WP1 – Process development of TA101 in cGMP conditions
Objectives: i) Select best vector-host expression system for production of TA101 (QB and subcontractor ART); ii) Optimize fermentation process for TA101; iii) Optimize purification process for TA101; iv) Study stability profile of TA101 upon process development; v) Provide analytical methods accessory to the production process; vi) Provide all documentation related to the production process to support the transfer to the manufacturer of the clinical materials.
Expected result: The production process for TA101 in conditions for delivery into humans will be optimized. The process will determine the best host system for the production of TA101 and will also determine the optimized process for purification of TA101.
WP2 – Clinical research of Phase I
Objectives: i) Determine the safety profile of TA101 for therapeutic use in humans, including PK/PD data; ii) Determine the safe dose of administration of TA101 to be used in Phase II clinical studies after the end of TA101-GOCLIN project.
Expected result: This clinical phase I study will determine the safe dose of administration of TA101 into humans. This set of data will put TA101 on a track into a Phase II study and will add much value to the product.
WP3 – Development of a medical device for the optimal administration of TA101 (micro-needle patches)
Objectives: i) To optimize a medical device capable of providing efficient administration of TA101 to patients; ii) To select the best possible array design for clinical application of TA101 tailoring the dimensions of the Microneedle array, e.g. needle length and width, number of needles per array, and positioning on the array); iii) To select the best conditions (a.o. solvent) to load the single domain antibody (TA101) on the arrays; iv) Provide npMNA devices loaded with TA101 for POC in animals. 5. Develop a prototype of the integrated array-patch device with appropriate loading capacity; v) Test the physico-chemical properties of the loaded array patch devices.
Expected result: A microneedle patch will be developed as a device specifically suited for the painless administration of small domain antibodies. This innovative system will be key for the differentiation of small domain antibody delivery into humans.
WP4 – Dissemination and training
Objectives: i) Provide dissemination of the project results in industry conferences and also to the public; ii) To give to TA101-GOCLIN scientists timely updates and information of project results to assure continuous follow up of project achievement among partner SMEs.
Expected results: Broad dissemination of results and training.
WP5 – IP management
Objectives: i) To assure that valuable information arising from the project results is protected in terms of intellectual property.
WP6 – Project management
Objectives: i) To obtain a base of structured practices to maintain streamlined activities within the Consortium; ii) To give to all partners timely updates and information of project results and assure timely follow-up of project deliverables and milestones.