Once described as “throwing processes over the wall,” tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied. Joseph Szczesiul, director of technical services for UPM Pharmaceuticals, shares best practices.
Cobra, Pall, and Cell and Gene Therapy Catapult are collaborating to develop continuous manufacturing for gene therapy production.
The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.
The acquisition will allow Lonza to further develop technology for scalable autologous cell-therapy manufacturing.
Syngene International’s Jegadeesh Thampi will discuss the significance of engineering data generation to develop robust, safe, and reproducible processes on Oct. 11, 2018 at CPhI Worldwide.
The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.
GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.
The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.
The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.
Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.
Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.
A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.
Traditional barriers between upstream and downstream bioprocessing are slowly starting to break down, as biopharma embraces more advanced analytics and process control.
MilliporeSigma targets emerging biotechs with US development center and global grants.
The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.
Bosch Packaging Technology will introduce its newest R&D device for continuous oral solid dosage production at Achema 2018.
Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.
GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.
Aerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.
Advanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.
Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.
