Development

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Growing demand for bispecific antibodies increases the need for automated and miniaturized high throughput screening capabilities.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, provide answers to frequently asked regulatory questions about advanced therapy medicinal products.

Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.

Meissa Vaccines’s MV-014-212, an intranasal recombinant live attenuated COVID-19 vaccine, induced mucosal and systemic antibodies against SARS-CoV-2 and two variants of concern.

Cellares has entered into a strategic relationship with Poseida Therapeutics to advance a closed, automated, and scalable cell therapy manufacturing system.

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

Developing analytical methods and bioassays is necessary from early on in the drug development life cycle.

Eli Lilly and Company has announced its acquisition of biotech firm Protomer Technologies, giving it a protein-engineering platform for next-generation protein therapeutics.

Sparx Therapeutics will build its first commercial manufacturing facility in Yangzhou, China, for antibody drug production.

GlaxoSmithKline and Alector have partnered to co-develop two mAbs for a range of neurodegenerative diseases, including Parkinson’s and Alzheimer’s disease.

Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.

The collaboration continues as the companies design bioprocess impurity reagent sets to detect residual HCP from HEK 293 cells.

Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.

Catalent expands capabilities for stem cell-based therapies with acquisition of RheinCell’s GMP-grade human iPSCs.

Corbus Pharmaceuticals has licensed two integrin-targeting mAbs, expanding its therapeutics pipeline into inflammatory, fibrotic, and metabolic diseases as well as cancer.

AbbVie has exercised its right to acquire TeneoOne, along with its lead immunotherapeutic asset for the potential treatment of multiple myeloma.

FDA has granted breakthrough therapy designation to donanemab, Eli Lilly and Co.’s investigational antibody treatment for Alzheimer’s disease.

SP Scientific Products’ SP Hull LyoStar 4.0 R&D freeze dryer supports rapid freeze-dry cycle development, optimization, and process scale-up.

The companies have entered into an agreement to develop processes for a novel immunotherapy protein.

The companies will utilize the Cocoon Platform for clinical point-of-care manufacturing.

The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.

The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.

GlaxoSmithKline and iTeos Therapeutics enter into a development and commercialization collaboration worth up to $2.08 billion for a new therapeutic anti-cancer mAb candidate.

Evonik and Stanford University have signed a research collaboration to develop and market a new drug delivery platform for mRNA and gene therapy.