Big Pharma’s interest in peptide drugs continues to grow and drug makers are turning to peptide contract manufacturers & discovery firms to help them launch the next generation of drugs.
The world of Peptide Active Pharmaceutical Ingredients (APIs) and Drug Intermediates manufacturing has become much smaller in the last 20 years as borders and barriers to international trade have fallen. Nonetheless, selecting the right contract research and manufacturing partner for your product needs should be carefully thought-out.
Here are three things to consider when selecting a peptide contract manufacturer for your drug candidate:
- Scale of Manufacture & Versatility of the Contract Manufacturer
Many contract manufacturers focus on specific production stages, offering limited capabilities at either the lab or bulk manufacturing ends of the scale. The earlier in the process you are, the easier it can be to address future regulatory and capacity issues. Increasingly, firms are looking for CRO/CMO providers that can – when needed – offer a pathway from research and pilot labs all the way through commercial manufacturing.Production of peptide APIs can be accomplished in two different ways, and each has distinct advantages. Solid Phase peptide manufacturing – which offers short development cycles – is often sufficient for pre-clinical development and proof of concept studies in which small amounts of an API will be needed (<1 – 2 kg). Solution Phase production, on the other hand, is the best approach for peptide APIs containing less than 10 amino acids. It’s also very scalable and delivers better control over the product and intermediates. Longer peptides (e.g., Fuzeon, which is 36 amino acids long) are synthesized using a hybrid approach.Depending on your timelines, you need to select a contract manufacturer who is versatile in both synthesis approaches, and selecting a manufacturer who can only meet your short term needs can be an expensive proposition. At Neuland Labs for example, our clients frequently have an urgent need that demands solid phase synthesis, as well as longer-term – and more commercial – objectives that we fulfill with solution phase synthesis.Your manufacturing partner gains valuable experience working with your drug candidate, but signing up one CMO for several life-stages of the product offers other key advantages, as well. Contract manufacturers have become very good at transferring in the various technologies and methods used to produce your product, but undertaking tech transfer at each stage of the process invariably costs you both time and money. Using a single manufacturer eliminates these issues.
- Effective Communications
The latest technology can make your worldwide operations much easier to manage, and some CROs, CMOs and API suppliers are riding the technology curve. Real-time monitoring solutions – such as the GuarD project management system here at Neuland Labs – allow clients to check the status of their product remotely from anywhere, at any time. With up-to-the-second production information at their fingertips, Neuland’s customers can keep their fingers directly on the pulse of critical operations.It’s critical to have effective oral and written communications with your CMO. Having a local contact representative available to you – coupled with clear, concise communications in your language – are a must.
- Regulatory Support
You must understand your drug candidate’s path to market in various nations worldwide, and select a manufacturer that is compatible with your marketing plans at each stage of your product’s lifecycle. For example – if you plan to enter the U.S. market, is your contract manufacturer FDA-inspected?You need to consider all of the following questions. Are all process and manufacturing operations performed in accordance with cGMP requirements, US FDA, and ICH guidelines and regulations? Have their facilities received a GMP certificate from the German Health Authority, or have they been successfully audited by Japan’s PMDA? What about DMFs – have they filed in a wide range of markets? One of the keys to selecting an appropriate contract manufacturer is to understand not only your target markets, but exactly which ones your manufacturing partner will be able to service.If you’ll need APIs at various scales of manufacturing for your peptide drug candidate, look for manufacturers that offer seamless regulatory support at each stage along the way. A contract manufacturing partner should support the customer with complete documentation, including Drug Master Files for their dosage form applications/ANDA filings.
As you consider a contract manufacturing partner for your peptide drug candidate, make sure their regulatory capabilities, scale-up & manufacturing versatility, IT infrastructure capabilities and communications are in-line with your Company’s needs – both today and in the future.