GMP Peptide & Dye Facility Enhancements
AnaSpec’s GMP manufacturing facilities have expanded through the addition of downstream work areas at our Fremont, California campus.
Our highly controlled and segregated Certified ISO 7 cleanrooms mitigate any potential risk of cross-contamination. These improvements ensure higher product quality, and quicker manufacturing turn-around times.
Our GMP grade products are compliant with applicable parts of 21 CFR 210 and 211 and 21 CFR part 820 and ISO 13485, and are governed by our distinguished Quality Management System (QMS).
Our services feature the following:
- Stringent controls over GMP raw materials & released by QC to GMP manufacturing
- Comprehensive Batch Production Records (BPRs) and Dedicated SOPs
- Qualified GMP equipment with validatable manufacturing process.
- Highly qualified staff, with expertise in newest chemical/peptide synthesis technologies.
- Segregated upstream process from downstream cleanroom ISO 7 certified area.
- Line clearance activities between every project to mitigate cross-contamination. Line clearance operations are verified and approved by QA before releasing room to GMP manufacturing.
- Lot to lot reproducibility, consistency, and traceability.
- Full QC testing and characterization of final product.
Critical Raw Materials (CRM)
We specialize in the manufacture of peptide and dye critical raw materials for use in Diagnostics, Ex-Vivo Cell Therapy, NeoAntigen Development, Cosmetics, or as critical raw material in clinical phase studies.
CRM Applications:
- Diagnostics :Analyte specific reagent (ASRs)
- Cosmetics : Signal or carrier peptides used as anti-wrinkling, anti-aging or moisturizing reagents in creams or lotions
- ex-vivo Cell Therapy : Activation of T-cells using peptides for clinical applications
- NeoAntigen : Tumor peptides used to activate the immune system
- BioManufacturing starting materials : API starting materials
