Program Partnering

Beyond our tailored analytic programs, ProtaGene’s clients can benefit from even more broadly integrated partnerships. We structure these relationships to best meet our clients’ needs, typically as strategic program partnering through our Customized-Candidate Analytical Development (C-CAD) partnerships.

Focused Development Expertise When You Need It Most

ProtaGene strategic engagements are custom-designed for clients looking for strategic guidance through specific stages of development.

If you would benefit from higher-level strategic partnership, ProtaGene’s senior leadership team is here to help.


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C-CAD Takes Analytical Partnership to New Levels

Rather than a trouble shooting or routine project,ProtaGene’s Customized-Candidate Analytical Development (C-CAD) is a unique partnership program structure for designing, implementing, and delivering full analytic programs through all stages of development. The relationship goes well beyond analytical services and brings the highest level of strategy, coordination, and execution to your molecule’s development.

C-CAD is a multi-stage journey for which ProtaGene engages with full responsibility and close coordination with your team in moving your molecule along its life cycle journey.

Why C-CAD? Biopharmaceutical pipelines have become considerably more extensive, and therapeutics have become more complex and diverse. Biotherapeutic companies increasingly find themselves needing to acquire or develop an asset within a therapeutic class in which they have limited experience. Or perhaps the client’s business model is simply virtual in nature. In either scenario, ProtaGene’s expertise and the C-CAD program progress your molecule from candidate to the market.

Comprehensive Partnership and Coordination of Operational Activities

C-CAD is an advanced collaboration workflow in which ProtaGene accepts responsibility for the molecule’s journey.

CMC Molecule Management is Key to Your Success

Our C-CAD CMC Molecule Manger provides:

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    Professional expertise encompassing drug development by stage

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    Strong technical background and molecule knowledge

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    Forward-thinking ethos and in-depth regulatory expertise

With the objective of successfully delivering the therapeutic to market at the forefront of the relationship, the coordination of operational and analytical activities strongly relies on:

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    Active and regular communication about results, adjustments, and interim goals between partners

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    Systematic masterminding of sample shipment between project associates

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    Transparent budget monitoring and control

C-CAD Program Navigates Your Molecule from Clone to Clinic

Phase-appropriate analytical modules are customized for every stage of your molecule’s development journey. Your CMC Molecule Manager assures that knowledge and insights accumulated throughout the development journey are applied at every stage and utilized to address challenges that arise as a therapeutic is making its way to market.

Lead Candidate Selection Clone Decision Poolphase Initial Process Development Non-GMP Production C-CAD Candidate C-CAD Clinic Final Candidate C-CAD Approval CMC Package for Initiation of Phase 3 C-CAD Market CMC Package for MAA/BLA GMP Production Phase 3 Phase 1/2 Upscale MAA/BLA PPQ Commercial GMP Production Cont. Process Verification CMC Molecule Management CMC Molecule Management CMC Molecule Management Analytical Development Analytical Development Analytical Development Method Development Method Performance Verification Support of Process Development Forced Degradation Study DS Development DP Development Developability Clone Selection Analytical Target Profile Early Formulation Development Tox Batch Release and Characterization Method Validation Phase 1/2 Tox Batch Release and Characterization Process related Impurity Testing Stability Studies non-GMP Release/Characterization/ Comparability Stability Studies Phase 1/2 Release/Characterization/ Comparability Support of final formulation and DP development Phase 3 method validation Final release Specification Process Validation Support Impurity Testing (process, product) GMP Batch Phase 3 Release and Characterization Qualification of Ref.Std Stability Studies Phase 3 and submission Method Transfer to commercial Extractables/Leachables Release/Characterization/ Comparability Analytical lifecycle management Method transfer to other sites Method transfer to other sites Backup Release and Characterization Ongoing Stability Studies Market Supply and Commercialization Pre-clinical Clinical Phase 1 and Phase 2 Clinical Phase 3 Approval Market Research & Early Development C-CAD Candidate Final Candidate C-CAD Approval C-CAD Market CMC Package for MAA/BLA C-CAD Clinic CMC Package for Initiation of Phase 3

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