Manufacturing, Aseptic Processing

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

Disposable equipment components find use in small-volume aseptic biopharmaceutical manufacturing.

A coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.

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.

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.

Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.

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

Through the adoption of single-use technology, drug manufacturers have been able to adapt to the challenges posed by the COVID-19 pandemic.

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

Material properties play a role in container closure integrity under frozen or cryogenic storage temperatures.

A best practices approach to pharma’s most challenging-to-inspect container.

The innovation of single-use technologies is applicable early on in the manufacturing process.

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.

While manufacturing increases have been implemented for vials and syringes, meeting future market needs remains unpredictable.

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

Cytiva acquired Vanrx Pharmasystems, a Canadian manufacturer of robotic aseptic filling equipment.

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

A holistic approach to validation and quality assurance is essential.

Apiject was approved for a $590-million loan from the US to build in-country capacity for COVID-19 vaccines and therapeutics.

Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.

Safeguarding against microbial contamination requires rapid detection and innovative technology.

The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.

Risk aversion is impeding the use of closed aseptic systems, and adding unnecessary cost and complexity to aseptic operations in the pharma industry.