Manufacturing

The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.

Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.

Janssen pledges $6 million to Rutgers CSOPS for continuous manufacturing research.

Alexion will construct a biologics facility in Ireland that is its first outside the US.

AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.

This article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

Traditional sterility testing methods can take 14 days or longer to complete, so a growing number of pharmaceutical manufacturers and quality control

The use of disposables requires careful consideration and planning.

Total cost of ownership, including operating costs, must be considered when deciding between flexible and traditional cleanroom systems.

Aging facilities and inadequate quality systems create drug shortages. Preventing them will require harmonized regulations, and management support for continuous improvement and innovation.

Supply chain consortium establishes a working group to address quality problems in India.

Pall has agreed to be acquired by Danaher for $127.20 per share.

Systec & Solutions' HMI hardware and Werum's PAS-X manufacturing execution system are designed to work together.

Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

The VERISEQ nucleation technology offers a commercially viable technique for cryogenically generating a uniform dispersion of microscopic ice crystals (or ice-fog).

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

The company voluntarily recalls select lots of Adrucil due to particulate matter.

Advances in transdermal drug delivery, particularly with microneedles, are enabling a wider range of drugs to be delivered through the skin.

Novo Nordisk announces that it will invest DKK1.5 billion (US$224 million) in a haemophilia treatment manufacturing facility in Denmark.

Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.