Education Session

407 - Current Outsourcing Trends in Bio-contract Manufacturing: The Impact on Pharmaceutical Engineers’ Productivity and Job Security

Get Agenda 10 November 14.15-17.15
ISPE CEUs: 0.25

Tracks: SurvivalSupplyProduction

This session explores current trends and shifts in contract manufacturing for biopharmaceutical products, and how these shifts have created pressures and uncertainty for pharmaceutical engineers. Will shifts in outsourcing today create domestic job loss? According to the 6th Annual Report and Survey of Biopharmaceutical Manufacturing, demands for improved downstream purification are reaching critical levels, as manufacturing strategists and suppliers try to cope with rapidly increasing upstream capacity, general cost-cutting, and broad demands for pricing reform. This highly interactive presentation will review how pharmaceutical engineers, designers and vendors are dealing with these unprecedented events. The session will involve substantial audience participation as pharmaceutical operating company engineers define their expectations of their CMOs, and as CMOs define the more closely integrated relationships they need to establish with their clients. The outcome of the session will be a summary White Paper, including expert commentary, to be shared with meeting participants.

The current global budget climate has created significant shifts in how biopharmaceutical companies are outsourcing new projects. Expert panelists will discuss how economics are playing a greater role in the strategic outsourcing decisions. This session will cover trends found in this global study, and the panel will evaluate options for managing decision-making in the current economic environment. Coverage will include: Current industry capacity utilization and five-year trends; Differences in expectations between U.S. vs. Western European manufacturers; Current range of titres for MAb production; Current capacity constraints and trends; Expected capacity constraints by 2013; Factors creating future capacity constraints; Key areas to address; Capacity expansion plans; Current outsourcing, by production system; Critical outsourcing issues; Trends in selecting a CMO; and Difficulty in finding a CMO.

How you will Benefit

At the end of this session, participants will be able to:

  • Effectively determine the best approach to outsourcing for their organization
  • CMOs will better understand their clients explicit concerns and problems
  • Assess how current trends may affect participants’ organizations
  • Describe which countries are attracting the most outsourcing and why
  • Understand current trends in outsourcing and how to manage these shifts
  • Implement an outsourcing strategy based on current and future projected economic factors

Who Should Attend

Directors and managers of technology, downstream purification, operations, manufacturing, and facility design. Engineers, process development directors, and scientists, and clinical and commercial manufacturing staff. Staff at CMOs and Biotherapeutic developers involved in outsourcing decisions.

ISPE Communities of Practice (COPs)

Biotech, Disposables, ESB, PPD, PM, and SPP

View the ISPE Community of Practice (COP) Guide

Session Leader

  • Eric Langer, President & Managing Partner, BioPlan Associates, Inc. USA

Session Presenters

  • Jayant Lakshmikanthan, McKinsey & Company
  • Ian Sellick, Director of Marketing, Pall Life Sciences USA
  • Lei Sun, Ph.D., President of Manufacture, AutekBio (Beijing), Inc. China
  • Rodney Thompson, President, BioPharm Process Associates USA

Annual Meeting Sponsors