Manufacturing

Articles

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

Samsung Biologics Expands Manufacturing Facilities and Launches Cell Line Technology

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.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

Aseptic Processing Practices: Reviewing Three Decades of Change

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines. 


COVID-19: Shoring Up the Drug Delivery Infrastructure

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

Safeguarding against microbial contamination requires rapid detection and innovative technology.

Detecting Microbial Contamination in Bioprocessing

The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.

Ajinomoto Bio-Pharma Services, Humanigen in Manufacturing Agreement for COVID-19 Biologic

Risk aversion is impeding the use of closed aseptic systems, and adding unnecessary cost and complexity to aseptic operations in the pharma industry. 

Risk Aversion Remains an Obstacle to Innovation in Closed Systems

Questions and answers about contemporary closed-system design criteria for aseptic processing equipment

Is the 2006 Technical Document Still Relevant for Today's Closed Aseptic Processing Equipment?

The industry’s aversion to risk has led to its treating closed aseptic processing systems as miniature cleanrooms, resulting in redundant and expensive practices. This article ponders this impasse, examining new technologies and applications in light of  past regulatory guidance and more than 40 years of operating evidence.

Straight Talk on Closed Aseptic Systems

Catalent completes purchase of biologics fill-finish and oral solid dose facility in Anagni, Italy

Manufacturing, Aseptic Processing