Each project is structured to meet the needs of the client company and costed accordingly. However, typically a project might proceed as follows:

Phase I – requirements for Clinical Trials (CT) Transfer of a selected lead formulation to pilot scale or larger equipment. Manufacturing trials to define process parameters, cleaning verification, etc. with a further analytical program which could cover drug potency/purity, content uniformity, dissolution testing, drug crystallinity including analytical method validation.
As a next step we could go forward with manufacturing a pre-batch based on manufacturing process and formulation composition.
The pre- batch provides the supportive data which are necessary for finalization of the manufacturing instructions  needed for CT manufacturing. Preparation of batch records and manufacturing of the clinical batch itself is generally performed meeting current GMP standards.

CT samples can be provided to our customers as either bulk material or fully packaged material for the clinical studies, together with the required stability testing, clinical lot validation and release testing by Quality Control.
Our team could also help you in compiling the Investigational Medical Product Dossier (IMPD) and Investigational New Drug (IND) Application.
Following successful results of the Phase I (or Proof of Concept) study we would start with up-scaling the manufacturing process in pilot-plant scale (usual batch size 25-100 kg) or production scale (> 100 kg) including samples for Phase II/III studies.

 

 

Phase I Scale-up for clinical trial batches (phases II and III)
The development trials support the characterization of the manufacturing process and define any critical processing parameters These data would provide the basis for further scale-up and necessary adjustments (SUPAC – Scale-Up & Post Approval Changes).

 

In the subsequent Development Phase the process parameters will be defined for manufacturing instruction , for the production for registration batches. Long-term stability data will be generated based on the registration batches.

• · Registration batches would be manufactured on production-scale equipment and the results summarized in a Development Report.
•     ·  Finalization of process parameters for full-scale production prior to manufacture of validation batches and subsequent market supply.