Pharmaceutical Technology Europe - September 2010 - (Page 13)

Managing an outsourced biologics project When working with biologics, the challenge for CDMOs is to maintain product integrity throughout development, as well as the subsequent transfer to manufacturing groups. The conventional approach, which involves segregated development and manufacturing functions, can lead to transfer risk, so it is essential to have integrated functions that have an in-depth understanding of the process requirements. Development, by its nature, is unpredictable. As such, the planning and co-ordination of multiple projects is complicated and schedules are often short-lived. In the first instance, it is important to have open and transparent communications with customers to facilitate shared decision-making. To be able to respond quickly to problems that arise, CDMOs must also build flexibility into their personnel, systems and capacity. Developing employees to work across development and manufacturing functions not only allows for the redirection of resource when one team represents a bottleneck, but also supports the development of processes that can be readily transferred to the GMP manufacturing facility. Meanwhile, the use of disposable manufacturing solutions, standardised equipment and materials where possible can reduce lead times and costs, and also enables the quick turnover of manufacturing campaigns. Simple things, such as the prompt turnaround of documentation by both parties can have a significant impact on the programme timelines. impact on the programme timelines. Equally, detailed study plans and study reports at each stage greatly assist in the progression and management of projects. As with all aspects of the programme, proactive project management both by the project manager and the joint project team is critical, as well as regular meetings and project updates. Finally, the importance of the management and selection of quality subcontractors and suppliers cannot be underestimated. PTE Based on a contribution by Tony Hitchcock, Head of Manufacturing Technologies at RecipharmCobra Bio. To read the full version of this article, go to www.pharmtech.com/hitchcock www.recipharm.com Tony Hitchcock Getting off to a good start Perhaps the most important step is to obtain an in-depth technical understanding of the programme before agreeing to budgets and timelines because these can only be realistically decided upon with detailed information about the project. At the outset, it is also important for both the CDMO and the customer to understand and buy-in to their respective deliverables. Simple things, such as the prompt turnaround of documentation by both parties can have a significant 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/hitchcock http://www.recipharm.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