Biologics APIs

Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

More biopharma companies choose outside service providers for assay testing.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

BioSC Lab is the first in a line of next-generation chromatography equipment for protein purification in batch and continuous modes.

Reach Separations has announced plans to double its laboratory space at its Nottingham facility as a result of increased demand for its specialist purification services.

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.

The International Conference on Harmonization finalizes Q&A document on APIs.

Experts at Eppendorf discuss common challenges in cell culture and share insights on possible solutions.

Products on display include the newest addition to the Mobius line of single-use bioreactors; Cellvento CHO cell culture media for optimized production of specific cell lines; and new high-volume AFS water purification systems.

Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.

Merus and Selexis will combine technology platforms to produce colorectal cancer combination therapy.

New legislation and changes in policy at FDA are leading to better control of the API supply chain.

Several chromatographic resins are available for downstream purification.

Protecting workers, patients, and the environment requires advanced technologies.

Several chromatographic resins are available for downstream purification.

CMO executives share their opinions on where outsourcing is going and what is driving market change.

After launching a new mammalian cell platform, FUJIFILM Diosynth Biotechnologies U.S.A., has acquired fast-track vaccine manufacturing knowhow and a major presence in Texas’ emerging biocorridor with Kalon, its first acquisition.

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

Recent technology introductions demonstrate that accuracy, efficiency, and usability are top of mind for pharmaceutical industry professionals for analytical instruments.

Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.

Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.

The commercial availability of an increasing diversity of enzymes has led to the growing use of biocatalysts for API synthesis.