Product/Service

Drug Product CGMP Lyophilization Manufacturing Services

Source: Emergent BioSolutions Inc.

Drug Product CGMP Lyophilization Manufacturing Services

Emergent BioSolutions currently fills a number of lyophilized products in its two 240 ft2 lyophilizers.

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  • 60,000, 3 cc vials
  • 50,000, 5 cc vials
  • 40,000, 10 cc vials

Lot sizes for larger vials are smaller and depend on vial diameter to determine maximum capacity. Emergent BioSolutions has lyophilized syringe products of up to 120 tubs (100 syringes per tub)

Products that require lyophilization are filled, partially stoppered, and loaded into the pre-chilled lyophilizer throughout the filling period. Emergent BioSolutions has two filling machine options (low- or high- speed) to ensure that the time from formulation to lyo cycle start is appropriate and minimized where possible. The lyophilizer, with external condensers, has temperature control to as low as –65ºC and vacuum control between 50 and 1000 millitorr. A full load in the lyophilizer consists of 120 one-foot by two-foot trays.

Emergent BioSolutions can conduct turn-key lyophilization cycle development studies from design, implementation, and associated material characterization (i.e., FTIR, DSC and Freeze-Dry Microscopy). Elucidation and optimization of critical cycle parameters at the same CMO where clinical (and commercial) manufacturing will be conducted can significantly reduce timelines and maximize the probability of success for your lyophilized drug product.

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