Manufacturing

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Empty and prefilled syringes must pass a range of quality control tests.

Test Methods and Quality Control for Prefilled Syringes

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.

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

Unknown and Unknowable

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

A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.

Distinguishing Between Cleanroom Classification and Monitoring

Walter Colasante is a vice-president in Charles River Associates’ (CRA’s) Life Sciences Practice. 

Pascale Diesel is a vice-president in Charles River Associates’ (CRA’s) Life Sciences Practice.

The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.

The Link Between Manufacturing and Commercialization in Gene and Cell Therapies

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Closed systems for aseptic fill and finish were featured at INTERPHEX 2019.

Closed Systems for Aseptic Fill and Finish

The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.

Sagent Pharmaceuticals, Inc. Recalls Ketorolac Tromethamine Injection, USP, 60mg/2mL

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.

Managing Biologic Equipment Cleaning

Aseptic Processing Innovations on Display

Agnes Shanley is senior editor of Pharmaceutical Technology.

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

PDA Strengthens its Global Presence

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

Aseptic/Sterile Processing