Pharmaceutical Development and Manufacturing (aka CMC)

Welcome to the Pharmaceutical Development and Manufacturing (aka CMC) knowledge hub.

Any provider of Pharmaceutical Development and Manufacturing (aka CMC) services must adhere to the highest standards with respect to sourcing and provision. As a continuation of our successful Discovery Chemistry build, we have seen an increased focus on Pharmaceutical Development & Manufacturing (aka CMC) to guide value-based decisions from Discovery till First in Human and beyond. Scientist.com streamlines the sourcing of CMC services by reducing the administrative burden to enable greater focus on science without compromising the quality and compliance checks.

• API/DP specific test methods
• API Stress Testing Studies
• Drug Product Stability
• API manufacturing process development, tech transfer and validation
• Bulk Manufacturing
• Bi-specific Antibodies

• Drug Formulation
• GMP Synthesis
• Polymorph Screening
• Salt Form Selection
• Solubility Studies
• Monoclonal/Polyclonal Antibody Development

• Spray Drying
• Crystallization studies
• Advanced intermediates
• Excipients
• Key Starting Materials
• Protein Production

Within the CMC space, we support multiple CMC related requests per day placed by a range of biopharma clients. Within CMC, we support both Small & Large Molecules (Biologics), including proteins, antibodies and peptides as well as oligonucleotides and derivatives. Our clients include all therapeutic areas and modalities including gene and cell therapies. Through Scientist.com you are able to access hundreds of pre-contracted CMC suppliers without additional legal delays. Due to the more regulated nature of CMC outsourcing we have developed technical questionnaires covering technologies, innovation and capacity that can be viewed within a supplier's individual profile.

A bespoke IND Enabling Package solution is also available – for more information please visit IND Enabling Category Page

We have expanded our award-winning COMPLi solution to support sourcing of CMC services. As part of this expansion we have made available to suppliers and clients a Pharmaceutical Development & Manufacturing and Raw Materials RFI to enable a client to proactively assess a supplier based on a range of key areas including policies, procedures, training, data, etc.

To access the COMPLi RFI simply view a supplier’s profile.

We have successfully launched our pre-assessment program, VERIF.i^® for CMC. For more information on VERIF.i please visit https://www.scientist.com/verifi/