Development

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?

Amid the rush for a SARS-CoV-2 vaccine to deal with the COVID-19 pandemic, a robust risk assessment must be conducted, and mitigation strategies applied.

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

Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.

A unified scale-up approach, as presented here, can be applied to any unit operation.

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.

The acquisition significantly expands Precision Medicine Group’s cell and gene therapy expertise.

The 17,000 m2 facility will serve as a process development and manufacturing site for Chinese companies developing medicines as well as multinationals with manufacturing requirements in China.

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The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.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

Demand for specific advanced laboratory skills creates a positive employment market.

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%.

After a hectic 2020, biopharma looks to deliver on COVID-19 vaccines and move other promising therapies forward.

Essential bio/pharma employees show hard work and dedication can pay off, for patients.

Advances in development, data management, and automation, and closer collaboration with contract development and manufacturing partners, are pushing more therapies closer to commercialization.

Cell-culture optimization may see benefits from a synthetic biology-based approach that improves product titer, quality, and time.

Creativity and collaboration are required to overcome complex method development challenges.

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

The companies are entering into a license and collaboration agreement for the development and commercialization of Relay’s investigational cancer treatment, RLY-1971, a potent inhibitor of SHP2, a molecule that plays a role in cancer cell survival.

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

With the acquisition, Evonik will expand its life science division and its portfolio of functional excipients and biomaterials.

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

Under the terms of the partnership, Colorcon will work to accelerate i2O’s research and development efforts.