Drug Substance Services at Quotient Sciences

In need of drug substance development and manufacturing services?

With tactical deployment of best-in-class technologies, we minimize chemistry costs and move your drug substance supply off the critical path.

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We can reduce drug substance manufacturing costs by 50% from pre-clinical to Phase I

Passing from candidate selection through to commercial production, our streamlined approach to developing drug substances has been shown to reduce manufacturing costs by up top 50% from pre-clinical to Phase I.

Supporting your needs

Supporting your needs

We have the technologies and equipment to meet the demands for complex small-scale drug substance manufacturing.
Rapid scale-up

Rapid scale-up

We deliver high-purity drug substances and rapidly scale up manufacturing at our cutting-edge facilities.
40 years of experience

40 years of experience

We are experts in synthetic organic chemistry, flow chemistry, synthetic biology, and biocatalysis.

Leverage the expertise of Quotient Sciences, to benefit your business

Moving off the critical path

We help move your drug substance supply off the critical path. We can rapidly achieve your milestones with our tactical deployment of best-in-class technologies, that help minimize chemistry costs. Our focus is always on process velocity and economy, product purity, process scalability and safety.

Efficient scalability

Once off the critical path, drug substance can then be scaled to multi-kg quantities to support your supply. Or, as part of an integrated in-house drug substance-to-drug product package to support clinical trials or full-scale commercialization programs.

Extensive expertise

Our highly trained and experienced chemists support all aspects of drug substance development. Our services include:

Process Research & Development
Solid-State Services
GMP & Non-GMP Manufacturing
Stability Testing
Isotopic Labeling

Achieve your drug program’s goals with one, integrated partner

Translational Pharmaceutics®

Integrated development platform that is proven to reduce timelines by >12 months.
Clinical Manufacturing

Clinical trial supplies for oral, injectable and inhaled dosage forms.
Clinical Pharmacology

Phase I healthy volunteer studies & 14C Human ADME.
Commercial Manufacturing

Tech transfer, Process Scale-Up & Optimization, Lifecycle Management.
Drug Substance

PR&D, Custom Synthesis and drug substance characterization.
Formulation Development

Simple & complex dosage forms: PIB, PIC, Tablets, Poorly Soluble, Modified-Release, Pediatrics.
Bioanalysis

Rapid bioanalytical data in discovery, pre-clinical & clinical.
Data Sciences

Rapid access to clinical data & results to accelerate drug development.
Consulting

Holistic scientific advice at each stage of drug development.

Customer success

Customer Testiomonials at Quotient Sciences

“The combination of GMP manufacturing and clinical testing within one organization was, as far as we are aware, entirely unique... The understanding we have gained through working with Quotient Sciences in terms of both the formulation development and the manufacturing will be invaluable.”

Dr David Hava, Chief Scientific Officer at Pulmatrix

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“The company’s ability to integrate manufacturing and dosing really accelerated the conduct of the study and was one of the main reasons that Corcept Therapeutics selected Quotient Sciences to undertake the study.”

Hazel Hunt, Chief Scientific Officer at Corcept Therapeutics

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“Quotient Sciences’ real-time manufacturing capabilities were a key factor in determining the speed at which this study could be concluded, offering the rare combination or GMP manufacturing and clinical administration on the same site, even for complex formulations and dosage forms. This allowed us to progress much faster.”

Dr Phil Collis, Vice President of Development at BioCryst Pharmaceuticals

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“My first response was this is too good to be true, they can’t do that. We’ve been looking for this type of solution for years – it can’t be done. However, we made a site visit and, within three days, accepted the proposal... We had clinical data within weeks... reducing the overall timeline by half, if not more.”

Deborah Gouveia, Vice President, Program & Alliance Management at Stealth BioTherapeutics

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“Quotient Sciences is an honest and straight-forward company with a very progressive attitude... What makes them unique is the way in which the pharmaceutical products are made on site and transferred, without leaving the building, to the clinical unit and a good, large and reliable pool of healthy volunteers.”

Gillian C. Ivers-Read, Former Executive VP & Chief Regulatory Officer of Clovis Oncology

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Who are Quotient Sciences?

More than a CDMO:CRO.

Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast.

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