Manufacturing

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Articles

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

Robotics Solve Aseptic Filling Challenges

AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.

AuroMedics Pharma Issues Voluntary Recall Due to Glass and Silicone Particulates

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan. 

Pfizer to Build Sterile Injectable Facility in Michigan

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

FDA Issues Warning Letter to Baxter’s Drug Manufacturing Plant Acquired in Claris Buy

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines. 


EU and Japan Strengthen Collaboration on GMP Inspection

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Traditional glass and polymeric materials compete for market share in primary packaging for parenteral drug products.

Selecting Primary Packaging for Parenterals

Christian Dunne is Aseptic global product manager at ChargePoint.

The author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including 
isolators, restricted access barrier systems, and split butterfly valve technology.


Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug Manufacturing

Ronak Savla is scientific affairs manager at Catalent Pharma Solutions.

Claus-Michael Lehr is head of the drug delivery department at the Helmholtz-Institute for Pharmaceutical Research Saarland, SaarbrÃ¼cken, Germany.

Brigitta Loretz is a scientist at Helmholtz-Institute for Pharmaceutical Research Saarland, SaarbrÃ¼cken, Germany.

Olga Hartwig is a PhD student at the Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS), SaarbrÃ¼cken, Germany.

William Wei Lim Chin is a technical specialist, science and technology, at Catalent Pharma Solutions.

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

Oral Delivery of Macromolecular Drugs

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Manufacturing, Parenterals and Injectables