Manufacturing

A greater understanding of molecular and cellular biology and technological advancements are revolutionizing the field of biologics.

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

Webinar Date/Time: Fri, May 31, 2024 11:00 AM EDT

ProPharm and PBL have introduced a fully automated, enclosed cell factory manufacturing device.

The two companies will combine their cell therapy platforms to develop convertibleCAR programs targeting solid tumors.

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

Webinar Date/Time: Tue, Jun 4, 2024 9:00 AM EDT

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A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

In this exclusive Drug Digest video interview, Chris Spivey, Director, Industry Relations and Strategic Partnerships, talks with industry experts about various aspects of drug product stability testing.

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.

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

The CDMO plans to expand and upgrade its Philadelphia, Ohio, and Milan facilities to meet the continued growth in demand for high potency handling capabilities.

At INTERPHEX 2024, Pharmaceutical Technology® chatted with Dennis Powers from G-CON Manufacturing about podular cleanroom options and the benefits they offer for manufacturers.

Key areas to invest include manufacturing process improvements, quality management, and AI.

The non-profit initiative puts collaboration at the forefront as it tackles the challenges surrounding recycling primary pharmaceutical packaging.

SK pharmteco, a CDMO, will manufacture, test, and release Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy from Ferring Pharmaceuticals for treating bladder cancer.

The collaboration will combine N4’s nanoparticle delivery system with SRI’s molecular guidance system.

As breakthrough therapeutics in the pharma pipeline approach commercialization, pharmaceutical manufacturing facilities must evolve to meet demand.

A tidal wave of questions floats the need for more upstream automation.

Developing freeze-drying processes requires patience and deep product and process understanding.

In a new agreement, Cellares will utilize its Cell Shuttle fully automated cell therapy manufacturing platform to manufacture select CAR-T cell therapies under development by Bristol Myers Squibb.

A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX 2024.

Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, notes that automation is key when it comes to effective sterile powder transfer of parenteral drug products.

Andreas Frerix, product management director for Quattroflow at PSG Biotech, discussed the advantages and new challenges SUTs present for pumping systems.

New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance.

Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech, shared insights at on how current industry trends are shaping the development and advancement of sensor technologies.

Pharmaceutical Technology® spoke with Nicole Hunter, Watson-Marlow Fluid Technology Solutions’ head of Global WMArchitect, about the impact single-use technologies have on fluid-handling workflows in bioprocessing.

The improvement of ADC manufacturing now demands increased containment requirements and continually advancing analytical detection of molecules in manufacturing spaces.

Wenyu Zhang, PhD, addressed new trends in the aseptic industry and the chief concerns companies should keep in mind while weighing their options, at INTERPHEX 2024.