Manufacturing

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

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.

The COVID-19 pandemic has accelerated the need for modular designs to rapidly expand vaccine production capacity.

The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.

Sterilization of primary packaging is important for vaccines.

Packaging suppliers prepare to meet the demand unleashed by COVID-19 vaccines and treatments.

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.

CDMOs strive for flexible, adaptable processes and fast tech transfer for manufacturing investigational drug products, including COVID-19 treatments and vaccines.

The Double Planetary Mixer from ROSS is suitable for high-precision mixing, granulation, and vacuum drying all in one.

ACG Group introduced the GT 1600 X.ONE, a line of integrated granulation equipment designed for high-volume batch production.

Pharmaceutical Technology spoke with Tania Pereira Chilima, Deputy CTO at Univercells Technologies about their technology and how it can be used in viral vector manufacturing, which is needed for production of some of the COVID-19 vaccine candidates.

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

The expansion will include new suites for the development and clinical manufacturing of drug product intermediates and drug products and cGMP suites for early-phase cGMP manufacture.

Originally announced in March 2020, the acquired facility will be Bora’s first North American manufacturing facility and will serve as its North American headquarters.

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

The expansion is part of a new expansion initiative aimed at increasing flexibility, efficiency, and cost-effective production.

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

The expansion will include a new 25,000-ft2 warehouse, a filling line for flexible plastic containers, a high-speed automated syringe fill line with the ability to fill up to 600 units per minute, and a high-speed automated visual inspection line.

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

A new facility near Frankfurt, Germany expands Avantor's geographic reach and supports the growing demand for scientific research and clinical trial sample storage.

The new super plant, being built in Incheon, South Korea, will have a total biopharmaceutical manufacturing capacity of 256,000 L.

The companies have formed a long-term manufacturing agreement to accelerate the global supply for Lilly’s COVID-19 antibody therapeutics.

The agreement follows a recent announcement that Sartorius plans to invest $100 million in Songdo, South Korea’s bio cluster.

The agreement will allow Roche to use CEVEC’s proprietary ELEVECTA technology, which is designed to enable fully scalable, high-performance AAV vector production in suspension bioprocesses.

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site.

An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.

Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.