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. 

TechnoPharmaSphere

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TechnoPharmaSphere

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