Manufacturing

The ATMPS and Ori Biotech collaboration aims to improve visibility and reporting of cell and gene therapy manufacturing through a pre-integrated data solution.

Catalent’s new mammalian cell culture suites in Madison, Wis. use single-use bioreactor systems for CGMP clinical and commercial manufacturing.

The China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

The UK's National Horizons Centre has been confirmed as a National Training Centre that will deliver on-site advanced therapies and vaccine manufacturing specific training.

Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.

A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.

The adoption of single-use technologies in fluid-handling systems helps streamline downstream bioprocessing operations.

Breakthroughs in analytics and alternatives to traditional freeze drying promise to reshape biological development and the cold chain.

The companies will aim to establish clinical and commercial supply agreements for Plus Therapeutics’ RNL-liposome drug product at the appropriate stage of development.

The fund will focus on emerging life science companies with novel platforms and methods to improve therapeutic outcomes and those with technologies that support science research, development, and manufacturing.

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.

A growing pipeline of gene therapy candidates aimed at treating neurodegenerative diseases has prompted new guidance.

This agreement enhances GSK’s investment in cell and gene therapy manufacturing in the UK for clinical trials.

The investments are expected to double Thermo Fisher’s manufacturing capacity while creating more than 1500 jobs at 11 manufacturing sites in the Americas, Europe, and Asia.

With funding from the federal government, Merck will expand capacity to produce J&J’s COVID-19 vaccine.

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

Overcoming time and cost constraints can help enable seed train intensification efforts to maximize product yield.

The need for real-time monitoring and control has spurred the development of new analytical tools.

Homology Medicines discusses how the clinical-stage biopharmaceutical company met its need for supply of adeno-associated virus vectors.

While manufacturing increases have been implemented for vials and syringes, meeting future market needs remains unpredictable.

Distribution of the first one-dose vaccine for COVID-19 to start in early March.

The expansion, to be completed in April 2021 aims to increase the CDMO’s viral-vector production capacity in Spain.

The second phase of the Myford facility expansion in California will add upstream and downstream processing suites.

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

Integration of Brooks Life Sciences BioStore III automated storage and inventory monitoring solution with Cytiva’s Chronicle software will improve traceability, process control, and monitoring capabilities.

Rentschler Biopharma will establish its manufacturing capability for advanced therapy medicinal products at the CGT Catapult site in Stevenage, UK.

Evonik has revealed plans for investment in the short-term expansion of its specialty lipids production, which are used with mRNA-based COVID-19 vaccines.

The companies will build capacity in Germany that will be ready in 2022 and are exploring options for increasing volume in 2021.