HYBIO has the facilities, experience, research team and track record to support your ANDA project throughout your peptide drug development process. A complete ‘price covered’ service package is included at HYBIO for all GMP peptide projects. We’ll set up a specialized team includes synthesis chemist, QA, QC and manufacturing staff etc. to focus on your project only, this will ensure us to scale-up your products with tight specifications even if in tight timelines.

Our GMP Service Package Includes:

• 1、All GMP manufacturing procedures
• 2、Preparation and characterization of an in-house reference standard
• 3、In-house impurity reference samples
• 4、Isolation and Identification for known and unknown impurities
• 5、Analytical development and characterization
• 6、Analytical validation
• 7、Full stability testing according to ICH guidelines
• 8、Process validation
• 9、All batch documentation and any support documentation required, including a CMC/IND package and a US or European DMF as needed

When you order custom peptides from Hybio, the peptides delivered will meet or exceed your requirements. In order to show you our commitment to quality, we guarantee that all custom peptides meet your requirements, or we will remanufacture your peptides at no cost to you.

Our Standard GMP Specifications Include:

• 1、Appearance
• 2、Solubility
• 3、Identity (via mass spectral analysis, amino acid analysis and HPLC)
• 4、Peptide purity (HPLC)
• 5、Related substances (HPLC)
• 6、Assay (peptide content)
• 7、Bacterial endotoxins
• 8、Counterion content
• 9、Water
• 10、Mass balance
• 11、Specific rotation
• 12、Residual organic solvents

We are the leader in manufacturing quality peptides and related products. We are your strategic partner throughout your peptide drug development process.

Tell us your Need and your Requirements
We'll synthesize a Free sample for you!
Please Contact:Janeli@hybio.com.cn