Transactional Content Management

PRODUCTS

  • When AST came to the table on the design for our new fill-finish isolator, one of the first areas AST engineers wanted to address was the usability and accessibility of the isolator and corresponding operations. With our customers’ point of view in mind, we wanted to address specific points of friction routinely encountered by operators and closely examine whether those friction points were necessary.

    Does an isolator need to be ergonomically unfriendly to clean?

    Should simple mechanisms like isolator doors be challenging to engage? (As much as one can appreciate exercise, no one wants to do “arm day” in cleanroom coveralls).

    Does routine maintenance have to be time-consuming and laborious?

    Many of these factors are accepted as par for the course in aseptic fill-finish manufacturing. Our question was, why?

  • Our goal is to help your business succeed by working with you to streamline the FDA regulatory process. ProPharma’s team of science- based regulatory consultants commands an unparalleled breadth and depth of knowledge pertaining to FDA’s regulatory framework and can work with you to accomplish your business objectives.

  • A full range of in vivo and in vitro testing services that can be customized for your project’s needs to expedite preclinical development while maintaining a high quality standard.

  • End-to-end solutions for cGMP manufacturing across the entire cell and gene therapy product lifecycle.

  • Are you in need of an experienced and flexible GMP service provider that can assist you with the development and clinical manufacturing of your gene or cell therapy with expert CMC support?

WHITE PAPERS AND CASE STUDIES

NEWS