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Enzymatic Wound Debridement: What's changed since the FDA's approval in 1965?

Robert McCarthy Ph.D.  (President, VitaCyte LLC)

Pass Type: VIP Attendee, Exhibitor, Expo & Conference, Matchmaking - Get your pass now!

Track: Drug Manufacturing

Vault Recording: TBD

What will you learn:

  • Collagenase is the primary active pharmaceutical ingredient (API) approved for topical enzymatic wound debridement, no change in this API since 1965
  • Recent research indicates how collagenase may accelerate wound healing
  • New manufacturing methods to prepare the collagenase API improves product purity and consistency at a reduced cost when compared to the collagenase APIs used in today’s products

The collagenase APIs contained in today’s wound debridement products were manufactured using 1960's knowledge and technology: salt precipitation of a bacterial culture supernatant followed by dialysis, then lyophilization. No changes have been made to these products because any material change to the manufacture of the collagenase API will require the performance of new clinical trials to demonstrate efficacy. Collagenase containing debridement ointments are manufactured by mixing lyophilized granules of Clostridium histolyticum collagenase into petrolatum jelly. This ointment is smeared on problematic wounds to accelerate wound healing. Recent reports indicate that collagenase generates collagen peptides that activate cells that are responsible for accelerating wound healing.

VitaCyte has developed a highly enriched preparation of C. histolyticum collagenase using current protein purification technologies. The purity of this enriched enzyme is comparable to that found in highly purified collagenase used for mammalian cell isolation. Minimal proteolytic degradation of VitaCyte’s collagenase API results in a product with higher potency and greater effectiveness, reducing the amount of product used for treatment. The collagenase manufacturing process is robust with 12 fermentations having nearly identical biochemical characteristics. The manufacture of this material is easily scaled to meet customer needs.

VitaCyte’s collagenase API is lyophilized in a USP excipient to protect enzyme activity during storage and to enable efficient compounding into any delivery vehicle or wound dressing. VitaCyte is one of several manufacturers that have the capability to manufacture a consistent collagenase API with high functional activity. Product consistency reflects the rigorous enzymatic and physico-chemical characterization performed on each lot of collagenase enzyme