There are many benefits to using a pharmaceutical contract manufacturer (CMO). Many small to mid-sized pharmaceutical companies utilize them for developing their drugs when they don’t have their own facilities. For those companies that have already developed their pharmaceutical product or have licensed in a drug product, CMOs are a great place to transfer their existing product when they don’t have their own manufacturing site.
To transfer a product from an existing site to a new site involves what is known as a “technology transfer” (AKA “tech transfer”). In this blog post, we will list key things to consider ensuring an accurate quotation and a smooth tech transfer from one manufacturing facility to another.
Create a well-crafted Request for Proposal (RFP)
You can start by listing the scope of work you are looking for in the tech transfer. Your RFP should provide as much information about the drug product you are transferring to ensure an accurate process. At the minimum, it should include the name of the product (API), the master formula, equipment needed, the excipients, the SDS of the API, packaging specs (if required). You should also include your master batch records, desired batch sizes, annual forecasts, analytical transfer requirements, type of filing, cleaning methods, sources of excipients, and timeframe. The more details you provide in your RFP, the better vendor quotations you will receive.
Narrow down your top contract manufacturer list
Once you’ve received vendor quotations or proposals, it’s time to narrow down your list. Make sure they have the right equipment, people, systems, and communication style. Don’t forget to look at the quality systems! Once you have done that, it’s time to look at the pricing. It may be challenging to compare the prices between contract manufacturers due to the way that various CMOs quote. For example, there may be differences in what is included in the quote (excipients, testing, stability, etc.), batch size differences, shipping costs from the manufacturer’s location, timelines, and CAPEX costs to be considered. It’s best to pick a contract manufacturer willing to collaborate with you on how the transfer takes place and form a long-term partnership. Be willing to put in the time and effort as it will pay off in the long run.
Compile your tech transfer package
Ensure that you have the correct supporting documentation from your existing contract manufacturer. The documentation should include but is not limited to master batch records, analytical methods and reports, regulatory documentation, product stability reports, and drug specifications.
Project management is critical
Communication and mutual understanding play important roles in the success of your product’s technology transfer. A contract manufacturer must have a robust, well-trained project management team. You should ask about their qualifications and how they handle the tech transfer process. Having a dedicated Project Manager who will stick with you through the whole process will ensure a smooth transfer. They should be your key point of contact for anything related to your pharmaceutical product and advocate with their company. They should develop and provide you with your project timelines, review all costs, handle any change orders (if any) and lead the rest of the contract manufacturer’s team. Your Project Manager would also have key members of the various contract manufacturer’s departments (processing, analytical, packaging, quality, etc.) as part of their team for support.
Remember, every technology transfer is different but there are minimum standards and information to ensure a smooth transfer. Make sure to pick the right contract manufacturing partner that truly understands the tech transfer process and has robust systems that include the right equipment capabilities, high-quality standards, strong project management, and a robust communication style.
