein Thermal Shift™ Dye.

10:05 Networking Coffee Break in the Exhibit Hall with Poster Viewing

10:45 High-Throughput Screening Methods for Formulation Development of Biotherapeutics and Vaccines

Fernando Ausar, Ph.D., Senior Scientist, Bioprocess Research and Development, sanofi pasteur

A major challenge in formulating biotherapeutic and vaccine products is the identification of optimal conditions for long term storage. Typically, a large number of variables are examined during preformulation development in an effort to identify optimal pH, buffer ingredients, ionic strength and excipients. High-throughput screening is an excellent tool that can be used to identify conditions that maximize their stability. This presentation will highlight recent developments on the high-throughput screening technologies used in formulation development of biotherapeutics and vaccines.

11:15 Novel Nanoformulation of Polymyxin B, a Peptide Antibiotic

Israel (Rudi) Rubinstein, M.D., Professor of Medicine, University of Illinois at Chicago, Jesse Brown VA Medical Center 

Treatment of multidrug-resistant Gram-negative bacteria represents an unmet medical need. Here we show that polymyxin B, a potent peptide antibiotic, self-associates with long-circulating, PEGylated phospholipid nanomicelles. This safer nanoformulation of polymyxin B should be efficacious in treating multidrug-resistant Gram-negative bacterial infections.

11:45 Bioavailability and Activity of Low Viscosity, Ultra-High Concentration Nanoparticle Antibody Dispersions

Jennifer Maynard, Ph.D., Assistant Professor, Chemical Engineering, University of Texas at Austin

Antibodies in solution commonly undergo irreversible aggregation, gelation, and precipitation at concentrations of 100-200 mg/ml. We have created highly concentrated antibody dispersions (up to 350 mg/ml) comprising dense equilibrium nanoclusters of conformationally stable protein molecules, which retain activity upon dilution in vitro or administration in vivo. Dispersions with low viscosity may enable patient self-administration by subcutaneous injection of antibody therapeutics.

12:15 pm Close of Morning Session

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

2:00 BuzZ Session A

2:45 Refreshment Break in the Exhibit Hall with Poster Awards

3:30 BuzZ Session B

4:15 End of Conference;  Registration for Short Courses

4:30 – 7:30 Concurrent Dinner Short Courses (SC5-SC9)*

*Separate Registration Required.

Day 1 | Day 2 | Download Brochure

Links to Companion Meetings

Pipeline 1 

Protein-Device Combinations 

Lyophilization and Emerging Drying Technologies 

Protein Aggregation and Emerging Analytical Tools