Managing the development
of the drug substance route
of synthesis and manufacturing
process for an innovative molecule
in the preclinical phase
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Description
The project involved the development of a manufacturing method for a drug substance that is a candidate for an innovative drug product. It included coordinating work with contract development and manufacturing organisations and ensuring quality standards were consistent with applicable U.S. FDA and EMA guidelines. The work’s first stage was developing a synthesis route on a laboratory scale, followed by initial process optimisation.
In the next step, the production scale was increased to pilot, and an initial control strategy for process parameters and product attributes was proposed. A batch of the drug substance was also manufactured to conduct the preclinical phase.
Key points
Contract negotiation
Route of synthesis
Analytical methods development
Preliminary drug substance specification
Stability study
Preformulation study
Technological documentation
Quality agreement
Chemistry, Manufacturing and Control (CMC)
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.
View more selected projects
We have a broad experience in problem solving pharmaceutical problems for diverse companies.
Drug product formulation development with the protection of intellectual property.
Scope of work:
Formulation developmentFeasibility study for the use of 3D printing in the drug product manufacturing
Scope of work:
Project managementModernisation of the formulation development laboratory and the pilot plant
Scope of work:
Manufacturing troubleshooting