GMP manufacturing requires considerable documentation and regulatory support. All
GMP peptide projects at Bio-Synthesis Laboratories include a complete service package
pricing which includes all the services needed to reach approval of your API.
Among our many resources and service we provides:
FDA-compliant cGMP facilities
Chemistry, Manufacturing and Controls (CMC) Documentation in Common Technical Document
(CTD) format for INDs
Drug Master File (DMF) Compilation
Our GMP Service Package includes:
GMP manufacturing requires considerable documentation and regulatory support. All
GMP peptide projects at Bio-Synthesis Laboratories include a complete service package
pricing. This covers all the services needed to reach approval of your API.
All GMP manufacturing procedures
Preparation and characterization of an in-house reference standard
In-house impurity reference samples
Analytical development and characterization
Analytical validation
Full stability testing according to ICH guidelines (over 4 years at storage temperature)
Process validation
All batch documentation and any support documentation required, including a CMC/IND
package
Support with regulatory agencies
Our Standard GMP Specifications include :
Mass Spectral Analysis
Amino Acid Analysis (AAA)
Sequencing
RP-HPLC
Residual Organic Volatiles
Bacterial Endotoxin Evaluation
Bioburden Evaluation
Net Peptide Content by AAA Counter Ion Content (Acetate, Trifluoroacetate, Hycrochloride
and more)
Secondary Counter Ion Content
Appearance
Solubility
water content
Mass Balance Calculation