Development

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

GSK has revealed that it has entered into a five-year collaboration with the University of California to advance genomic research and improve drug discovery.

The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.

CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.

Research advances have enabled the application of nanotechnology to drug delivery. What does this technology offer in the way of enhancing therapeutic effect?

This article explores the challenges and potential of next-generation therapeutic antibodies.

Nanobiotix has launched Curadigm, a spinoff company that will specialize in developing a nanotechnology platform for healthcare applications.

MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.

New offering from Catalent targets integrated development and manufacturing of biologic drugs.

Researchers at the University of Sheffield, Sheffield, UK, have discovered and developed a new compound that can kill antibiotic-resistant bacteria, including Escherichia coli.

The companies will develop a new generation of biotherapeutics from cell-line development through to GMP manufacturing.

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.

The acquisition provides Valby, Denmark-based Lundbeck with a discovery platform and a US-based research hub.

Dyadic International has announced its collaboration agreement with Serum Institute of India for the development and manufacture of up to 12 antibodies and vaccines using Dyadic’s C1 gene expression system.

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

Lonza will provide development and manufacturing services to two of Alector’s neurodegeneration drug candidates.

Samsung BioLogics will provide contract development organization services to drug developer GI Innovation.

The companies have entered into a sub-licensing agreement to develop products based on Dyadic’s C1 expression platform and Alphazymes’ enzyme technology.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

Pharma delivers a positive message with renewed efforts to eradicate malaria.

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.

The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.

Educational sessions on the INTERPHEX show floor will include a panel discussion on implementing continuous manufacturing.