Drug Development

The choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.

Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.

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.

The companies collaborate to develop and commercialize ARV-471, an investigational oral PROTAC (proteolysis targeting chimeras) estrogen receptor protein degrader.

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

Modeling the manufacturing process benefits both development and operations.

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?