Manufacturing

A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19.

UK's Prime Minister visited the site of the country’s VMIC in Oxfordshire, and met the teams working at the forefront of the national COVID-19 response.

The radiopharmaceutical CDMO is building a new cGMP facility in Springfield, NJ.

CMDO Piramal Pharma Solutions held a grand opening at a facility they acquired in Sellersville, PA.

A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents.

Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.

The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.

The agreement will Increase global manufacturing capacity for Novavax’s vaccine candidate, NVX-CoV2373, to more than two-billion annualized doses when at full capacity in 2021.

The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.

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 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.

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

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.

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.

Prior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.

Early adopters and equipment manufacturers refine their equipment and processes, paving the way for broader use.