As we have entered the age of personalized or precision medicines, biotech and pharma companies are facing significant challenges both from manufacturing and supply chain standpoints. They have been impelled to shift from traditional large batch production to smaller and at times on-demand manufacturing runs to meet very specific patient needs—eliminating the one-size-fits-all approach. This is heightened in scenarios involving oncology patients, or those with rare & orphan diseases, which dictate that biotech and pharma companies must take a more patient-centric approach and supply drug products that are based on patients age, weight, condition and treatment requirements.
Driven by the unswerving belief that ideas need to become solutions, Quotient Sciences—a global pharmaceutical development, clinical, and commercial manufacturing organization—addresses all these requirements. The company provides tailored services and integrated programs across the entire development pathway from candidate selection to commercial supply. “Combining science and agility, we cut through industry silos to accelerate development for our customers, saving precious time and money in getting drugs to patients,” says Matthew Paterson, Vice President of Strategic Marketing, Quotient Sciences.
Having decades of experience in the industry, Quotient Sciences knows that every client is different—so are their requirements. That is why the company closely listens to their customers, to understand their challenges and to ensure that every program is geared toward a particular molecule with intensive planning and upfront efforts. For example, rather than promoting sophisticated or proprietary formulation technologies regardless of suitability, Quotient places the molecule front and center—firstly taking the time to thoroughly understand the molecule properties and behavior, and then deploying the most suitable formulation technologies to ensure clinical success. This could in some cases involve the simplest and least expensive formulation approaches.
Moving forward to product manufacturing, the company offers a variety of manufacturing paradigms which can broadly be categorized in three ways.
We provide flexible drug development and product manufacturing solutions tailored to the needs of each molecule and each customer
One is the widely used traditional large batch manufacturing for producing drug product in bulk. The second is brite stock manufacturing, where the product is manufactured in bulk but shipped out on a per-patient or per trial basis. The third option is real-time manufacturing, in which Quotient Sciences produces drug product in small batches, in real-time, specifically for a patient or a clinical trial. Within 7 to 14 days, Quotient Sciences will develop the product, package it, label it, and ship it to the clinical site or to the patient directly. Given the industry momentum surrounding precision medicines, such adaptive and more personalized manufacturing strategies are now in high demand.
Quotient Sciences differentiates itself in the marketplace by integrating a wide range of drug development and manufacturing services that would ordinarily be carried out at different organizations. For example, Drug Substance manufacturing—the synthesis of the active pharmaceutical ingredient (or API), Drug Product manufacturing—the development and supply of the finished dosage forms and Clinical Testing—the Phase I and clinical pharmacology trials to evaluate new drug candidates. Quotient Sciences thereby integrates all these CDMO and CRO activities under one umbrella and plays a vital role in helping clients achieve clinical milestones much more efficiently. “We have eliminated the silos between drug substance, drug product manufacturing and clinical testing,” says Paterson. In fact, Tufts Center for the Study of Drug Development(CSDD), a non-profit research center, wrote a paper entitled “The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical Testing." The paper authored by Joseph DiMasi, Director of Economic Analysis at Tufts CSDD and published in 2020 in the Therapeutic Innovation & Regulatory Science (TIRS) Journal, quantifies the financial benefits of the integrated development model from accelerated development timelines. The study concludes that Quotient Sciences’ Translational Pharmaceutics® approach to drug development reduces development times by more than 12 months, lowers R&D costs and creates multi-million-dollar financial benefits compared to traditional multi-vendor development paradigms.