Quotient Sciences manufactures a range of simple to complex dosage forms, 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 and versatile manufacturing space, resources, 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 New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Marketing Authorization Application (MAA), and Japanese New Drug Application (JNDA) registration, the Quotient Sciences team can also support 505(b)(2) and CBE-30 filings.
Whether you are preparing for NDA, ANDA, MAA, or JNDA, Quotient Sciences has the expertise and regulatory approval to manufacture your validation and registration batches for the US, the UK, Europe, Brazil, and Japan.
Quotient Sciences can support all aspects of your drug product supply for Phase III clinical studies and commercial supply.
Quotient Sciences has vast experience across an array of dosage forms. Manufacturing for registration batches and commercial supply includes:
Quotient Sciences 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. Where projects transition across our sites, or intersect with other service providers, we will make the process seamless for you. For more information about Quotient Sciences 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 Sciences will help to mitigate risks and seamlessly advance projects into the later stages of development.
Technology transfers are not always straightforward, especially if the product and processes are 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 that may require certain equipment or processes, 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.
Quotient Sciences 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 (CPPs) and critical quality attributes (CQAs). Understanding these factors early in formulation and process development is key for successful scale-up.
Quotient Sciences 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.
HPAPIs are becoming increasingly common in drug development pipelines, especially in the oncology sector, as researchers search for therapies with greater selectivity and pharmacological activity.
HPAPIs present additional chemistry, manufacturing, and controls (CMC) challenges due to the containment requirements to protect both the operators and manufacturing facilities. Their production processes may also require greater precision and control due to the very small quantities of drug present in the final dosage form.
We are experienced at handling HPAPIs, from pre-clinical through to Phase III and commercial manufacturing. Learn more about our expertise in this area in our high-potency handling info sheet.
“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 Sciences, 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 Sciences 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, former Director, CMC at Amplyx Pharmaceuticals, now part of Pfizer