Manufacturing

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Articles

A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics. 

Bigger is Better in Samsung's Approach to Biomanufacturing

Meissner Filtration Products has acquired PDC Aseptic Filling Systems, a supplier of aseptic filling systems and sealers, to expand Meissner's automated platform offerings.

Meissner Acquires PDC Aseptic Filling Systems

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current 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.

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.

The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation. 

Annex 1 Misses the Mark

The company will invest $139 million in sterile manufacturing technology at its facility in Ballytivnan, Sligo, Ireland to support the growth of its oncology pipeline.

AbbVie Expands Oncology Capability at Ireland Site

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.

Compounded Sterile Products Recalled

Sterile-molded filling assemblies from AdvantaPure are suited for single-use vial and syringe filling.

Single-Use Filling Assemblies for Aseptic Fill/Finish Applications

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

Auromedics Pharma Recalls Linezolid Injection Due to Mold Contamination

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

Quality Issues Found at Canadian Facility

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

AMRI Expands Bulk API Aseptic Manufacturing Capacity

LeonardMestrandrea is principal of Mestrandrea Consulting LLC.

Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.

Aseptic/Sterile Processing