Manufacturing

Webinar Date/Time: Wed, May 8, 2024 11:00 AM EDT

FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.

Cellares CEO Fabian Gerlinghaus discusses the nuts and bolts of counterflow centrifugal elutriation and electroporation innovations and optimization, while hinting at big news on future release testing of products, as a product itself.

Mapp Biopharmaceutical will use ProBioGen’s GlymaxX technology for the development of an afucosylated antibody against Marburg virus infection

Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.

The evolution of therapeutic modalities drives the adoption of single-use technologies.

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

In a new manufacturing pact, Chime Biologics will produce DT-7012, Domain Therapeutics' antibody candidate for treating cancer that will soon be entering Phase I studies.

Webinar Date/Time: Wed, Apr 24, 2024 11:00 AM EDT

In an interview, Fabian Gerlinghaus of Cellares outlines a paradigm change in both hardware and software, regulatory expansions, and some positive cost outcomes for the CGT field.

The Cell Shuttle platform will manufacture cell therapies for its first clinical trials by the end of the year.

The European company has seen its business increase by 47% in North America.

The Alliance will receive the NSF Regional Innovation Engines Development Award and $1 million in funding.

The facility producer’s new innovation hub will offer manufacturing, life sciences, and infrastructure services.

Cellares CEO Fabian Gerlinghaus shares how an automated, closed-production platform with a small footprint can dramatically impact cost savings and scalability for cell and gene therapies.

Webinar Date/Time: Tue, Mar 26, 2024 11:00 AM EDT

Webinar Date/Time: Friday, April 5, 2024 at 11amEDT | 10am CDT | 8am PDT

Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.

Given the criticality of fill/finish processes, it is clear that automation is the next technological step.

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

The partnership will allow for both companies to provide end-to-end biopharmaceutical manufacturing solutions.

CordenPharma’s new starter kits are designed to enable effective formulation in the development of mRNA-based therapeutics.

This discussion explores how the management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process within the biopharma industry.

Webinar Date/Time: Tue, Apr 9, 2024 2:00 PM EDT

CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.

Challenges in fermentation can be addressed through equipment changes, facility design, and process development.

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

Webinar Date/Time: Thu, Mar 14, 2024 2:00 PM EDT

Webinar Date/Time: Wed, Mar 27, 2024 11:00 AM EDT

Managing the intricacies of sterile product development is imperative for successful and compliant outcomes.