Pharmaceutical Technology Editors

ViraTherapeutics will develop its VSV-GP therapy alone and in combination with other therapies.

FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.

he guidance addresses the good manufacturing practice for managing quality in APIs.

The company is voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

PaizaBio will add aseptic injectable production capacity in Hangzhou, China.

Tapemark, a full-service CDMO specializing in transdermal, oral thin film, and topical drug-delivery technologies, is exhibiting at CPhI.

Could grading finished-drug manufacturers on their quality and efficiency lead to greater transparency, improve quality and reduce drug shortages?

The agency appealed two interim orders to suspend the release of documents requested by third parties.

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.

Gil Roth gives an overview and outlook for the CDMO industry in 2016.

Alan Sheppard, Principal, Global Generics at IMS Health and CPhI expert panel member, discusses generic medicine opportunities in the 2016 CPhI Annual Industry Report.

Three-dimensional (3D) printing, which is a type of additive manufacturing (AM), enables fabrication of specialty drugs and medical devices, said Emil Ciurczak, Doramaxx Consulting and CPhI expert panel member, in the 2016 CPhI Annual Industry Report.

The CDMO has acquired a new building to expand its high-containment manufacturing and development operations.

Sharp will present alongside Tracelink, Systech, Covectra, and Domino during CPhI Worldwide.

Mettler Toledo launched the Rainin BenchSmart 96, a new liquid handling platform.

Containing costs and improving compliance will be crucial to ensuring the growth of generic pharmaceuticals in the future, says Dilip Shah, CEO of Vision Consulting Group, in CPhI’s 2016 Annual Report, which will be formally issued at CPhI 2016 in Barcelona.

STERIS launched the Reliance 300XLS Laboratory Glassware Washer, adding to the company’s line of glassware and plasticware washing systems.

Onset expanded its product line for pharmaceutical cold-chain management with the launch two new products.

The next decade of drug development will depend on better ways of storing, using, and analyzing data, says CPhI advisor Bikash Chatterjee, president and chief science officer of Pharmatech Associates. But each of the following must be optimized: volume, variety, velocity, veracity, and value.

The choice of metrics used to measure the performance of a pharmaceutical operation are crucial, and should be systems oriented.

The most recent PharmSource report says bio/pharma companies have spent more than $150 billion for new plant equipment in the past five years.

The current approach of classifying process parameters and quality attributes as critical or non-critical is too simplistic to adequately reflect current science and risk-based approaches to product quality.

BASF’s new production facility in Shanghai will produce PVP K30 powder, a polymer used as a base for pharma excipients.

Employee empowerment is needed and it begins with senior leaders making adherence to cGMP regulations and compliance with SOPs the normal, easy, and rewarding thing to do.

Pharma’s lack of manufacturing innovation is its biggest shortcoming; but like any other business, investment in this area will need to be justified.

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

FDA and EMA set up new working group on the development of treatments for rare diseases.

Pfizer announced its decision to remain one company after debating the possibility of splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies.

HHS entered into a $43.18 million contract with Sanofi Pasteur for the development of a Zika vaccine candidate.