Pharmaceutical Technology Europe - September 2010 - (Page 12)

The benefits of outsourcing highly potent API manufacture The main advantage of outsourcing highly potent API (HPAPI) manufacture is that it eliminates the need to invest in expensive containment infrastructure, which can also be complex to engineer, install and maintain. The safe synthesis of HPAPIs requires expertise in chemistry and a rigorous approach to Environmental Health and Safety, but there are relatively few CMO organisations who offer this combination because of the high infrastructure costs and more stringent GMP requirements. In many cases, there is a broad reliance on external consultants to provide pharmacological and toxicological guidance, which contributes to the final categorisation of an API. Having in-house expertise in pharmacology and toxicology allows the outsourcing provider to identify the most appropriate infrastructure for a given process. In some cases, the best option may be to produce upstream, non-high potency steps using more conventional processes and infrastructure. This will minimise the number of steps run in containment and, consequently, reduce the cost of the overall process. In terms of planning, it is important to anticipate the needs of clients to ensure that appropriate resources are in place for future demands — whether for high potency products or not. If specific infrastructure is needed to support a project, this should be discussed well in advance with a client to ensure that demands on repeat projects can be met. There is also a more general trend for drugs to be active at lower dosages, with certain therapy areas seeing increasing numbers of highly potent drugs. This increase may eventually drive differentiation amongst providers of high potency development and manufacturing services due to increasing sensitivities about sharing high potency facilities across therapeutic classes. PTE Charlie Johnson Changing demands Despite the challenges of working with HPAPIs, there has been a significant increase in the number of companies marketing an ability to produce such products in recent years following the growth in innovation — particularly in the oncology R&D arena where many compounds are highly potent. However, many suppliers tend to operate at a very limited scale, despite the trend to increased HPAPI volume requirements as oncology compounds become more tolerable. Based on a contribution by Charlie Johnson, High Potency Business Manager at CARBOGEN AMCIS. To read the full version of this article, go to www.pharmtech.com/johnson www.dishmangroup.com 1 CONTENTS 9 THE RIGHT ASIAN PARTNER 3 SLOW CLIMB BACK 10 INDIAN PERSPECTIVE 6 FINANCIAL CRISIS 14 SUCCESSFUL RELATIONSHIPS 7 HOW TO COMPETE 16 READ MORE… http://www.pharmtech.com/johnson http://www.dishmangroup.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - September 2010

Parmaceutical Technology Europe: September 2010
Contents
Pharmaceutical Technology Europe Poll
Slow Climb Back
The effect of teh Financial Crisis on Outsourcing
How a CMO Can Compete In An Increasingly Competitive Market
How Responsible Should the Sponsor Be For The Outsourcing Provider's Success?
How to Identify the Right Partner in Asia-Pacific
The Indian Perspective
The Challenges of Outsourcing Early Development
The Benefits of Outsourcing Highly Potent API Manufacture
Managing an Outsourced Biologics Project
Successfully Managing CMO - Client Relationships
Making a CRO Project Run Smoothly

Pharmaceutical Technology Europe - September 2010