Manufacturing

CGT Catapult and CATTI have developed aligned training standards for the manufacture of advanced therapies.

BioPharm International® spoke with Stacey Treichler, senior director of Marketing and Strategy for Purolite at Ecolab, about the impact of advanced therapies, new innovations, and sustainability on the biopharmaceutical industry.

Cellular Origins will apply its robotic platform to establish automated CGT manufacturing at CGT Catapult’s manufacturing innovation center in Stevenage, UK.

An ASGCT Panel titled Novel Nucleic Acid and Cell-based Vaccines for Cancer highlights promising mRNA personalized cancer vaccine work.

Under this partnership, AGC Biologics and BioConnection will provide development and manufacturing capabilities for biopharmaceutical drug substance and drug product.

The Mirus Bio acquisition will boost Merck KGaA’s viral vector manufacturing services.

The organizations plan to combine etherna’s experience in mRNA and lipid-based nanoparticles with UHasselt’s autoimmune research to treat a variety of auto-immune diseases.

The rising demand for biologics and technological innovations are driving blow-fill-seal capacity, harnessing manufacturing efficiency, and benefitting patients.

This new facility will allow AstraZeneca to offer full manufacturing processing for antibody drug conjugates.

Regeneron’s Bari Kowal, senior vice-president, head Development Operations & Portfolio Management, gave insight into how the biopharma industry views the application of AI in R&D.

The new drug delivery site will serve to increase Cresset's reach in the region, answering growing demands from its Asia-Pacific consumers.

Studies conducted by a team at Oxford Biomedica demonstrated that HIC can be used to effectively separate non-deamidated capsids from deamidated capsids.

Regeneron’s work in CAR-T cell therapy development includes engineering receptor architecture to improve CAR-T cell sensitivity and improve immune response.

Sven Moller-Tank, PhD, director of Viral Delivery Technologies, Regeneron Genetic Medicines, Regeneron spoke about the use of bispecific antibodies to retarget AAV specificity.

Experiments conducted by the downstream technology team at Spark Therapeutics involving metal ion-containing additives showed improved capsid clearance in AAV production.

Progression in biopharmaceutical drug development and manufacturing is being boosted by technological advances.

This research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes.

Under a partnership, ProPharm and PBL have launched the Cell Factory Box, an enclosed and fully automated cell factory manufacturing device.

The collaboration will target solid tumors using Poseida’s allogeneic CAR-T platform to develop convertibleCAR programs.

Sterile filtration and use of sterile single-use materials provide the best solutions depending on vector size.

Digital transformation is allowing for better handling, analysis, and protection of vast data collection.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Global product manager at Cytiva, Eric Corti, discusses the challenges with designing a new single-use mixing system that ensures leak-free fluid handling operations at INTERPHEX 2024.

The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.

The collaboration aims to scale-up TreeFrog’s process to produce and amplify cells for Vertex’s type 1 diabetes cell therapies.

Contract manufacturer SK pharmteco will manufacture as well as conduct testing and release of Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy for bladder cancer.

At INTERPHEX 2024, BioPharm International spoke with Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, about how to effectively conduct sterile powder transfer during the fill/finish step in parenteral drug product manufacturing.

Current trends, such as single-use technologies, presen advantages and new challenges for pumping systems, according to Andreas Frerix, product management director for Quattroflow at PSG Biotech.

As the industry adjusts to new regulations, including Annex 1, bio/pharma manufacturers must rethink facility designs to remain in compliance.