R&D and Custom Synthesis
Although ACS Dobfar is a Chemical Pharmaceutical Company with its own Production Lines, it can be also considered as a “Custom Synthesis Partner”: for exemple R&D works on Custom Project for the production of new candidates for clinical trials.
Our pilot-plant facilities can produce new drugs having the same purity level and
impurity profile achievable in a laboratory setting in quantities (up to 100 kilograms)
to satisfy clinical studies.
As we are used to new process / product development with the goal of industrial production in multi-ton quantities, we follow a similar approach to the development of new processes for our “partners”. The scale-up for the first hundred kilograms or tons usually requires just optimisation, with minor changes, in the laboratory process used for the first kilogram.
For custom projects, the R&D department offers a well structured approach, working closely with other departments to get the best result for the customer:
- combination of biocatalysis and chemical process research
- fermentation processes and downstream purification
- industrial raw material evaluation
- skilled people that develop lab processes and take care of the plant scale-up until quality and yields meet the target
- sterile plants
- process supervision by the Quality Assurance dept.
- Regulatory Affair assistance
- Drug Master File compilation
Advantages for the Customer
- We are able to speed up the chemical product development, by obtaining a single process scalable up to the commercial quantities; The use of industrial protocols and raw materials coming from the industrial production makes our calculation reliable.
- An easier registration procedure for clinical candidates is possible as we can supply industrial products with the same impurity profile of those used in clinical trials.
Custom Synthesis Project Life
1) CONTRACT RESEARCH ORGANIZATION (CRO)
- Process development from discovery process to commercial supply process
- Analytical development
- Impurity characterization
- Pre-clinical and Clinical supply manufacturing
2) CONTRACT MANUFACTURING OUTSOURCING (CMO)
- Process validation
- Commercial supply manufacturing
- Right of first refusal should be included in Master Service Agreement signed
at the beginning of the project
