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 CaSSS HOS of Protein Therapeutics Symp.  Co-founder of the CaSSS 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.