Manufacturing, Biologics

The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.

The companies will collaborate to produce and improve the recombinant properties of Aethlon’s Hemopurifier blood purification device.

The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.

The company is investing EUR 170 million (US$201 million) to expand its vaccine manufacturing site in France for its newest influenza vaccine.

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

Groninger will showcase its FlexPro 50 line for small batch production at CPhI Worldwide 2017, and present on up- and downstream processes with freeze-dryer developer and manufacturer Martin Christ.

Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany.

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.

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

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

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.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

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.

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.

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.