Container Closure Integrity of a Glass Prefillable Syringe in Deep Frozen Storage Conditions.

Development of novel pharmaceutical drug modalities has created a need for frozen storage and transportation. Accurate and easy assessment of container closure integrity (CCI) in frozen conditions remains a challenge. Thus, container closure systems (CCS) suitable for low temperatures have been primarily restricted to vials despite the growing popularity of prefillable syringes (PFS) for parenteral administration.

An Experimental and Computational Approach to Development of Mixing Processes for Miscible Liquids in Unbaffled Tanks.

Purpose: Mixing of liquids is a critical unit operation in the biopharmaceutical drug product manufacturing. It commonly consists of mixing miscible liquids to dilute bulk drug substance (DS) or pool multiple lots of drug substance. In the past, at-scale mixing studies have been conducted to determine the mixing parameters, namely mixing speed, and mixing time.

An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies.

The Biophorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Point Share group conducted an intercompany collaboration exercise, which included a bench-marking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: (1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; (2) robustness integrates the principles of quality by design (QbD); (3) DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications; (4) most companies employ robustness studies, along with prior knowledge, risk assessments, and statistics, to develop the DP design space; (5) studies are tailored to commercial development needs and the practices of each company.

Assessing the Impact of Charge Variants on Stability and Viscosity of a High Concentration Antibody Formulation.

Characterizing molecular charge variants or isoforms is essential for understanding safety, potency, and bioavailability of antibody therapeutics. However, there is little information on how they influence stability and viscosity-properties governing immunogenicity and delivery. To bridge this gap, we studied antibody stability as a function of charge variant content generated via bioreactor process.