Emergent Drug Product

Drug Product

 

Clinical Manufacturing

Whether you’re looking for small volumes of material to continue your clinical trials, or large-scale production for a commercial therapy, Emergent will manufacture to support all phases of the product lifecycle.

  • Systems designed to minimize losses and maximize finished product volumes
  • Large selection of pre-qualified vials, stoppers, and syringes to reduce development and pre-production timelines
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Commercial Manufacturing

We currently fill over 40 commercial products for our customers with several more products pending approval.

Contracting with us for clinical and commercial manufacturing has several advantages:

  • Flexible fill lines supporting most major syringe sizes for your fill liquid or lyophilized product, with flex-fill expansion underway.
  • Commercial product distribution is secure with our worldwide distribution team. 
  • Large footprint for finished drug product packaging.
  • 20 years of commercial production experience supporting clients in securing approvals and in more than 70 countries, including approvals by the FDA, EMA, and PMDA, to assist your growth and scale-up opportunities as your product progresses.
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Drug Product cGMP Lyophilization

Emergent currently has two 240 square foot lyophilizers available for lot sizes of:

  • 60,000, 3cc vials
  • 50,000, 5cc vials
  • 40,000, 10cc vials
  • Up to 100 tubs (100 syringes per tub)

Turn-key lyophilization solutions:

  • Lyophilization cycle development studies from design, implementation, and associated material characterization (i.e., FTIR, DSC and Freeze-Dry Microscopy)
  • Save time. By having elucidation and optimization of critical cycle parameters at the same CDMO where clinical and commercial manufacturing will be conducted, your timelines are significantly reduced and the probability of success for your lyophilized drug product is maximized.
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Packaging

Over 3500 square feet includes individual areas for staging, packaging, bulk packaging and inspections.

Offering clinical and commercial packaging services including:

  • Fully automated cartoning and labeling equipment
  • Dedicated project staging areas with secured access
  • Upgraded HVAC RTUs for temperature/humidity control
  • 4ft dividing walls with pocket doors for product/activity segregation
  • Ability to bulk package and label products at the same time
  • 16 visual inspection stations
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Product Testing

Our Analytical Services (QC) Team can perform the following tests:

  • Identification testing on client supplied raw materials (API and excipients)
  • In-process testing sufficient to ensure bulk formulation is done correctly and other standard in process tests (pH, density, bioburden, etc. as appropriate)
  • Finished product testing as requested
  • HPLC, TOC, IR, Karl Fisher, Dionex IC, Viscosity, Dissolved Oxygen, UV, RI, GC, TLC, SVP, Osmolality, Compendial Raw Material Testing

Our Microbiology Team can perform an array of tests including:

  • Enhancement & Inhibition
  • Bioburden Method Qualification
  • Bacteriostasis/Fungistasis
  • Final Product Sterility
  • Endotoxin
  • Bioburden
  • Bulk Sterility
  • Stability Testing

Stability Testing

Validated chambers are in place and operating for ICH stability temperatures. Upon request, we can generate stability testing protocols and schedules, which are rigorously followed. We will also perform individual tests requested by clients to support stability programs run by clients in their facilities.

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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