Manufacturing

Kevin Hutter is investigator, Process Engineering and Analytics, Drug Product Development, GSK.

Kashappa Goud Desai is scientific leader, Process Engineering and Analytics, Drug Product Development, GSK.

Igor Rusanov is principal investigator, Process Engineering and Analytics, Drug Product Development, GSK.

Aarti Gidh is director, Process Engineering and Analytics, Drug Product Development, GSK.

Articles

Use of a small-scale filler can result in increased filling efficiency.

Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key Learnings

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Grand River Aseptic Manufacturing Opens Large-Scale Injectable Fill/Finish Facility

The company will invest $24 million into its Inchinnan, Scotland, site to expand global bioproduction capabilities with additional large-volume liquid manufacturing capacity for cell-culture media. 

Thermo Fisher Scientific to Invest $24 Million to Expand Global Bioproduction Capabilities

Through the agreement, Foamix will have access to $20 million of financing to fund the commercial launches of the topical treatments. 

Foamix Enters Manufacturing Agreement with ASM Aerosol-Service for Topical Foam Treatment

AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.

AuroMedics Pharma Issues Voluntary Recall Due to Glass and Silicone Particulates

The company has officially opened a local brand office in South Korean to support its existing business in the region.

Vetter Expands in Asia-Pacific

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

Lilly to Invest $72 Million for Insulin Manufacturing Upgrade

Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.


ICU Medical Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

Sartorius Stedim's New Testing Services to Focus on mAbs and biosimilars

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues. 

Manufacturing, Liquid Drug Products