Manufacturing

Manufacturers introduce innovations in glass and plastic packaging for injectables.

Detecting viral contaminants in biologic-based medicines-and identifying their source-requires a holistic testing approach.

Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.

This study outlines methods for an alternative protein-polishing process for challenging proteins.

. This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.

DoKaSch Temperature Solutions, a Germany-based provider of climate-controlled air cargo containers, announced that its Opticooler air cargo containers are now available in the United States.

Eurofins Scientific has opened a £4-million (US$5-million) pharmaceutical chemistry and microbiology facility in Livingston, Scotland, to support the company’s product and water testing businesses in the UK.

Nemera is now authorized to handle, assemble, sterilize, and store pharmaceutical drugs and medicinal products for autoinjector combination products at its facility in Neuenburg, Germany.

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

Fresenius Kabi broke ground on a previously announced $250 million expansion of its Melrose Park, IL, manufacturing facility.

UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.

The new 10,000 ft2 of laboratories will be dedicated to the company’s monoclonal antibody platform, which enables rapid access to development and manufacturing capacity.

Bormioli Rocco Pharma, an Italian supplier of glass and plastic packaging, has launched its Delta-molded, type 1 glass vials in North America.

The authors review methods for generating monoclonal antibodies for research and development.

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

A case study demonstrates that affinity chromatography can offer efficiency and scalability for gene therapy manufacturing using viral vectors.

Consider automation early in the rollout of clinical translation and scale up of clinical-trial protocols.

Using a hollow microstructured transdermal system to deliver vaccine directly to the dermis.

The development of emerging therapies poses unique manufacturing and formulation challenges for drug developers as candidates like cell and gene therapies advance through the pipeline.

Focused around Purdue University’s LyoHUB, a new blueprint aims to bring innovation to equipment and processes. One goal? Continuous freeze drying.