Aseptic/Sterile Processing

Isolators move into smaller-volume processes, including cell and gene therapy manufacturing.

Sartorius will invest approximately €270 million (US$305 million) to expand its biopharmaceutical manufacturing activities in South Korea’s biopharm hub.

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

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.

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

Trends and technologies in pharmaceutical manufacturing were highlighted on the show floor and in the conference sessions on the INTERPHEX Innovation Stage.

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

A new GMP facility in Raleigh, NC, and a starting materials facility in Paris, France, give Cellectis end-to-end, in-house manufacturing capacity for its UCART product candidates.

Conventional and robotic automation inside closed systems reduces risk.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

Lonza’s investment in its Stein and Basel facilities in Switzerland aims to expand its overall drug product development and manufacturing services.

CPC’s MicroCNX Series Connectors provide an alternative to tube welding at small tubing sizes.

Microbial experts should employ proactive practices on the manufacturing floor, rather than relying on testing.

Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.

Controlling conditions and preventing contamination are crucial for cell growth.

Summa Equity has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider.

Automation offers benefits for sterile manufacturing in 503B outsourcing facilities.

A task force established by PDA and BioPhorum is establishing scientific data for integrity test activities.

Advances in automation and cleanroom technology improve efficiency for small commercial quantities of aseptically filled drug products.

Aseptic spray drying offers a technology alternative to manufacture thermally stable vaccines.

Blow-fill-seal (BFS) technology presents an economical option for single-unit dose delivery of vaccines.

The semi-automated TipFil Syringe Filler from TurboFil Packaging Machines provides accurate and consistent fills.

ILC Dover’s soloPure flexible aseptic isolator creates a closed environment for sterile filling.

Decontamination, automation, and containment are important considerations for aseptic manufacturing in isolators.

The expanded agreement will include aseptic fill/finish services at its San Diego, CA facility.

Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garment life cycle.

The GENiSYS R from AST (pictured) is a modular system that automates aseptic filling and the closing of vials, syringes, and cartridges.

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

The fill line will work to manufacture high-value APIs for drug product manufacturing to meet the needs of the COVID-19 pandemic.