Facilities and Production Capacities
Our partner's cGMP manufacturing facility for chemical compound synthesis is located in New Jersey. This state-of-art cGMP facility is 143,000 square feet and has been inspected and approved by FDA. Its China GMP manufacturing facility is capable of producing hundreds of tons of APIs annually.
LifeTein has the capacity to perform solid-phase synthesis of 10 to 50 liters in volume. In addition, LifeTein offers Fmoc, t-Boc, Cbz, solution-phase synthesis, and fragment condensation as well as ligation chemistry. All purification and lyophilization processes are performed in specifically designed clean rooms. We can fill thousands of vials of lyophilized peptide in a sterile manner. Our synthetic chemistry experts will help you with your drug discovery and development processes. Please inquire about our GMP service or request a quote.
Quality Control
LifeTein has developed a quality assurance system covering all aspects required of the process of producing cGMP peptide APIs. All specifications are tested, including solubility, appearance, stability, peptide content, residual organic solvent content, counterion content, and endotoxins. We use gradient HPLC to purify the product to the client's specifications. The final compound is then analyzed again by reverse-phase HPLC to verify said purity. Mass spectrometry is used to verify the mass of the peptide.
We will work closely with you on your projects, offering full confidentiality. Our continued growth and success is the result of our commitment to customer satisfaction and to partnerships built on trust and quality.