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.
Made in Maryland: Emergent Featured on ABC2 News
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
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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
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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
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Project Quote
Project Quote
Then we will provide you with a detailed quote for review
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Quality Audit
Quality Audit
New client's quality groups visit us to familiarize themselves with our SOPs and systems during an audit
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Quote Acceptance
Quote Acceptance
You return the signed quote along with a purchase order for the quoted activities
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Project Initiation
Project Initiation
We update the project timeline, order the required materials, and host a kick-off meeting
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Development Work
Development Work
After providing detailed reports for all development studies, a master batch record for the product is created and approved
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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
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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