Clinical Trial Manufacturing Services

Clinical trial manufacturing

Understanding that early phase clinical testing is a pivotal milestone in the development of your drug product, Quotient offers a clinical trial manufacturing, testing and certification service designed to meet your individual requirements. Our innovative method of building integrated GMP and GCP programs provides you with a streamlined, flexible approach to drug product supply that reflects your clinical study design and timeline. We understand the time and cost pressures you face during early phase evaluation and work with you to ensure a rapid, seamless path from development to clinical trial supply.

We understand your need to move rapidly through clinical development and have built the capability to efficiently scale up drug product manufacturing processes to meet the demands of global clinical and patient supply requirements.

Dosage forms

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

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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)
Topical
Rectal
Parenteral

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.

A female scientist looking at the camera holding a flask with water

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

A female scientist in a clean room suit dropping liquid from a dropper into a flask

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.

Project management

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.

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