Manufacturing

Real-time monitoring of product- and process-related impurities remains a challenge.

FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.

Although downstream efficiency still lags behind upstream, engineering-driven innovation is breaking through boundaries.

The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.

Recently released equipment and products include microbioreactor systems, cell therapy automation software, and IIoT-enabled flow sensors.

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

IVERIC bio and Catalent Biologics have entered into a strategic manufacturing agreement for gene therapy product candidates to treat orphan inherited retinal diseases.

The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.

Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.

Dual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy, but must be applied correctly.

Simple components help maintain physical integrity throughout a bioprocess setup, and single-use components play a role in ensuring a closed system for aseptic processing.

Single-use systems offer a solution to the challenges inherent in buffer preparation, which can be the cause of bottlenecking in bioprocessing.

Single-use systems may offer a suitably flexible solution to the biomanufacturing challenges of cost and time-to-market.

This article provides a review of various 2000-L single-use bioreactors used by biopharmaceutical suppliers for commercial production.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.

Jefferson established the Jefferson Institute for Bioprocessing workforce training institute in collaboration with NIBRT using the GE Healthcare FlexFactory Platform to produce biopharmaceuticals.

CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

CDMO iBio introduced cGMP sterile fill/finish services at its facility in Texas.

The learning curve for process analytical technology has slowed widespread adoption.

As cost and time pressures within biopharma are on the rise, innovative expression systems may offer companies a good opportunity to streamline processes early on.

The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.

This article explores the challenges and potential of next-generation therapeutic antibodies.

CDMO, Vibalogics, has revealed that it will be acquired by a private equity firm, Ampersand Capital Partners.

A new facility to be built in the Philadelphia Navy Yard will support commercial production for autologous tumor-infiltrating lymphocyte cell therapy products from Iovance Biotherapeutics.