• Discuss the desired goals and objectives of a new CMO, with an overview of the selection process
• Review the acceptance criteria for successful selection and tech transfer
• Specifically gain insight on the selection of a CMO for manufacturing HiPo DP, Low Volume Injectable
· Review the crucial make-or-buy question – what to outsource and what to do in-house?
· Discuss the benefits and risks of outsourcing, including the special challenges in outsourcing biologics
· Explore contract making to prevent pitfalls, and learn how to protect your IP
• Understand the difficulties for virtual companies at their early stage of growth, whilst they are devoid of any manufacturing capabilities, capacity and even internal expertise.
• Identify how CMO or CDMOs fill this gap and de-risk the virtual companies project and strategy
• Discuss guidelines to identify, select, contract and operationally work with CMOs
• Illustrate the positive synergies and identify high impact risks that should be avoided by reviewing brief case studies