Api Contractor

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					Success in API Sourcing Starts
BEFORE the Project Has Been

     Brian W. Scanlan.
     Cambridge Major Laboratories, Inc.
We’ve all been here before…..the customer
 “The monkeys have been ordered!!! The
monkeys have been ordered!!! Damn it the
    monkeys have been ordered!!!!!”

    ……..1995 quote from a famous sourcing specialist to an API contractor
One of the main sources of project delay is
   the lack of accurate information, or the
withholding of critical information, during the
            tech transfer process.
Sponsors…..don’t set your suppliers
         up for failure!

       Everyone loses……………
All roads start at the API. In drug
development, it is always on the
critical path. Conveying the right
 information is as important as
selection of the right contractor
     Elements of API Supply
•   Chemical route selection
•   Chemical process development
•   Analytical methods development
•   Supply of pre-clinical tox lots
•   Supply of early clinical batches (GMP)
•   Stability of API
•   Validation of process/methods
•   Drug Master File or CMC Section of NDA
•   Commercial API Supply
     The Message………..

Sponsors/suppliers must understand the scope
of the project to ensure the right information is
conveyed and surprises are kept to a minimum
 Considerations for compiling a
   good technical package
Understand what you will be asking for (scope)
Compile all CURRENT chemistry and
analytical information
  Detailed experimentals, lab notebooks, batch
  Any methods (HPLC, GC, etc) in their current,
  updated form
If none exist, provide any available literature
Hazard data, if available
 Considerations for compiling a
   good technical package
Understand your own goals for the work
   Full process development vs. “bang it out”
   GMP vs non-GMP
   Could be driven by budget or corporate milestones
Perform a gap analysis to determine if there’s any missing
   Always important to perform this before the work commences
If client is a virtual company, find reputable experts in
chemistry, analytical, and regulatory areas to help compile
the tech package
   Are consultants conservative or risk takers? May impact scope.
        How to Organize
     the Technical Package
Schematic of Chemical Sequence
Target of Project/Deliverables
   Required date(s)
   Specifications (if known)
List of Available Analytical Methods
Opportunities for Development
   Stepwise assessment
List of Required Report(s)
Safety Issues
Materials to be supplied by customer
Shipping Information
Suppliers…..pitfalls to watch for
   when receiving an RFP
RFP contains no relevant information, but client claims it
was produced already at reasonable scale
Each step of chemistry was performed on a different scale
(“mosaic chemistry”)
Only the procedures from a distant analog are shown
Procedure conveyed is eerily close to the published
patent/literature only at 100x the scale (“paper scale-ups”)
$/kg quote needed for 5000kg when all that exists is a 5
gram med chem prep.

   Be vigilant and ask a lot of questions or else……..
          This could happen to you!
Unhappy (big!) customer   Unlucky (weak) supplier
Or worse yet………….
            The Proposal Process;
        rules of engagement supplier/client

Don’t ask your supplier to do something you wouldn’t ask your own
people to do.
   hazards, timelines, scale jump (gms to tons??), etc.
“Paper scale ups” are taboo. You’ll set your supplier up for failure
Give ample time for analysis and draft of proposal….but not too much
time. (< 2 weeks)
The more complex the RFQ, the more iterative the proposal process
   Expect revisions and clarifications to scope
   Give the supplier the courtesy of explaining the proposal. They’ve spent
   significant time/effort writing it.
Let the experts on each side of the table talk
   Helps refine scope
   Gives sponsor an indication of level of suppliers expertise and vice versa.
 Now we know what information to

Who should the information be sent to?
Checklist for Contractor Selection

Referrals and Reputation are very important
  Compatibility of size/critical mass with phase of
  Compatibility of operating philosophies
Inspection History
Quality audit and Technical audit BEFORE
making the choice
Financial stability
Ownership structure
   Building Supplier Relationships
              Supplier      •   Culture and goals
             Evaluation     •   Strategic fit
                            •   Overall expertise
                            •   Services provided

              Supplier      • Specific expertise and previous experience
            Qualification   • General capabilities e.g. facilities
                              equipment, staff and workload
                            • Organization structure, staff turnover and
  Master                      affiliation
 Service                    • Financial stability
                            • Project management, communication and

              Supplier      • Audit of Quality systems
               Audit        • Tailored project audits
 Align your development and
manufacturing needs with the
capabilities of your contractor
Appropriately written proposals will
    specifically define scope,
  resources, timelines, and cost
  based on customer dialog and
        technical package
         Typical Early API Development Project
                    (assume 5 step process, no process/analytical validation)

Milestone                 Material to be used for:         Typical        timing      Price Indication

Route Scouting/           Initial tox screening or other   grams          Weeks       $25K-$50K
Chemistry Evaluation      non-GMP use                                     1-6

Process                   Tox / formulation                10’s – 100’s   Weeks       $50K-$75K
Development               development                      of grams       4-10

Analytical                Int. methods / API methods                      Weeks       $35K-$50K
Development               Stability indicating method                     1-10
                          Ref stds
Demonstration Batch       GLP tox studies, formulation     100’s of       Weeks       $75K-$150K
                          development                      grams to       10-16
                                                           few kilos
GMP Campaign              Phase 1-2                        1-10 kilos     Weeks       $175K-$400K

Stability Studies         With material from GMP                          2-3 years   $30K-$50K

Total                                                      ~1-10 kilos    5-6         ~$400K-$775K
More speculative projects (i.e.
sparse technical package), require
more milestone-based approach.

Be specific with achievable
milestones and communicate
Follow these rules and you’ll get off to a
              great start.
          i !!
  G   an

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