Drug Development

The US federal government awarded new funding to the National Institute for Innovation in Manufacturing Biopharmaceuticals, including funding under the American Rescue Plan that will be used to advance vaccine manufacturing.

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

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.

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

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

The future pipeline of complex novel biotherapeutics will require new approaches to analytical assessment.

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

Bi-layer tablets are an under-utilized option that can be employed to help reduce treatment burden, but their formulation is more complex than for conventional monolayer products.

Particle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.

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

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

Modified-release dosage forms present new opportunities for drug developers and can help overcome challenges, such as short biological half-life or poor bioavailability due to degradation in the stomach.

Pharmapack Europe event organizers have revealed increased levels of innovation in drug delivery across the industry, substantiated by the level of regulatory approvals.

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 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.

What can the biopharma industry learn from its rapid response to the COVID-19 pandemic?

CPI has revealed an agreement with DFE Pharma, making it the latest partner of the Medicines Manufacturing Innovation Centre (MMIC) collaboration.

Researchers from the Chalmers University of Technology and AstraZeneca have developed a new method of detecting and testing lipid nanoparticles.

New features of Syntegon’s GKF 60 capsule filler include a piezo dosing system, an Automated Process Development tool, and quick changeover to containment.

VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.

FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.

FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.