Manufacturing

Editor of Pharmaceutical Technology Europe

Articles

A structured cleaning procedure is essential to ensure the effective cleaning of equipment.

Preserving Process Integrity: The Importance of Equipment Cleaning

The site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.

AGC Biologics Completes Expansion at CGT Manufacturing Site in Milan

ProBioGen’s Lenti.RiGHT is a lentivirus production platform for use in gene transfer applications.

ProBioGen Launches Lentivirus Packaging Cell Line

In addition, personnel, equipment, and facilities from the acquired companies will expand Reaction Biology’s presence in Germany while enabling its global customers to leverage Bioassay’s expansive portfolio of regulated clinical and commercial services.

Reaction Biology Acquires Bioassay GmbH for Increasing Large Molecule Capabilities 

Chris Spivey is the editorial director of 

Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.

Shining a Light on Junior Pharmaceuticals

Jennifer Markarian is manufacturing editor of BioPharm International.

Data analytics, modular equipment, digital tools, and risk-based validation improve speed, flexibility, and quality. 

Streamlining Equipment Quality and Flexibility

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

Principles of Equipment Qualification

Point-of-use manufacturing may lead to a big change in the accessibility of medicines globally. 

Advancing Accessibility through Point-of-Use Manufacturing

Getinge’s new DPTE-EXO with Sleeveless DPTE-BetaBag is an alpha port with an external opening and an integrated funnel for automated aseptic transfer.

Getinge Launches New DPTE-EXO with Sleeveless DPTE-BetaBag for Aseptic Transfer

Si Myra Tyson is a senior technical service associate for the Life Sciences Division of STERIS.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

This article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and 
provides a general cleaning recommendation based on laboratory and field testing.
