Manufacturing

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.

The new 40,000-ft2 facility will support Bayer's growing biologics portfolio in oncology, cardiology, and additional therapeutic areas.

Harvard University researchers used single-cell sequencing to identify a protein expressed uniquely by insulin-producing beta cells created from stem cells in the laboratory.

INTERPHEX 2019 presented solutions for ophthalmic containers, materials, and equipment for forming primary containers, child-resistant and tamper-evident (TE) cartons, and cold-chain packaging.

It has been confirmed that both Bulgaria and Cyprus will now be able to perform GMP inspections at a level considered equivalent to the United States

Vibalogics has increased its single-use bioreactor and purification capacity with a new manufacturing for its specialist oncolytic virus and viral vector manufacturing services as a result of a growth in demand.

Dyadic International has announced its collaboration agreement with Serum Institute of India for the development and manufacture of up to 12 antibodies and vaccines using Dyadic’s C1 gene expression system.

The Allen-Bradley ControlLogix 5580 controller from Rockwell Automation is compliant with the IEC 62443-4-2 security standard.

Recipharm Inhalation Solutions is an integrated service for inhalation products.

The FactoryTalk Analytics LogixAI module from Rockwell Automation detects production anomalies.

A solar panel installation at Novo Nordisk’s North Carolina facility was initiated in March 2019 as part of the company’s commitment to zero environmental impact globally.

Automated candle and pressure-plate filtration equipment for removing catalyst residues from API slurries are operated in a closed system.

Managing and controlling e-records is vital for maintaining CGMP data integrity.

The Vaccine Development and Bioprocess Cell Culture Technology Day will take place on May 16, 2019 in Baltimore, MD.

In collaboration with Pall Corportion, biotech company Freeline completed the first full-scale run at its newly commissioned, GMP gene-therapy manufacturing facility in the UK.

A data exchange program between GE Healthcare and Amgen aims to improve biologics manufacturing through analysis of how raw materials affect the process.

Closed systems for aseptic fill and finish were featured at INTERPHEX 2019.

Wabash MPI and Carver’s PNP Series is a new line of pneumatic presses for a variety of applications, including composites molding, laminating, rubber molding, plastics testing, fluid/resin extraction, destructive testing, bonding, cell disruption, and sample preparation.

Wilden added the PS2 25 mm (1-in.) model to its line of Saniflo Hygienic Series (HS) air-operated double-diaphragm (AODD) clamped metal pumps.

The Ross VMC-1000 VersaMix is a 1000-gallon triple-shaft mixer available on a pivot-design single-post hydraulic lift.

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.

While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and enable real-time release.

Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.

Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.

A new facility in Frederick County, MD, will expand the company’s cell therapy manufacturing capabilities.

The expansion of the CDMO’s Skokie, IL facility includes additional refrigeration and freezer space.

The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.

Closed systems for aseptic fill and finish were featured at INTERPHEX 2019.

The ChargePoint Single Use Passive and ChargeBag create a single-use system for contained and sterile transfer of pharmaceutical powders between process steps or facilities.