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CMO

Contract Manufacturing Operations (CMO)

We have a proven track record as a world-class provider of contract manufacturing services for both bulk drug substances and sterile injectable drug products.

Our state-of-the-art single-use Bulk Drug Substance (BDS) facility enables turnkey upstream and downstream support for eukaryotic, microbial and viral expression. For sterile injectable drug products, our service offering includes vials and syringes; liquid and lyophilized products.

We currently produce more than 20 commercial products and have supported the development/manufacture of more than 200 clinical candidates for our clients.

Our facility has been inspected by multiple regulatory agencies worldwide, including the US, EU and Japan. See our Regulatory page for more details.

Bulk Drug Substance (BDS) Manufacturing

  • Clinical and Commercial Scale
  • Upstream and Downstream Processing
  • Single-Use Systems
  • Multiple Platform Technologies

Bulk Drug Substance (BDS) Manufacturing

  • Clinical and Commercial Scale
  • Upstream and Downstream Processing
  • Single-Use Systems
  • Multiple Platform Technologies

Fill / Finish Capabilities

  • Liquid and Lyophilized Products
  • Vials and Prefilled Syringes
  • Commercial Packaging: Labeling, Inspection, Distribution
  • Product and Stability Testing

Fill / Finish Capabilities

  • Liquid and Lyophilized Products
  • Vials and Prefilled Syringes
  • Commercial Packaging: Labeling, Inspection, Distribution
  • Product and Stability Testing

Start a Project: Process Steps

  1. Contact us

    Contact us

    The first step is getting in touch with us to review your project at a high level- you can use the web form below or give us a call

  2. Initial Paperwork

    Initial Paperwork

    Next we will put a "Confidential Disclosure Agreement" in place and ask you to fill out a "Product Information Request" detailing the anticipated work

  3. Project Quote

    Project Quote

    Then we will provide you with a detailed quote for review

  4. Quality Audit

    Quality Audit

    New client's quality groups visit us to familiarize themselves with our SOPs and systems during an audit

  5. Quote Acceptance

    Quote Acceptance

    You return the signed quote along with a purchase order for the quoted activities

  6. Project Initiation

    Project Initiation

    We update the project timeline, order the required materials, and host a kick-off meeting

  7. Development Work

    Development Work

    After providing detailed reports for all development studies, a master batch record for the product is created and approved

  8. Manufacturing

    Manufacturing

    We execute the production batch record at this point, and you are welcome to be on-site or view production activities remotely by streaming video

  9. Release

    Release

    We target 30 days from manufacture completion to release most products and will provide you with a complete copy of the executed production batch record (including a Certificate of Analysis) at that time

Meet Us

  • BioProcess International Conference & Exposition West 2017February 27— March 2, 2017Hilton San Francisco Union Square in San Francisco, CA Booth 207
  • DCAT WeekMarch 20— March 23, 2017Waldorf Astoria, New York, NY
    https://www.dcat.org/DCATWeek.htm
  • InterphexMarch 21— March 23, 2017Javits Center, New York, NY - Booth #1240

Interested in Starting a Project?

If you are interested in potentially starting a project with Emergent, want to find out more information about Emergent, or would like to have us contact you for any reason, please use this web form to send us information or questions, or call us toll free at 1-800-441-4225