Process Development

Upstream

At Pegasus Biotech, we specialize in the development and scale-up of low-cost, high yielding upstream processes for our clients. Our expertise includes fermentation development from shake-flask up to 30L and cell culture up to 10L. Our experienced team of professionals is equipped with the latest technology to optimize media formulations and growth conditions, ensuring a smooth, efficient and cost effective process. We understand that every project is unique, and that’s why we take a personalized approach to every client’s needs. Our team has experience working with a wide range of microorganisms, including difficult to grow pathogens, for vaccine development purposes. We are committed to providing our clients with the highest quality service, and we take pride in our ability to deliver results that exceed expectations.

Premaster/Master Seed Development

At Pegasus Biotech, our value proposition is centered on getting our clients to market faster using processes that are compliant with global regulations. We understand the importance of a well-executed Pre-master/Master Seed Development program, and we have the expertise to create your master seed bank, including completing the necessary testing and paperwork required for submission to regulatory authorities. We utilize state-of-the-art technology and methodology to ensure that the seed bank we develop for you is of the highest quality. Our team has extensive experience in managing the regulatory requirements associated with seed bank development, and we will work closely with you to ensure that your program meets all necessary guidelines.

Purification

Pegasus Biotech understands the importance of reproducible, high yielding, and low-cost purification schemes that are fit-for-purpose. We work for our clients to develop lysis methods, tangential flow filtration methods, and/or column chromatography methods up to pilot scale that will yield a product that is suitable for the regulatory requirements while still having a superior cost of goods sold (COGS). Our team has a wealth of experience in developing methods for purifying API for vaccine products for both the human and animal health market. We use the latest technology and methodology to ensure that the purification scheme we develop for each client is robust and efficient, and we will work closely with you to ensure that it meets your specific needs.

Formulation

At Pegasus Biotech, we understand that every project has unique formulation needs, and we are committed to tailoring our approach to accommodate what each client requires. Our team of experts has a depth of experience in developing complex emulsion-based formulations for vaccine use, utilizing a variety of different technologies. We will work with you to identify the most appropriate formulation approach for your project, taking into account factors such as stability, efficacy, and patient safety. This formulation work is further supported through the use of the Pegasus’s broad suite of analytical assays, including high-performance liquid chromatography (HPLC), viscosity, and particle sizing. Our goal is to provide you with a robust, efficient, and cost-effective formulation that meets your specific product needs.

For more information on our process development services, call us at (855) 498-3398, or send us your information using our contact form.

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