PEPTICHEM

CMC Platform

  • Customer objective

  • Reduce CMC risk

  • Resolve critical technical issue

  • Prepare new funding round

  • Better prepare IND

  • Specific actions

  • Technical Dossier and CMC Strategy Review

  • Risk and Gap Identification

  • Prioritised action roadmap

01

CMC Gap Analysis

Detailed report on the gaps and shortcomings in the CMC strategy.

02

Risk matrix

Identification and prioritisation of technical and regulatory risks.

03

Recommendations and schedule

Technical recommendations with a prioritised action calendar

Real-life cases

Illustrative examples of how PEPTICHEM intervenes to accelerate drug development and reduce risks in CMC strategy.

Unlocked IND
para StartUp Biotech

  • SituationStartup in the pre-clinical phase with quality issue in an API that prevented the presentation of the IND

  • ActionProblem analysis, critical point identification, Process improvement proposals and implementation monitoring at the CRO existing

  • ResultIND unlocked in 3 months and the possibility of a new investment round.

Risk reduction
CMC pre-investment

  • SituationBiotech in Ronda with investors technical CMC due diligence

  • Action: Completed CMC Gap Analysis and Risk Matrix with recommendations for each identified gap and implementation proposals with In-house Teams.
  • ResultDue diligence passed in Deadline. Round successfully closed.

Problem-solving
critical technician in an API

  • SituationCompany with a return on synthesis below 40% in a product that will become KEY in its pipeline.

  • ActionReview of the synthesis protocol, identification of the critical step, and optimisation of reaction and purification conditions.

  • ResultIncreased performance in a 78%. Production unlocked in 15 weeks.

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