Accelerating Peptide Development: Strategies to optimize the formulation and manufacture of peptide therapeuticsRegister here
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.
In addition to manufacturing products for NDA, ANDA, MAA and JNDA registration, the Quotient team can also support 505(b)(2) and CBE-30 filings.
Whether you are preparing for NDA, MAA or Japanese NDA, Quotient has the expertise and regulatory approval to manufacture your validation and registration batches for the U.S., U.K., Europe, Brazil and Japan
Quotient can support all aspects of your drug product supply for Phase III clinical studies and commercial supply.
Quotient has vast experience across an array of dosage forms. Manufacturing for registration batches and commercial supply, includes:
Quotient Project Management has over 30 years of experience in supporting drug programs that are in late stage development and commercial. Our project managers will ensure your commercial readiness by providing end-to-end support from concept and project scoping, to project delivery. And where projects transition across our sites, or intersect with other service providers, we’ll make the process seamless for you. For more information about Quotient Project Management, click below.
Technology transfers and scale-up require a high degree of cross-functional integration. With detailed knowledge and expertise across all key areas – development, analytical, manufacturing, quality and regulatory – Quotient will help to mitigate risks and seamlessly advance projects into the later stages of development.
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 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.
High potency API Handling
“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