Exotic Capability Wanted!
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.
- 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
- 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