How do I find a partner for clinical manufacturing?
Quotient is your answer.
We offer you manufacturing and testing services for all major dosage forms including:
- Solutions and suspensions
- Drug in bottle, drug in capsule
- Immediate, sustained and modified release tablets
- Solubilized formulations including amorphous (spray-dried and HME) dispersions, micronized and lipidic formulations
Routes of delivery
We have extensive experience developing and manufacturing drug products intended for all major routes of delivery:
- Oral (solid and liquid forms)
- Inhaled (pulmonary, nasal)
High-potency API handling
Take advantage of our state-of-the-art containment manufacturing for handling high-potency products which features isolator technology and engineered controls. Our containment classification is based on the Performance-Based-Level of Exposure Classification (PBLEC) allowing us to handle levels 1 through to 5 (or down to 0.1 µg/cubic meter) dependent upon the type of compound, dosage form and batch size.
Phase I and Phase II clinical trial manufacturing
Quotient can support all aspects of your drug product supply to support your Phase I, II and Phase III clinical studies:
- Manufacture of all major drug product dosage forms in our FDA and MHRA approved facilities
- Packaging including bottles, blisters, tubs or tubes
- Multi-language label design (including translation)
- Post-study drug return and reconcilliation
- Randomization and blinding
- Schedule I - IV controlled substance handling
- Shipment logistics and supply tracking
- Storage and distribution capabilities (ambient, refrigerated and frozen)
- Supply chain management to your clinical site
Real-time adaptive manufacturing
Our history and expertise of integrating manufacturing with clinical dosing enables us to manufacture, package and release products in a matter of days or weeks rather than months. Our approach maximizes flexibility around batch size and the timing of supply to your selected site, in response to emerging clinical data, or patient recruitment - all without affecting the availability of your drug product. Our approach can be used across all drug product types.
Our dedicated team of Project Managers is focused on delivering our customer’s clinical trial manufacturing projects on-time and on-budget. Quotient Project Management will provide end-to-end support from concept and project scoping, to project delivery, to making recommendations for late stage and commercialization. They will adapt along with your project to ensure your needs and the needs of your product are continuously met, that all risks are managed and mitigated and that all collaborators remain aligned with the objectives and end goal. And where projects transition across our sites, or intersect with other service providers, we’ll make the process is seamless for you. For more information about Quotient Project Management, click here.
Global supply management
Quotient Sciences has reached a clinical trial supply milestone, providing over 2,000 drug products to over 60 unique clinical sites in hospitals and contract research organizations worldwide. We have a strong track record of on-time delivery of clinical supplies supporting your Phase I and II clinical studies, managing the packaging, multi-language labeling and door-to-door logistics in accordance with your clinical design. Our clinical trial supply team works with you to design the most efficient process for drug product supply to your central hub or clinical sites including the provision of bulk drug product or individual patient kits.
Clinical Trial Manufacturing
Understanding that early phase clinical testing is a pivotal milestone in the development of your drug product, Quotient Sciences offers clinical trial manufacturing, testing and certification services designed to meet your individual requirements.
AAPS 2020 Poster - Scale-up challenge of a Low-Dose Tablet Formulation through blending and roller compaction optimization
The purpose of this investigation was to address the content uniformity challenge faced during the scale up for a low dose tablet formulation of Drug X on an accelerated development program. Experiments were performed to demonstrate optimized processing prior to clinical trial manufacturing (CTM).
Accelerating the Developing of Orphan Drugs for Rare Diseases
Worldwide there are over 300 million people living with identified rare diseases. This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging.
Project Management at Quotient Sciences
Quotient is an innovative drug development and manufacturing partner supporting clients from candidate selection to commercial launch. With expertise in end-to-end Project Management and integrated project teams, we make drug development easier for our customers and dramatically reduce the time and cost of getting new medicines to patients.