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Area of Interest:
Process development
Pre-GMP material production
GMP Cell-banking
GMP Viral Vector Production
GMP Cell Production
Sterile Fill and Finish
Quality Control and Quality Assurance Services
Regulatory Affairs Services
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The general process of getting a project price quote or proposal to the start of the activities is described below:

Defining your project

1. Contact MolMed GMP Solutions with a potential project.

2. Discussion to determine if our capabilities and schedule are a fit for your project needs and timeline.

3. Enter into optional non-disclosure (confidentiality) agreement.

4. Send us a Request for Proposal (RFP) detailing type of material, foreseen GMP reagents, scope of work and timeline for your project.

In the RFP Please provide as much detail as possible about:

• the cell line to be manipulated (source, identity, safety etc.);

• any raw materials, solutions or media to be used (GMP or not);

• growth conditions of the cell line;

• manufacturing or filling processes;

• characterization tests required;

• storage and shipping requirements;

• documentation for Regulatory Authorities required.

Developing your Project

1. Conference call to discuss project specifics to so that MolMed can prepare an estimated pricing proposal.

2. Detailed pricing proposal generated, reviewed and if accepted, your space in our facility is secured.

3. Site audit for sponsor to evaluate facility, quality systems and staff (recommended).

4. Project kickoff meeting held to finalize specifics for initial Tech Transfer from Customer to MolMed staff.

5. Document preparation for the manufacturing process begins.