Manufacturing

Articles

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.

Nephron and Clemson to Develop Robotics for Syringe Filling

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.

Niche APIs By Popular Demand

Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill and finish facility.

Lonza Announces Acquisition of Novartis Drug Product Facility

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

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

Considerations for Sterile Filtration of Biologic Drugs

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

Applying Operational Excellence to Improve Injectable Pharmaceuticals Production

The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.

Premier Pharmacy Labs Recalls All Unexpired Sterile Products

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

Federal Court Decides US Stem Cell Clinics Adulterated and Misbranded Products

The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs. 

USP Publishes Compounding Standards

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected. 

Heritage Pharmaceuticals Inc. Recalls Products Due to Sterility Failure

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Aseptic/Sterile Processing