InHouse Clinical Manufacturing Unit vs' CRO Opportunities and Challenges or Pros and Cons

1
In-House Clinical Manufacturing Unit vs. CRO
Opportunities and Challenges or Pros and Cons
Steven A. Jacobs, MBA, R.Ph. JJ PRD, LLC.
2
In-House Clinical Manufacturing Unit - Pros

• Better controls
• Better communication
• Comfort level with batch docs
• Documented training
• Known skill sets and levels of capability
• Faster release of product
• Clear prioritization for production

3
In-House Clinical Manufacturing Unit - Cons

• Less flexibility to handle surges in production
• Limited equipment trains
• Limited ability to lease or buy necessary
  equipment (Capital purchase procedures)
• Less flexibility in hiring temps/interims
• Less streamlined/greater bureaucracy
• Lengthy internal qualification timelines

4
CRO - Pros

• Highly flexible both with employees and hiring
• Vast equipment trains
• Multiple QA audits keep them on their toes
• Diverse experience makes them excellent process
  troubleshooters
• Depending on the size of the company, can enable
  one stop development (many abilities in one
  company solid dose, MDIs, patches, high
  potency capability, steroid, antibiotics,
  analytical development labs, etc.)

5
CRO - Cons

• Contractors rarely if ever say No
• Depending on the global location, high turnover
  rate due to overload and burn out
• Intellectual property issues depending upon
  country location
• Staffing issues due to global location (talent
  pool, travel per day EU, weekend work and OT)
• Contractors suffer from customer worship and
  dont quickly share the ugly truth of limitations
  or issues
• Communication challenges (on both sides)
• Fault avoidance due to edicts from senior mgmt

6
CRO Cons (Contd.)

• Project management skills vary from company to
  company and internally from PM to PM
• Prioritization challenges occur depending on
  projects contracted and cost of projects
• Documentation is not always clear and if the
  contractor changes it to suit the company
• Risk increases that the employees get confused
• Ergo, employees make mistakes in production, or
• Fill out documentation incorrectly
• Depending on the global location, high turnover
  rate due to burn out

7
CRO Cons (Contd.)

• Delays due to
• Tech transfers of specs and method development
• Master agreements take time to draw up and get
  signed
• With each contract over 1,000 a bidding process
  must take place with at least 2-3 RFPs
• The QA audit process and completion with follow
  up CAPAs (Corrective Actions/ Preventative
  Actions )