Manufacturing

Articles

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination. 

Minimizing Contamination During BioPharm R&D

HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.

BARDA Funds US-based Drug Manufacturing Initiative

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

A contamination control strategy can prevent contamination in sterile product manufacturing. The right system, equipment, and personnel training are also essential to mitigate risk.

Considerations in Contamination Control

Pharmaceutical Technology spoke with John Harmer, director, technical sales at Vanrx Pharmasystems about considerations in choosing the best system and equipment for contamination control in pharmaceutical manufacturing.

Best systems and equipment for contamination control

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

Detecting Contamination in Cell Therapies

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Regulators have exaggerated expectations for simulated media fills. 

Complications in Process Simulation Execution

Organizations involved in aseptic and sterile processing activities must make an effort to comply with current good manufacturing practices.


Good Manufacturing Practices: Aseptic and Sterile Processing

Aaron Mertens is a Microbiologist and Technical Services Manager at STERIS Life Sciences.

Joe McCall, previously with STERIS, is the Associate Director of QA Technical Service at ADMA Biologics.

A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.    

How a Contamination Control Program Impacts Product Sterility

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs. 

Addressing Drug Shortages

Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.

Aseptic/Sterile Processing