Manufacturing Considerations for Sourcing GMP Based Fermentation Services

The manufacturing industry is currently witnessing major revolutions. For instance, technology is making manufacturing easy and more productive. However, without good manufacturing practices, you risk plunging your company into problems. That’s why you need the right fermentation partners to help you take your manufacturing game to the next level. With experts, you are sure of quality services. Plus, choosing the best company gives you the confidence you need to concentrate on other important matters. So, how do you source GMP based manufacturing services? What are the major considerations should you keep in mind? Well, if these are the questions that you need answering, keep reading. This article is going to highlight the major considerations you shouldn’t forget when sourcing GMP fermentation services.

The Basics

It’s important to note that GMP fermentation is an extremely complex process. It demands a huge investment when it comes to expertise, equipment, and quality control. Also, you must invest heavily in the process to realize the best results. This makes it difficult for all companies to invest in developing all the required resources in-house. That’s why you need a deep understanding as far as the quality of systems, process development, and isolation are concerned. Also, you must understand strain development procedures, purification, and scaling up of operations—it will help you make the right decision as far as large scale formation based fermentation is concerned.

Fermentation Process Experience

GMP fermentation experience can make or break your fermentation process. So, don’t overlook it. Learn the basics of choosing the best prospective supplier. Ascertain whether that supplier understands the basic fermentation process. From optimization, process development, to media development—the supplier you choose should be equipped with the right experience in the fermentation process. He/she should also understand areas like scale-up and strain development to realize maximum productivity.

Quality Systems

Quality control systems are some of the most important bulwarks for protecting the safeguarding of the supply chain and ensuring patient health as well as safety. And this is particularly true when it comes to biologically based production. Therefore, quality must be extremely high on your list of criteria for choosing a provider of fermentation services.

When shopping around for a contract manufacturer, don’t expect that different companies will have identical standards. Nonetheless, they should have a comparable and compatible set of standards that ensure the production of high-quality products through fully compliant operations.

Remember, no manufacturer can risk using contract suppliers who don’t have the quality plus compliance systems in place. The service provider should clearly demonstrate reliability in its fermentation offering. If they don’t meet any of these, you shouldn’t consider engaging with them.

Technology Transfer As Well As Scale-Up

When a company decides to outsource a large-scale fermentation process, it must be ready to develop the process at the laboratory. The contract manufacturer will then work with the company throughout the technology transfer process. These relationships then go all the way to the scale-up and optimization processes.

That’s why it’s extremely important to identify a contract supplier who can offer extensive pilot-scale facilities as well as commercial-scale facilities.

The Bottom-Line

The above are major considerations you shouldn’t ignore when sourcing GMP fermentation services. These considerations are critical and can influence the formation output. Use them and take your fermentation process to the next level. Fermentation services from BTR are superior and dependable. So, make a nice move today!