Larka

Exotic Capabilities

Customer Experience - Biopharma company intended to contract out manufacturing from of a very specific product consisting of two cartridges.

 
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Exotic Capability Wanted!

Context

Biopharma company intended to contract out manufacturing from phase 1 to phase 3 - and hopefully commercial – of a very specific product consisting of two cartridges: one with lyophilised product and another one with diluent. This biopharma company requested Larka to identify potential CDMO partners in Europe and North America.

Company Profile

  • Swiss company
  • 2,500+ employees
  • Over 2bn CHF revenue
  • 10 marketed products & more than15 in development

Larka's Scope Of Intervention

Larka's project management team covered the following tasks:

  • Preliminary Preparation
    • Project & requirements analysis
    • Distinction between mandatory and scoring requirements
    • Selection criteria definition
    • RFI drafting
  • CDMO identification & qualification
    • Preliminary screening - approx. 70 CDMOs selected for lyo cartridges criteria
    • Systematic contact of each of these CDMOs
    • CDMO qualification based on information shared by executives
    • Preliminary list of suitable CDMOs
  • Data Collection & Analysis
    • CDAs process management - when required
    • RFIs process management
    • Double-check of information shared into RFIs collected
    • Questions/Answers round with CDMOs
    • Shorlisting of CDMOs
  • Data Consolidation & Final Report Drafting including
    • Mission overview - methodology, number of CDMOs approached, etc.
    • Detailed profiles of potential partners - legal status, headcount, turnover, POC, plant location, certifications, capabilities & capacities, special manufacturing or containment capabilities, future CAPEX, etc.
    • Larka comments and recommendations

Conclusion

  • Lyophilised cartridges was a very hard to find capability, especially because required volumes were important for commercial scale up
  • Larka managed to provide biopharma company with several potential partners based in the US and in France
  • One month after the delivery of Larka’s final report, the biopharma company entered into discussion with 2 CDMOs and could start a new collaboration with one of them three months later