Manufacturing

Articles

The acquisition of Aptuit's Glasgow, UK and Indiana, US facilities will add sterile injectable formulation development and expand AMRI's analytical services capabilities.

AMRI Acquires Two Aptuit Facilities

Representatives of contract service organizations that specialize in parenteral drug development and manufacturing describe the evolving trends.

CMOs Target Parenteral Drug Development Needs Both Large and Small

Unique Pharmaceuticals has issued a voluntary recall of sterile compounded preparations, but aired concerns about FDA?s recall demand.

Compounding Pharmacy Issues Recall, But Challenges FDA Decision

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics.

Blow-fill-seal Technology Advances in Aseptic Filling Applications

Partner at Jacobs Wyper Architects, 1232 Chancellor St., Philadelphia, PA, 19107, tel: 215.985.0400, www.jacobswyper.com.

In legacy facilities and as buildings age, ensuring cGMP compliance can become complex. A review of a facility's gowning operations can bring insight into the current state of cGMP compliance. The author presents characteristics to look for and questions to ask.

Gowning Practices Provide Clues to cGMP Compliance

Gowning practices embody cGMPs and can be a tool to evaluate cGMP compliance.

Evaluating Facility cGMP Compliance By Reviewing Gowning Practices

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

Players across the biologics value chain are attracted by the advantages of continuous biopharmaceutical manufacturing.

Potential Benefits Drive Interest in Continuous Manufacturing

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

Continuous Bioprocessing Challenges

Challenges encountered when implementing a continuous monitoring system are reviewed.

Achieving and Maintaining Compliance Using Continuous Monitoring Systems

sterilization approach-cycles controlled by differential pressure-is described.

Aseptic/Sterile Processing