Technopharmasphere

Global Industrial Experts in Chemical Manufacturing & Controls (CMC). Biopharm and Small Molecules. Early and Late Stage Product Development. Strong Science & Significant Industrial Experience Services Analytical & biophysical methods development and qualification. Sample testing, data analysis and results interpretation. Product's characterization, comparability, SFRs & CQAs determination. cell culture & purification process development support. Pre-formulation screening, formulation & device development. Tech transfer for processes and analytical methods. Manufacturing & QBD support. Regulatory support IND/IMPD, IB, Pre-IND in USA, Europe, and MENA. Compliance systems in USA, Europe, and MENA. CRO/CDMO/CMO evaluation and management. Due diligence, asset licensing and business partnerships. IP & patent data evaluation, drafting, and expert witness. Technology development. PET imaging clinical studies. Project, alliance, and supply chain management. Technical writing. Contributions & Achievements 7 BLA/MAA for marketed products. 15 IND/IMPD for products moved into clinical development. led entire CMC of 3 clinical trials of Zr89-labeled biopharm. 20+ published peer reviewed articles and 3 clinical reports. 2 patents, mAb structure with higher potency and light liquid formulation for biopharm products. Guidance for ways of working on product's SFRs including in vivo and CQAs determination. Volunteer Achievements Co-founder of the HOS of Protein Therapeutics Symp. Co-founder of the BWG. Reviewer for scientific peer reviewed journals. Reviewer for grant proposal funding agencies. Mentor for students and professionals. Specialties: Vaccines and therapeutics ranging from recombinant proteins, biosimilars, biobetter, mAbs, dAbs, fusion proteins, bispecifics, gene therapy, RNA, CGT, ADC, multi-valent protein/peptide complexes, plasma derived proteins, liposomes, nanoparticles, and small molecules.