An intercompany perspective on practical experiences of predicting, optimizing, and analyzing high concentration biologic therapeutic formulations
Broadcast date
Tue, Oct 25, 2022
Presented by
- Preeti Desai - Bristol Myers SquibbFrancisca Gbormittah - GlaxoSmithKline SEDDouglas Kamen - RegeneronBrittney Mills - AbbVieChakravarthy Nachu Narasimhan - Merck & Co., Inc., Rahway, NJ., USAShubhadra Singh - GlaxoSmithKline R&DElaine S.E. Stokes - BioPhorumErika Walsh - Merck & Co., Inc., Rahway, NJ., USA
Quick Description
Presenters talk through the paper published in the Journal of Pharmaceutical Sciences. Developing high-dose biologic drugs for subcutaneous injection often requires high-concentration formulations. It also needs to optimize viscosity, solubility, and stability while overcoming analytical, manufacturing, and administration challenges. Presenters reflect on a set of surveys and discussions that took place over several years in BioPhorum Development Group’s Formulation workstream.
Details
To understand solubility and viscosity, companies desire predictive tools, but experience indicates that these are not reliable and experimental strategies are best. Similarly, most companies prefer accelerated and stress stability studies to in-silico or biophysical-based prediction methods to assess aggregation. In addition, optimization of primary container closure and devices are pursued to mitigate challenges associated with high viscosity of the formulation. Formulation strategies including excipient selection and application of studies at low-concentration to high-concentration formulations are reported. Finally, analytical approaches to high-concentration formulations are presented. The survey suggests that although prediction of viscosity, solubility, and long-term stability is desirable, the outcome can be inconsistent and molecule dependent. Significant experimental studies are required to confirm robust product definition as modeling at low protein concentrations will not necessarily extrapolate to high-concentration formulations.
Speakers

Preeti Desai
Senior Principal Scientist
Bristol Myers Squibb

Francisca Gbormittah
Senior Manager
GlaxoSmithKline SED

Douglas Kamen
Associate Director
Regeneron

Brittney Mills
Principal Research Scientist
AbbVie

Chakravarthy Nachu Narasimhan
Senior Principal Scientist
Merck & Co., Inc., Rahway, NJ., USA

Shubhadra Singh
Scientific Leader
GlaxoSmithKline R&D

Elaine S.E. Stokes
Lead Facilitator
BioPhorum

Erika Walsh
Associate Principal Scientist
Merck & Co., Inc., Rahway, NJ., USA