Manufacturing

A one-day sign off for batch records is considered a best practice in the industry.

The authors review the various analytical methods that can enable use of PAT.

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European-Union customs in 2011.

Industry wants more innovation, but can suppliers meet customers' needs?

The authors present scale-up from a 5-L fermentor to a 50-L pilot-scale using the criterion of constant power consumption per unit liquid volume.

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.

European and US associations call for continued vigilance against the threat of counterfeit medicines.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

The contract provider needs to know as much as the NDA holder.

Panayiotis P. Constantinides of Biopharmaceutical & Drug Delivery Consulting on growth of nanoparticle delivery systems.

A review of key industry shifts and promises for the future.

Charles H. Squires of Pfenex discusses advances in expression platform solutions.

Industry experts discuss significant achievements. Plus: What's in store for the future.

Ray O'Connor, an operations consultant with NIBRT, addresses aseptic processing, including how to avoid contamination, and cleanroom best practices. Posted May 2012.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has formally adopted a memorandum of understanding (MoU) with key partners for a harmonised, European system for medicines verification.

The UK's Medicines and Healthcare products Regulatory Agency has launched a new anticounterfeiting strategy with the aim of curbing the occurrence of falsified medicines in the county's supply chain.

The author describes expression technology that produces cell lines with high genetic stability.

No matter the time or cost, knowing what's going on inside your facilities is always going to be worth the effort.

Industry experts discuss the benefits and challenges of self-administration of injectable therapies.

A technical rountable featuring Sartorius Stedim Biotech, Pall Life Sciences, 3M Purification, Asahi Kasei Bioprocess, and Bio-Rad Laboratories.

The authors discuss the technology and guidance required to achieve good KM in a biopharmaceutical company.

The authors describe a new assembly for bulk and final drug product filling operations.

New outsourcing industry sectors have become multibillion-dollar industries.

Challenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate into a commercial product.

Demonstration of large-scale stem-cell scale-up.

Recombinant albumin can stabilize a drug product and assist in API release.

Key business considerations when developing biosimilar products virtually.

When a pharmaceutical supply chain is compromised, there can be disastrous consequences, not only for consumers, but also for manufacturers. Without comprehensive security measures, pharmaceuticals are susceptible to counterfeit, diversion, dilution, tampering and deliberate contamination ultimately compromising patient safety.

This article is the second in a two-part series on extractables and leachables.

This article outlines methods, validation standards, and documentation of sterilization of single-use products using gamma irradiation.