Manufacturing

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

Packaging and transporting large quantities of COVID-19 vaccines pose challenges for the cold chain.

Cytiva’s new facility in Shrewsbury, MA will make equipment such as single-use bioreactors.

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

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.

Freezers, shipping containers, and tracking systems aid distribution of COVID-19 vaccines.

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

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

The collaboration includes the development, commercialization, and supply of Orgenesis’ pipeline in South Korea and Japan and the development and commercialization of Cure Therapeutics’ pipeline on a global basis.

Cytiva is adding process development, media and assay development, and contract development services at its facilities in Korea, Japan, Sweden, and the UK.

A longer-than-expected scale up of raw materials forces Pfizer to cut 2020 vaccine production in half.

Lonza has formed a long-term, strategic collaboration with a global biopharma company for bioconjugation.

Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.

The collaboration addresses the need for risk mitigation plans in cell therapies.

Set to be operational by the first quarter of 2022, the 140,000-ft2 facility will feature up to six 2000-L, single-use bioreactor systems along with additional harvest and purification equipment to produce up to 100 commercial batches annually.

CGT Catapult has launched the Advanced Therapies Skills Training Network, designed to open career opportunities and upskill staff in advanced therapy and vaccine manufacturing in the UK.

The grant will support the advancement of glycoengineering technology for plant-derived proteins developed by a University of Alberta scientist partnered with PlantForm.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

A holistic approach to validation and quality assurance is essential.

Establishing an automated inline dilution system can potentially ease bottlenecking delays resulting from higher upstream yields.

Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.

The industry is moving beyond cleaning’s “low tech” image to embrace science-based limits and statistical approaches to control.

Scaling needs for potential COVID-19 vaccines depend not only on capacity, but also on supply chain challenges and technological hurdles.

Moderna has filed for authorization for its COVID-19 vaccine candidate, which has shown high efficacy and safety in a Phase III trial.

The added space will house a portion of its PVC, polyurethane, silicone, and additional plastic tubing products, as well as its AdvantaPure products.