Manufacturing

BioNTech plans to produce up to 250 million doses of its COVID-19 vaccine candidate, BNT162b2, in the first half of 2021.

The new facility will produce cell therapies for clinical evaluation from discovery through to Phase 2b trials while expanding Takeda’s abilities to develop next-generation cell therapies.

Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.

Broader application of RFID in pharmaceutical packaging benefits caregivers and patients.

Polymeric containers offer an alternative to glass.

Equipment and facility cleaning is crucial, with more extensive protocols needed for some biologics.

The funding will help advance the vaccine’s clinical evaluation, potential marketing authorization, development and manufacturing in Germany, and the number of participants in late-stage clinical trials.

In addition to increasing production, Thermo Fisher will create 1000 jobs across its global manufacturing sites to further automation capabilities and optimize warehouse and sterilization capacity.

The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.

Syntegon’s redesigned continuous band sealers can be configured for various packages.

The investment at its Madison, WI, facility will expand MilliporeSigma’s capacity for high-potent active pharmaceutical ingredient production and allow for continuous flow manufacturing of ADCs.

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

The new facility will be adjacent to Thermo Fisher’s newly expanded biologics manufacturing facility.

The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes.

AMRI will provide AstraZeneca with manufacturing capacity and sterile fill/finish services at its drug product manufacturing facility in Albuquerque, NM.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

The companies have signed a partnership agreement to provide extractables and leachables testing at the SG US Technology Excellence Center in Boston, MA.

The new line will add capacity to Catalent’s pipeline of clinical programs and commercial launches at the site.

Alcami will provide services for Trevena’s OLINVYK (oliceridine) injection, an opioid approved for the management of acute pain severe enough to require an intravenous opioid analgesic in adults.

BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.

Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain.

Risk-based decision-making is impacting all aspects of manufacturing quality from raw material supply to facility inspections.

A device manufacturing process must be carefully designed in the early stages of development to ensure success in commercial manufacturing.

The general principle of lyophilization has hardly changed, but significant advances have occurred in process and product attribute understanding.

Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.

Amid high expectations for a vaccine, bio/pharma readies capacity, weighs pressures.

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

The companies will collaborate on the production of a novel anti-SARS-CoV-2 immunoadhesin in iBio’s FastPharming manufacturing system.

Supply chain traceability is essential in the manufacture of APIs to assure safety and quality.

Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient.