Manufacturing

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.

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

A complicated vaccination rollout and mixed messages may derail the pandemic endgame

Cytiva acquired Vanrx Pharmasystems, a Canadian manufacturer of robotic aseptic filling equipment.

Biotechnology company, Polyplus-transfection, has started construction of a new facility in France to meet growth in the cell and gene therapy market.

The dispute between the European Commission (EC) of the European Union and pharmaceutical company AstraZeneca continues.

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.

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

Sanofi will offer access to its infrastructure and expertise to help BioNTech produce over 125 million doses of its COVID-19 vaccine in Europe.

Clinical material for a Theratechnologies product in development will be produced at PPS’ manufacturing facility in Lexington, KY.

The 40,000-ft.2 facility will feature eight cleanrooms with configurations for the production of cell and viral vector products.

Henogen will be integrated into Thermo Fisher’s Pharma Services business within its Laboratory Products and Services segment.

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.

Acorda’s Chelsea, MA facility will serve as a global center of excellence in the Catalent network for spray-dried dispersion and dry powder encapsulation and packaging.

Baxter will provide commercial-scale manufacturing services at its Halle/Westfalen, Germany facility to prepare Novavax’s COVID-19 vaccine candidate for distribution in the United Kingdom and European markets.

The company plans to expand its global production capacity across six existing manufacturing facilities in Europe and the United States, as well as a new manufacturing facility in the US.

The new facility, which will be operated by Fujifilm Diosynth Biotechnologies, will provide large-scale cell-culture manufacturing of bulk drug substance with 8 x 20,000-L bioreactors.

Intravacc and Cristal Therapeutics have entered into a strategic collaboration for the development of novel vaccine programs against human diseases.

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%.

BioPharm International interviewed Cloudleaf about trends in tracking vaccines through the supply chain.