cGMP Peptide API Manufacturing

cGMP Peptide API Manufacturing | Peptide API CDMO | FDA/EMA Compliance | Science-Peptide

Need cGMP-compliant peptide API? Science-Peptide provides cGMP Peptide API Manufacturing services from toxicology approval to commercialization, following ICH guidelines, supporting FDA/EMA filing, robust process, and has helped many customers to be approved. Welcome to contact us.

People who do peptide drugs know that cGMP Peptide API Manufacturing is the most important link in the whole chain. When the declaration is submitted, the evaluation experts will not only look at the result, but also the controllability of the manufacturing process and the completeness of the data. After more than 20 years of experience in this industry, we know very well what a solid cGMP Peptide API Manufacturing system means behind the IND approvals. science-Peptide has an independent cGMP manufacturing base, from toxicology batch, clinical batch to commercialization batch, we provide the whole process of cGMP Peptide API Manufacturing service. We provide full cGMP API manufacturing services for Peptide APIs, following ICH guidelines and with complete documentation. In the past few years, we have assisted a number of clients to successfully pass the on-site audits and desk reviews by the Chinese, American and European drug regulatory authorities.

cGMP Peptide API Manufacturing, simply put, is to turn a peptide from a laboratory process into a stable, safe and traceable API under the framework of the current Good Manufacturing Practice (cGMP). It is not as simple as just buying a few pieces of equipment and renovating a clean room. It requires us to have a plan for every detail: where the materials come from, how to verify the equipment, how to control the parameters, how to deal with any deviation, and every step must be recorded.

Science-Peptide's cGMP Peptide API Manufacturing service is centered around these details:

Preclinical toxicology batch: this batch is fast and steady, to meet the needs of GLP toxicology study, and at the same time for the subsequent amplification to lay a good foundation.

IND filing approval: This is a "premiere" for regulators, and process development and validation data must be solid.

Clinical phase I-III samples: demand from a few kilograms to dozens of kilograms, between batches of impurity profiles, crystal type, content must be like from a mold.

Commercialized production: this time the fight is the stability of the supply chain and cost control, to ensure that non-stop supply, continuous supply.

Process Validation and Stability Studies: Data to prove that your process is consistently producing qualified products.

1. Hardware, we are serious about investing in
Our cGMP Peptide API Manufacturing site is located on 10 acres of land and was designed to meet the standards of the FDA, EMA, and NMPA. To be honest, every time we give a tour to a customer or an auditor, we feel confident that we have:

• Solid-phase synthesis workshop: automated reactors from 50L to 3000L are available, amplification is not a worry.
• Liquid Phase Synthesis Workshop:Specialized in long peptides that are not well done in the solid phase and require fragment condensation.
• Purification plant: Preparative HPLC, small flow rate to find out the conditions, large flow rate direct production, no need to change equipment.
• Freeze-drying and clean area: freeze-drying area of more than 30 square meters, clean area of ISO 7/8 level, should have all.
• QC Lab: HPLC, UPLC, LC-MS, GC, Our own quality inspector is more serious than you, after all, the data out, we have to sign the responsibility first.

All the equipment has gone through DQ/IQ/OQ/PQ, which is not a formality, it is to ensure that the cGMP Peptide API Manufacturing process, will not suddenly fall off the chain.

2. Process amplification, we have stepped in more pits than you
From grams to hundred kilograms, we have stepped on the pit in the middle: solubility changed, more by-products, purification yield dropped So now we do cGMP Peptide API Manufacturing, especially emphasize the concept of QbD. In the process development stage, we will find out which are the critical parameters (CPP) and which are the quality attributes (CQA). We run several times in the pilot plant to confirm that the yield, purity, and impurity profile after amplification match with that of the pilot plant before we dare to put materials into the large tank. When technology transfer, R&D and production people sit together, one by one, to ensure that the "dead hand" parameter is passed on to not go out of shape.

3. Quality control, we are on your side
Every batch of cGMP Peptide API Manufacturing has a "growth diary" from the day it is fed. You may be more familiar with the contents of the release test than I am: content, purity, related substances, residual solvents, elemental impurities, endotoxins, microorganisms methods are all validated (in accordance with ICH Q2), the data are real and traceable. Stability studies are in accordance with ICH Q1, long-term, accelerated, and influencing factors. All these data will be the hard currency in your declaration in the future.

4. Documentation and registration support, we help you get the word out
Many of our colleagues with R&D backgrounds have a headache when it comes to writing submissions. Our experience is to make the manufacturing process clear in a language that regulators can understand. We can provide:

• Process Development Report: Tell us clearly how we optimize step by step.
• Process validation program and report: Demonstrate that the process is stable.
• Analytical Method Validation Report: Demonstrate that the data are accurate.
• Heterogeneous Spectrometry Analysis Report: Helping you answer the must-have questions of your reviewer.
• Structural corroboration: NMR, MS, IR, full set.
• Deviation and change records: In case there is a hiccup, how we dealt with it is clearly written.

Our documentation system can withstand scrutiny, and we have also cooperated with our customers to undergo on-site audits by the FDA and EMA.

5. Supply chain, we think a little further ahead than you might
What is the biggest fear of cGMP Peptide API Manufacturing? Loss of supply of materials. Therefore, we have set up a dual-source procurement, amino acids, resins, solvents, and at least two qualified suppliers for each key material. For those with long purchasing period, we set up safety stock. We also have many production lines, so when one project is full, another one will take over immediately. In the past few years, during the special period, we have never let a customer out of stock, relying on this advance.

• For those who are ready to declare IND, you haven't got the toxicology approval and clinical samples yet? We will start from here, help you to lock the process, run all the data, and complete the filing information.
• If you need to expand your production capacity in clinical phase II: your previous process is not suitable for kilogram scale? We have a pilot plant specializing in this, to help you understand the amplification effect, so that the production of phase III samples is no longer fearful.
• Generic drugs to grab the first generic: what is the impurity profile of the original drug? We help you reverse analysis, optimize the process, to achieve the same impurity profile or even better, the declaration of information through a one-time.
• Looking for a stable second supplier for commercialized varieties: Worried about exclusive suppliers? Our production line and quality management system can take your orders and withstand audits.

A Shanghai-based innovative drug company had a peptide for dual reporting in the US and China. They were on a tight schedule at that time, so our project manager directly stayed at their place for a few days to finalize the process details. From toxicology approval to Phase I clinical samples, cGMP Peptide API Manufacturing gave the green light all the way, and they finally got both US and Chinese INDs. Later, at the celebration dinner, their R&D director said that he was most anxious when he saw the process validation report we gave him, and then he felt more confident.

Whether you are preparing for a toxicology study or looking for a reliable partner for commercialization, Science-Peptide's cGMP Peptide API Manufacturing, to put it plainly, is to help you take your peptide from "can do" to "can produce, can file, can market". We can help you turn your peptide from "being able to make" to "being able to produce, to file, and to market".