NEWS Quotient Sciences Announces Multimillion-Pound Investment in Drug Substance Manufacturing Facility Read article Drug product and commercial manufacturing Pharmaceutical Commercial Manufacturing Quotient Sciences manufactures a range of dosage forms - from simple to complex - with a track-record of working with higher-value products that may require lower batch sizes in the market; such as those for oncology therapies, orphan drugs/rare diseases, and pediatric indications. As a trusted development and manufacturing partner, Quotient Sciences recognizes that speed, flexibility and agility are essential for establishing a successful commercial product supply chain. We offer commercial manufacturing solutions tailored to specific product and market needs. Rather than dictating minimum batch sizes, we partner with our customers to offer flexible, versatile manufacturing space, resource and scheduling to accommodate the needs of each individual project. Our highly skilled staff and experience from multiple successful launches, ensure that your project gets the focus it needs to accelerate through registration batches, process validation and onwards to a successful commercial launch. Scale Up Quotient supports customers at all stages of development and has a strong track record of scaling up from lab and pilot scale to commercial batch sizes. Deep technical expertise is underpinned by fully integrated departments and a strong project management capability. This enables seamless progression as a molecule transitions through development, with like for like manufacturing equipment trains from early to late stage manufacturing for scaling up from gram quantities to multi-kilogram batches. Maintaining product quality and robustness is essential. A team of dedicated formulation and process experts support the identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs). Understanding these factors early in formulation and process development is key for successful scale-up. Quotient also applies the principles of Quality by Design (QbD) and a Design of Experiments (DoE) approach to development. By systematically developing an understanding of the product and process, we help clients to build robustness and quality into the final formulation. Technology Transfer Technology transfers are not always straightforward, especially if the product and processes and being transferred between different organizations or onto different types of equipment. With fully integrated capabilities and common manufacturing processes across our sites, we ensure a quick and seamless approach to technology transfers. For transfers from an existing provider or even some products which may require certain equipment/ process etc., our multidisciplinary project teams will start by gaining a deep understanding of the history of the product. With this foundation we will work with the customer to develop and implement the product development plan. “Due to the low density and poor flow characteristics of our drug substance, we experienced significant blend and content uniformity issues. By transferring our program to Quotient, the development team was able to quickly produce demo batches through multiple blending steps and roller compaction using the Gerteis Mini-Pactor. The increase in drug load from 25% to 40% was a significant improvement as we prepared for future Phase II/III trials and this ultimately benefits the patients by reducing the pill burden. We have successfully manufactured several GMP batches of tablets at various doses using a common blend. Quotient is an outstanding development partner with a no-nonsense approach, excellent communication, speed and robust easy to review documentation from analytical methods to master batch records”. Sean Premeau, Director, CMC at Amplyx Pharmaceuticals Ready to get started? Share your project needs with us. About Quotient Sciences Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast. Follow us LinkedIn Twitter Facebook Contact us Quotient Sciences UK +44 (0)115 974 9000 US +1 800 769 3518 Get in touch Copyright © Quotient Sciences 2021 Policies, Statements and Terms of Use Suppliers We use cookies to help us to improve our site and enables us to the best possible service and customer experience. By clicking accept you are agreeing to let us share your data with select third parties for analytics and marketing purposes. Decline Accept