Development

In a pandemic, genetic vaccines offer several advantages over traditional approaches.

Without an independent approval pathway for novel excipients, true pharmaceutical innovation could be stymied.

Various strategies to improve bioavailability are being continuously evaluated, affording greater commercial prospects for the future.

FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.

Through the acquisition, Catalent will establish pDNA development and manufacturing services at its Rockville, MD, facility and will gain Delphi’s team of R&D and genetic engineering scientists, technicians, and regulatory specialists.

Aprecia's compression-free 3DP manufacturing platform and Glatt’s multiparticulate technologies offer solutions to pharmaceutical dosage design challenges.

The companies will co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications.

With the acquisition, Eurofins gets Beacon’s G-protein coupled receptor research knowledge and its compound library.

The company has completed the expansion of its laboratory facilities to accommodate the development of APIs.

The companies have expanded their agreement to include the research and development of new therapies for influenza and other respiratory viruses.

The foundation will provide funding support for the discovery and development of a single-administration, in-vivo gene therapy to cure sickle cell disease, a hereditary blood disease.

Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.

The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.

Through the agreement, AbbVie will use Caribou’s next-generation Cas12a CRISPR hybrid RNA–DNA genome editing and cell therapy technologies to develop two new CAR-T cell therapies.

New approaches to clinical trials, spurred by the COVID-19 pandemic, have dramatically shortened development timeframes. Can these gains be sustained once conditions return to normal?

Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.

Rapid growth in biologics and increasing complexity of new compounds are some of the factors driving development of innovative delivery solutions.

Advanced manufacturing technologies are available, but challenges need to be addressed.

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

Outsourcing partners can provide a multitude of advantages in the development of drug delivery solutions, including those designed for targeted patient populations.

Open communication and transparency coupled with technical expertise foster strong long-term manufacturing partnerships.

Collaboration between equipment suppliers and users is leading to innovation and optimization in biopharmaceutical manufacturing.

The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.

The new US offices will give the company the ability to support its US-based customers on site while continuing to collaborate with its global team.

The collaboration will focus on up to three types of lung and gastrointestinal cancers.

Under the terms of the agreement, operations will be initiated at Lonza’s Houston, TX Center of Excellence where Lonza will handle process development activities for late-clinical and commercial-scale GMP manufacturing of the cell therapy.

The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.

Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%.

Biopharma looks to deliver on COVID-19 vaccines and other promising therapies.