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.
Company Details
- Employees
- 1
- Founded
- -
- Address
- Downingtown, Pennsylvania 19335, Us
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- technopharmasphere.com
- HQ
- Downingtown, Pennsylvania
Technopharmasphere Questions
Technopharmasphere's website is technopharmasphere.com
Technopharmasphere's LinkedIn profile is https://www.linkedin.com/company/technopharmasphere-llc
Technopharmasphere has
1 employees.
View email and phone details for 1
employees at Technopharmasphere.
Technopharmasphere's industry is
Pharmaceutical Manufacturing
Technopharmasphere's top competitors are
Alphalyse,
Acuitas Therapeutics,
Aera Therapeutics,
Orion Therapeutics, Inc.,
Inside Therapeutics (Insidetx),
Bioknow,
Nanovation Therapeutics™,
Bristol Myers Squibb,
Nanophoria,
Allogene Therapeutics.
Technopharmasphere's categories are Pharmaceutical Manufacturing
Technopharmasphere's founding year is 2012
