Manufacturing

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.

How can artificial intelligence and machine learning be used to gather and process real-time manufacturing data?

Lessons learned from the pandemic can advance future biologic drug development and manufacturing.

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

As demand for COVID-19 vaccines increases, Big Pharma offers its manufacturing capacity and expertise.

A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis

WuXi STA will acquire the site’s operations and assets, including the plant, equipment, and workforce.

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.