Transactiva develops the whole platform of drug production in a plant, including the downstream process, in view of the final product registration by the industrial sponsor. To simplify the process of technological transfer to industry and to promote the industrial development of its projects, the company performs a range of assays on materials and procedure s at a lab-scale for the complete characterization of the pharmaceutical protein and the definition of the best conditions in terms of final purity, homogeneity and pharmacological activity of the drug. Every phase of the downstream process is conceived to be industrially scalable and easily transposable to GMP. Transactiva knows the regulatory aspects involved in the extraction and purification of pharmaceutical proteins from plant tissues and has already some direct experience on this subject, gained with the collaboration with industrial partners.
Transactiva has the equipment and the skills needed to extract and purify small batches of the molecules of its pipeline; these lots are used in preclinical studies concerning the biochemical, structural and pharmacological characterization of the molecules.
Typically, Transactiva develops a downstream process according to the following path:
- the analytical methods necessary for process control are established first. This activity is carried out in compliance with the ICH Q 2 (R1) and the ICH Q 6 B guidelines concerning the validation of analytical procedures and the specification of biotechnological products, respectively.
- equipment and materials for downstream process development are chosen in order to achieve GMP-transposable and industrially-scalable results. Protein extracts are processed on a GMP-compatible direct filtration system from Pall® or cross-flow filtrated with the Qstand bench equipment from GE. The chromatographic platform is based on a UPC-100 ÄktaPurifier system equipped with several optional ÄktaDesign components. The stationary phases for chromatography are mainly chosen from GE Bioprocess products.
- The development is set up according to the ICH Q11 guideline, with particular attention to the critical quality attributes of the drug substance and the process control strategy.