Market Challenge: Peptide based pharmaceuticals are commercially produced using 30 year old solution/solid phase chemistry or a hybrid approach. Both methods are far from ideal suffering from high cost of purification, low yields and low overall efficiency, long development times, varying quality, and high volumes of waste. The desired purity is achieved by repeated purifications – the antithesis of Quality by Design.
Solution: EnzyPep has developed a proprietary selective peptide fragment coupling technique which permits generation of products at 30-70% lower cost, in higher purity, in higher yield, and in a sustainable way (up to 80% less organic solvent consumption). The new approach accords perfectly with the modern regulatory drive towards QbD, to the extent that it may potentially set new expectations for all pharmaceutical peptides.
Offer 1: Enzypep can offer a license for single compounds or a family of compounds.
This can be used for generic or branded compounds.
Effectively your company can produce the selected compound via the Enzypep IP. The license can be exclusive therefore limiting the amount of producers to manufacture the compound worldwide.
Enzypep will show proof of concept on tens of gram scale providing all info to you. Also we will assist in the technical transfer and the actual scale up of the technology at your or a selected vendor site.
The enzymes required to use the IP will be provided by Enzypep at cost price.
Offer 2: Focus is NCEs (new chemical entities).
Enzypep will provide you a custom made quotation. In highlights:
a) Initial feasibility screen (free of charge).
b) 1-5 gram of product to be produced by Enzypep or FDA approved partner.
c) The ability to use the Enzypep technology for 18 months against a fixed license fee.
d) Enzypep will optimize the enzyme tailored to your product at a fixed price
e) cGMP production of x grams and use of Enzypep IP against fixed price.
f) Process validation work incl. analytical method development and validation.
g) Submission and regulatory support.