AARON HEISS
Dr. Reddy’s Laboratories – Custom Pharmaceutical Services, New Jersey, USA

Abstract

High potency API (HPAPI) production is currently the fastest growing segment of the pharmaceutical market: the global market is predicted to double in value from approximately $9bn in 2011 to $18bn by 2018. The rising demand for drugs with increasing potencies is leading to a number of questions for manufacturing. This article reviews current trends and challenges for innovators and contract manufacturers involved in high potency production.

INTRODUCTION

High potency drugs attract considerable interest for their selectivity and effectiveness at lower doses, which can mean fewer side effects. An estimated 25 percent of drugs in development are of high potency, and the high potency API and cytotoxic (HPAPI) market value is expected to grow from $9.1bn in 2011 to $17.5bn by 2018, providing a robust CAGR of 9.9 percent (1, 2, 6). However, manufacturing and delivering HPAPIs to meet this rising demand can be challenging, due to the compounds' requirements for specialized facilities and handling that needs expert knowledge and capabilities, particularly when handling multiple types of HPAPIs (e.g. hormonally active compounds, cytotoxic materials). Many pharma companies are choosing to outsource HPAPI manufacturing and this is presenting new issues. These include coping with variable compound classification systems; manufacturing in dedicated vs multi-use facilities; and ensuring sufficient quality when limited by time and budget constraints.

WORKING WITH DIFFERENT COMPOUND CLASSIFICATION SYSTEMS
The increasing demand for high potency drugs has led to an increase in ...