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 Squibb
    Francisca Gbormittah - GlaxoSmithKline SED
    Douglas Kamen - Regeneron
    Brittney Mills - AbbVie
    Chakravarthy Nachu Narasimhan - Merck & Co., Inc., Rahway, NJ., USA
    Shubhadra Singh - GlaxoSmithKline R&D
    Elaine S.E. Stokes - BioPhorum
    Erika 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