As Injectables Become More Complex, Filling Lines Must Become ...
Traditional equipment utilized in the manufacturing and filling of drug products at commercial scale is primarily suited to the production of tens of millions of doses or more per year. However, the use of such systems with complex or low-volume drug products can be unfeasible due to their inflexible design configuration or cost inefficiencies.
Shot of a Lifetime: How Two Pfizer Manufacturing Plants ...
“Adding flexibility and increasing volume has been key. Meanwhile, we continued to manufacture our more than 400 million units of other vaccines and injectables per year, for millions of patients around the world,” underlines Van Steenwinkel. The task is herculean. And the work has been as memorable as anything could be.
Blow-Fill-Seal technology in Large Volume Parenteral Packaging
dedicated to pharma packaging. Key features: -1- Advanced Aseptic Processing*. -2- Hygienic design. -3- Ultra-Compact A-Zone 500 x 200 mm. -4- Production capacity (e.g. 250 ml, PP): from 2000 pcs /h (bp 321, 8 fold); 12 mio/a up to 8800 pcs /h (bp 364, 14 fold); 52 mio/a.
Critical Components for Vaccine Manufacturing - Globally ...
Producing large amounts of a vaccine in a short period of time entails more than developing the proper biological construct—such as a candidate vaccine virus, recombinant antigen, or mRNA—as quickly as possible. After a new vaccine is designed and shown to be safe and effective, the main challenge that manufacturers face is scaling production. A manufacturing plant may require about ...
Early-Stage Considerations for the Manufacture and Delivery ...
In-house manufacture may require investment in new capacity for a dedicated line for mass production of a single product or a flexible filling operation that can handle multiple products and different size vials. Flexible capacity has been crucial in the current efforts to fill COVID-19 vaccines. Different drug containment solutions for vaccines
Considering Blow-Fill-Seal for Biologic Drugs - PharmTech
In addition, in December 2021, French CDMO Fareva and ApiJect announced a 10-year licensing agreement to install BFS production lines with the capacity to fill/finish 500 million doses per year of vaccines and other large-molecule injectable drugs with ApiJect’s technology (6).
Fill/Finish of Vaccines and Therapeutics - PharmTech
All Hands on Deck for Fill/Finish of Vaccines and Therapeutics. Pharmaceutical Technology, Pharmaceutical Technology-08-01-2020, Volume 2020 Supplement, Issue 3. Outsourcing partners provide capacity and tech transfer expertise in the pharmaceutical industry response to the COVID-19 pandemic. As the biopharmaceutical industry races ahead with ...
Full article: A Comprehensive Design Approach for Injectable ...
Two liquid vial products and one lyophilized vial product are manufactured in one production line. The annual demand changes as shown in Figure 5 (a). Similar curves were used in the previous studies (e.g., Matsunami et al. Citation 2018; Yamada et al. Citation 2022) that considered the patent cliff of drug products.
Vaccine manufacturing - PMC - National Center for ...
This chapter outlines the basics of manufacturing a vaccine and a description of some examples of currently licensed products. It then moves to the regulatory requirements for vaccine manufacturing including cGMP compliance and then discusses the development of new vaccines.
Allowable Excess Volume and Labeled Vial Fill Size in ...
19 thinking on allowable excess volume and labeled vial fill size in injectable drug and biological 20 products. It replaces the draft of the same name that was published on March 14, 2014 (79 FR
Contact Us Now