Contract Manufacturing, Biopharmaceutical Production

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.

The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

A new facility type integrates next-generation mobile cleanroom systems.

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

ABEC, an equipment and engineering company, will provide a custom-made, single-use bioreactor to custom manufacturing firm, Emergent, for its Maryland manufacturing facility.

Hitachi Chemical Advanced Therapeutics Solutions will expand its PCT service platform for cell therapy by adding GMP manufacturing and cleanroom capacity in Allendale, NJ.

Innovation speeds discovery, drives down costs, and improves productivity.

Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.

The Bridgewater facility will provide a range of contract services for biopharmaceutical and pharmaceutical manufacturers, and also serve electronics chemicals suppliers.

Samsung BioLogics signs $55.5 million agreement to manufacture tildrakizumab for Sun Pharma.

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.

Cobra will increase capacity in response to customer demand for DNA and viral vector production.

New study shows China biopharma companies face staffing shortages.

Moving global manufacturing operations may be more complicated than it appears.

Biosimilars may be the key to CMO growth.

Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.

Capacity for complex therapeutics is become increasingly difficult to predict.

Biopharmaceutical manufacturers continue to put quality at the forefront of their relationships.

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.

The new company is the product of a merger with Formex.

Contract biopharmaceutical manufacturing has been growing steadily and is expected to reach $4.1 billion by 2019.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.

Better process development is creating industry benchmarks for bioprocessing.

Althea is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates, in a new facility near San Diego, CA.

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Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.