Manufacturing

Speed to market, flexibility, and digitalization are important topics in biopharmaceutical manufacturing.

Scientific innovation and regulatory reformations are helping to drive the global biopharma market forward, but a balance between cost and value still needs to be accepted for widespread adoption.

Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

Lonza is expanding its microbial development capabilities at its Visp, Switzerland, site to support clinical and commercial drug development programs.

Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.

Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Synthace has raised $35 million in funding to fuel growth of its life sciences R&D technology.

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Fujifilm is expanding its R&D footprint at its California facility.

Baxter will invest $100 million in new lyophilization equipment and an additional aseptic syringe filling line at its Halle/Westfalen (Germany) location.

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

TCR² Therapeutics will add a second clean room to their manufacturing operations.

GenScript’s new gene synthesis center in Piscataway, NJ, is highly automated to accelerate production time and increase supply chain resiliency for biopharma and synthetic biology.

Gentronix has expanded it lab facilities and increased capacity for genetic, ocular, and skin toxicology testing.

Thermo Fisher Scientific showcases its new mass spectrometry and chromatography solutions at the ASMS Conference on Oct. 31–Nov. 4, 2021.

Lonza is expanding its exosomes development and manufacturing capabilities with the acquisition of a service unit from Exosomics and a manufacturing facility from Codiak BioSciences.

Janssen Sciences Ireland was honored for its project execution of a large-scale expansion of biologics drug substance fed-batch capacity.

ADC development is on a positive trajectory from a deeper understanding of therapeutic mechanisms and technological advances.