Services

  1. Process Development: Mammalian, Bacteria And Yeast Based Success 2/17/2022

    At AGC Biologics, we have developed over 200 mammalian, bacteria and yeast-based processes, giving us the insight necessary to identify and optimize process parameters that are critical for achieving a high-quality, cost-effective manufacturing process.

  2. cGMP Aseptic Manufacturing And Sterile Fill-Finish 1/28/2022

    Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.

  3. Cell Therapy Capabilities 12/23/2021

    AGC Biologics develops and manufactures diverse cell therapies including CD34+ hematopoietic stem cells, autologous and allogenic T-cells, and NK cells. Our cell therapy capabilities cover numerous technologies, ranging from closed to open systems at different scales, depending on client needs.

  4. Viral & Gene Therapy Manufacturing CDMO Services 6/15/2021

    You’ve developed your viral vector gene therapy and now it’s time to embark on the voyage to manufacturing. But gene therapy production is uncharted territory, and you need someone to help navigate through the process. We can help.

  5. Pharmaceutical Commissioning & Qualification Services 12/21/2020

    We set the industry standard when it comes to commissioning and qualification project delivery.

  6. Tech Transfer for Commercial and Development 11/24/2020

    Regardless of where your promising drug product is in the development process, our experienced team at Pii will seamlessly transfer the results of your efforts into our hands and quickly get to work advancing it to the next phase.

  7. Lyophilization 11/24/2020

    Developing an effective lyophilization cycle is both art and science. Our skilled, experienced team of professionals, using Millrock lyophilization technology, provide critical synergies between the development lab and manufacturing line, ensuring your outcomes are met on time with quality.

  8. Aseptic Fill/Finish 11/24/2020

    Our Pharmaceutics Know-How™ accelerates the development of parenteral formulations for clinical trials and improves your decision-making from concept to clinic and commercialization. We have the proven experience, modern equipment and facilities to develop and supply injectable products (IV, IM and SC) and formulations including:

  9. Process Development 4/7/2020

    Our expertise in technology transfer and scale up ensures that the final product will be suitable for large scale manufacture and commercialization. We can provide small-scale proof of concept prototype batches, manufacture clinical trial materials; perform scale up manufacturing and registration batch manufacturing as well as perform product transfer and validation services in preparation for Commercial Manufacturing

  10. Fareva Aseptic CDMO Services 10/27/2019

    Fareva offers a large range of aseptic CDMO services in their Valdepharm facility.