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.
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.
Tufts CSDD Study Assessing the Financial Benefits of Translational Pharmaceutics®: A Platform for Accelerating Product Development
This webinar summarizes the key findings of the recent Tufts CSDD research into Translational Pharmaceutics, the innovative approach to drug development. It demonstrates significant time savings of >12 months and financial gains of >$100 million per drug approved.
AAPS 2019 Poster- Comparison of Two In-Silico Modeling Programs, ADMET Predictor® and Percepta® to Predict Intrinsic Solubility and pKa of Poorly Soluble Drugs
Presented at AAPS 2019: Aqueous solubility is a prerequisite for oral absorption of a drug and the pH-dependence of aqueous solubility is critical information to guide formulation development strategies. The purpose of this study was to evaluate the physical property modules in two commercially available in-silico modelling programs in predicting the pH solubility profiles as described by the ionization constant (pKa) and the intrinsic solubility of the unionized form.
AAPS 2019 Poster- A Phase I Study Allowing Clinical Screening of Multiple Solubility-Enhancement Formulation Technologies, and an Assessment of Food, PPI and Dose Linearity Assessment with the Selected Formulation of BOS172767, in Healthy Volunteers
Presented at AAPS 2019: Translational Pharmaceutics was used to evaluate three BOS172767 formulations in on a integrated clinical study, and successfully identified the micronized capsule as the new lead formulation. This formulation had superior exposure compared to the IR reference capsules, and approximate proportional increase in exposure up to 800 mg. The food effect observed at 100 mg was reduced compared to that previously seen at 200 mg (FIH capsule) and elevated gastric pH (subjects taking PPIs) had minimal effect on exposure. A Level C IVIVC was achieved with a biorelevant dissolution test, which provides valuable information for future formulation development and setting of product specifications.