Manufacturing

FUJIFILM Diosynth Biotechnologies has finished its new viral vector gene therapy manufacturing facility in Darlington, United Kingdom.

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.

Plasmid DNA (pDNA) is a critical raw material for the manufacture of cell and gene therapies. As this market continues to grow, so too does the demand for high-quality pDNA.

Scientists are leveraging ddPCR technology to get an accurate read on viral titer and vector copy number.

Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide.

Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

Image analysis algorithms coupled with microscopy techniques can be used to characterize aggregates of therapeutic proteins.

Innovations in downstream processing accelerate development, enhance efficiency, and promote sustainability.

Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.

In this episode of Drug Digest, industry experts discuss aseptic processing and manufacturing, including what the future holds in this area and the barriers involved with automated aseptic processing practices.

Rentschler Biopharma, CGT Catapult, and Refeyn aim to use automated and digital technologies to improve AAV manufacturing for gene therapies.

Webinar Date/Time: Thu, Sep 28, 2023 10:00 AM EDT

Sartorius’ Biostat STR now incorporates Repligen’s XCell ATF hardware.

Experts discuss the promise of personalized cancer vaccines through the inherent nimbleness of mRNA platform.

The agreement also lists that AGC Biologics will leverage the company’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei drug substance.

The launch of Alpha Teknova’s new manufacturing facility in Hollister, Calif., increases its capacity for custom reagents for life sciences applications.

Webinar Date/Time: Thu, Sep 14, 2023 11:00 AM EDT

Webinar Date/Time: Tue, Sep 26, 2023 11:00 AM EDT

Under the exclusive agreement, Hikma will commercialize products in Rakuten Medical’s pipeline for cancer treatment in the Middle East and North Africa region.

The site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.

In this episode of Drug Digest, editors discuss what happens in the manufacturing space from a CDMO and a cell/gene therapy perspective.

Stable producer cell lines show real promise despite continued development challenges.

Webinar Date/Time: Wed, Sep 27, 2023 11:00 AM EDT

Under a manufacturing agreement, Northway Biotech will develop a manufacturing process for iTolerance’s fusion protein in development for regenerative therapy.

Kiefel’s new machine is designed to form, fill, and seal up to 6,000 infusion, parenteral nutrition, or dialysis bags per hour.

Burgeoning CGT modalities bring promise and challenges.

Scale-up strategies for cell culture will require a deep understanding of overall bioprocess workflows.