Manufacturing

Survey results and record attendance may show positive signs for established and emerging biopharma regions.

Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?

Industry is searching for ways to deal with the criticality of ensuring data integrity.

The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.

Advanced therapy medicinal products pose unique manufacturing challenges that will require appropriate and thoughtful facility design and equipment.

A project funded by BioProNET will investigate optimization for bioprocessing of gene therapy vectors using hydrodynamic fluid flow fields.

A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.

Kimberly-Clark Professional added the Kimtech A5 Sterile Integrated Hood and Mask XL for head shapes, sizes, and hairstyles that pose a challenge to standard aseptic gowning for cleanroom operators.

The acquisition will allow Lonza to further develop technology for scalable autologous cell-therapy manufacturing.

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.

The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.

The new facility will include comprehensive mammalian process development and manufacturing capabilities.

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.

The UCL-Pall Biotech Centre of Excellence will address industry challenges and provide workforce training.

The companies will work together to discover, develop, and commercialize immunotherapies for patients with solid-tumor cancers in a collaboration worth $695 million per program.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.

Non-destructive surface area measurement can improve stability testing.

Specialist biopharmaceutical company, Alvotech, has announced receipt of a manufacturing license from the Icelandic Medicines Agency, applying to its biopharmaceutical facility based in Reykjavik, Iceland.

A collaboration using Pall’s bioprocessing technology in G-CON’s PODs enables flexible continuous bioprocessing and viral vector facility solutions.

Hydrophobic interaction chromatography (HIC) in flow-through mode offers a more efficient and cost-effective polishing/purification process to remove monoclonal antibody aggregates while maintaining purity at ≥99% than a mixed-mode bind/elute procedure.

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.

Testing demonstrates an automated semi-continuous process strategy for viral inactivation with steps that mimic batch processing.