Updating Manufacturing Processes to Improve Sustainability

CatSci Ltd, a process research and development company that offers lead optimization, route design and assessment, scale-up, and process optimization, won the 2018 CPhI Pharma Award for Excellence in Pharma: Contract Services and Outsourcing for the company’s novel bio-catalyzed manufacturing route for a generic API. According to Dr. Jonathan Moseley, CatSci’s technical director, this novel biocatalytic manufacturing process reduces costs and optimizes production. Pharmaceutical Technology spoke with Moseley about what makes the award-winning manufacturing process unique.

PharmTech: Can you tell us what makes your biocatalytic manufacturing process unique?

Moseley (CatSci): The biocatalytic technology used is standard, but the uniqueness lies in the application to flurbiprofen (FBP), an established non-steroidal anti-inflammatory drug in the same class as ibuprofen. A biocatalytic manufacture of flurbiprofen is novel, as recognized by the granting of a patent for this process (patent no. WO 2016110708, 2016).

PharmTech: What are the benefits to generic API producers?

Moseley (CatSci): The benefits of applying biocatalytic processes to older generic drugs such as flurbiprofen allows generic API producers to update old processes to newer, more efficient ones, usually increasing yield and quality, reducing plant occupancy and environmental burden, and creating an overall reduction in cost. It also gives generic API producers a potential intellectual property (IP) advantage over older established processes and competitors when a novel, patent protected process can be introduced.

PharmTech: How does this process improve the sustainability of generic APIs?

Moseley (CatSci): Biocatalytic processes are invariably more sustainable than classical chemical processes for a number of reasons. Biocatalytic processes often achieve more complex chemical transformations in a more efficient manner, which in itself contributes significantly to improved sustainability. Biocatalytic processes are also usually performed at or near room temperature, which reduces energy costs, and they are performed in water or water-miscible solvents, which avoid petrochemical-based solvents. This in turn results in a more benign waste stream, reducing environmental burden and resulting in easier, safer waste disposal, again with reduced energy costs.

PharmTech: How does this process optimize manufacturing?

Moseley (CatSci): This process provides for a more efficient way to prepare and separate the desired (S)-enantiomer/isomer of flurbiprofen from the isomeric (R)-enantiomer/isomer. The original classical process was inefficient and relied on multiple low-yielding crystallizations, and it eventually discarded the unwanted isomer as waste. This new process also has the potential to fully recycle the unwanted isomer by a short additional process, which greatly improves both the sustainability and the overall efficiency of the manufacturing process.