Aseptic/Sterile Processing

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.

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

SGS’s new Antwerp, Belgium, clinical research site will house both clinical trial patients and good manufacturing practice drug manufacturing, and its Glasgow, UK, biosafety testing site now has increased testing capacity.

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.

Smiths Detection has confirmed that the Bioflash air sampler can detect Beta, Gamma, Kappa, Delta, and Delta plus variants.

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.

NewAge Industries has completed a plant expansion that added new cleanrooms to its headquarters in Southampton, Pa.

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.

Under the terms of the contract, Meissner will expand its Camarillo, Calif., manufacturing site by adding additional cleanroom manufacturing space, executing advanced inventory management systems, and adding support areas to supplement capacity.

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.

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.

Mecart has achieved FM-4880 and FM-4882 certification of its cleanroom wall and ceiling panels from the FM Approvals certification organization.

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.