API Manufacturing Process Development, Tech Transfer and Validation

Successful development and production of Active Pharmaceutical Ingredients (APIs) depends on the speed, efficiency, and quality of the entire development process. Protheragen-ING provides scientific expertise, advanced technologies, and complete solutions to help you quickly achieve clinical trial milestones and accelerate the commercialization of your products.

Our focus is on providing support services for your API development. From early process optimization and process scale-up to commercial production, we can provide you with key services throughout the lifecycle to commercialize your project.

By choosing to work with us, you will have direct access to experts with deep chemistry knowledge and years of successful experience in supporting early and late-stage clinical development programs and commercial scale-up. Our scientific staff has cutting-edge technology and knowledge in multi-step chemical synthesis for traditional, complex API production.

Complete API Manufacturing Process, Synthetic Route Design, Validation and Optimization

Protheragen-ING's API development program includes:

• We provide initial synthetic route screening. The screened synthetic routes are subjected to the necessary laboratory tests.
• We are able to perform final synthetic route validation with initial impurity analysis and cost assessment, reaction standards in grams, and subsequent scale-up to kilograms prior to technology transfer.
• In addition, we offer consulting services to evaluate and improve the optimization of our customers' existing production programs, both R&D and production scale-up. For example, we replace older technologies with the latest API synthesis technologies, which can lead to cost reductions.

Technology Transfer Services

Technology transfer provides us with the opportunity to use our integrated approach and commitment to efficiency to give you a strategic and cost advantage. Our growing portfolio of innovative API technologies provides a range of patentable R&D to production processes, and Protheragen-ING offers a comprehensive technology program that includes all necessary technical support after technology transfer.

The full portfolio of non-infringing/innovative technology programs available for licensing and large-scale development includes:

• Complete scalable manufacturing processes and procedures.
• Preliminary analysis of impurities.
• Complete analytical data and methods of analysis (MOA).
• Manufacturing cost assessments.
• Samples of key intermediates and final active intermediates.

Protheragen-ING offers a flexible business model designed to establish a long-term partnership with you to help with product development and commercialization. If technology transfer is imminent, we can also accomplish it quickly and efficiently, getting your project on track early and securing your product supply.

If you are interested in this service and need more information, contact us and we will arrange for professionals to provide you with more information and discuss your specific requirements.