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Peptide manufacturing scale-up: an emerging biotech prospective

corresponding

BRUCE H MORIMOTO1, ALISTAIR J STEWART2
1. Cerecin, Inc USA
2. AJS Life Sciences Consulting Inc., Canada

Abstract

Peptides are often potent and highly selective for their targets, thereby attractive therapeutic modalities for the emerging biotech company to rapidly enter clinical development. Davunetide is a neuroprotective peptide previously in development for the treatment of Progressive Supranuclear Palsy (PSP), an orphan movement disorder. The accelerated development timeline required backend loading of many manufacturing activities including considerations for large scale peptide synthesis. Davunetide will be used as a case study for the transition from solid-phase to liquid-phase peptide synthesis.


INTRODUCTION

Peptides represent an elegant therapeutic modality in that they typically have a high degree of specificity and potency.  To date, over 60 peptides have been approved with a steady increase over the past 40 years.  Peptides are not typically metabolized by the cytochrome P450 enzymes; therefore, have a low potential for adverse drug-drug interactions.  

This is particularly attractive for therapeutic indications in which the patient may be taking numerous drugs for multiple co-morbidities.

 

From a manufacturing perspective, the chemistry of solid-phase peptide synthesis has greatly simplified synthesis of small milligram quantities, sufficient for drug discovery and lead optimization activities. However, as a drug progresses toward the clinic, the peptide Active Pharmaceutical Ingredient (API) requirements need to transition in both scale and quality/control.

 

The smaller or emerging biotech company is under constant pressure to do more with less.


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