E. RODNEY LAX^1*, GUNNAR STÆRKÆR², PER MÖLLER², ALEKSANDER SWIETLOW¹, PETER LARSSON²,  BRANT ZELL¹
*Corresponding author
1. Business Development Consultant, PolyPeptide Laboratories Inc., 365 Maple Avenue, Torrance, CA 90503, USA
2. PolyPeptide Laboratories AB, Limhamnsvägen 108, 216 13 Limhamn, Sweden

Abstract

Peptide drugs are a growing class of innovative therapeutics with enormous economic potential for the pharmaceutical companies that market them. However, the contract manufacturing organizations (CMOs) that make the active pharmaceutical ingredients (APIs) face an increasing number of challenges from chemistry and downstream-processing, to changing cost structures, stricter GMP and regulatory compliance, as well sponsor-CMO interaction.
As a result,  the CMO world has seen significant attrition and loss of expertise.  To reverse this trend, sponsors, CMOs and regulatory authorities need to cooperate more closely together.

INTRODUCTION

This paper addresses some of the challenges the peptide therapeutic manufacturing industry confronts and those that it may face in the future. As guidelines continually tighten and sponsor expectations grow, more challenges can be expected. Many are controllable and recognizing them for what they are gives us a chance to address them rationally and hopefully achieve a satisfactory outcome.

A previous paper reviewed the status of the peptide therapeutic drugs, the peptide API industry and manufacturing technologies (1).

THE CHALLENGES

Consolidation of therapeutic peptide manufacturing industry

In spite of the healthy growth of the peptide therapeutic drug market, the industry - particularly at the CMO level - has faced an increasing number of challenges in recent years. Twenty years ago in 1996, there were about twenty CMOs that manufactured peptide therapeutics according to GMP. Today that number has shrunk to about ten, which roughly equates to losing 2 experienced CMOs and gaining 1 newcomer every 2 yea ...