Manufacturing

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Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.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

Shingrix represents a new, possibly better alternative to existing treatments.

The agency is looking for industry input on best practices for continuous manufacturing.

Catalent and US WorldMeds have entered into an agreement for the commercial manufacture of lofexidine, a drug used to alleviate opioid withdrawal symptoms.

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

Single-use and single-pass TFF devices are facilitating advances in biopharma manufacturing.

Choosing a suitable material for fill/finish containers begins during the product development stage.

Internet of Things, advanced analytics, and blockchain solutions such as smart contracts promise to give manufacturers more control over products and supply chains.

The control of biologics microbiological impurities, contaminants, and mimetics is evolving.

Protecting against microbiological contaminationover the whole manufacturing process grows increasingly important.