Clinical Trial Manufacturing
Clinical Trial Manufacturing (CTM)
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. Our innovative method of building integrated Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) programs provides 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 trial design and development to have built the capability to efficiently scale up drug product manufacturing processes to meet the demands of global clinical and patient supply requirements.
What can Quotient Sciences' clinical manufacturing services do for me?
- Use a variety of manufacturing approaches to make only the product you need, flexible on demand
- Tailor manufacturing, packaging, and clinical trial supplies to reflect your clinical trial design
- Improve cost efficiency by reducing drug substance and drug product waste
- Leverage our expertise in high-potency manufacturing
Dosage forms
We offer clinical 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 hot melt extrusion [HME]) dispersions, micronized and lipidic formulations
- Gels, creams, and ointments
Routes of delivery
Quotient Sciences has extensive experience of 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 active pharmaceutical ingredient (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/m3) dependent upon the type of compound, dosage form, and batch size.
Phase I, II, and III clinical manufacturing
Quotient Sciences supports all aspects of your drug product supply for Phase I, II, and III clinical studies:
- Manufacture of all major drug product dosage forms in our US Food and Drug Administration (FDA)- and UK Medicines and Healthcare products Regulatory Agency (MHRA)-approved facilities
- Packaging, including bottles, blisters, tubs, or tubes
- Multi-language label design (including translation)
- Post-study drug return and reconciliation
- 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 the clinical site
Aseptic manufacturing of parenteral drug products
Parenteral drug products, which include intravenous (IV), subcutaneous (SC), or intramuscular (IM) routes of administration, require careful planning, thoroughly trained personnel, and dedicated facilities to ensure patient safety. At Quotient Sciences, we have over 30 years of experience in the development of parenteral drug products, from candidate development to clinical manufacturing via aseptic filtration techniques. To find out more about our aseptic manufacturing capabilities, take a look at our latest info sheet.
At our state-of-the-art facilities, we have the expertise to develop, pharmacy compound, manufacture, test, release, and supply a range of formulations (IV, SC, and IM administration) for a variety of clinical study types, including first-in-human (FIH) healthy volunteer studies assessing safety, tolerability, and pharmacokinetics (PK), as well as radiolabeled formulations for human absorption, distribution, metabolism, and excretion (ADME) studies. These services can be utilized as a standalone offering or as part of a fully integrated aseptic drug development program for our customers.
Real-time adaptive manufacturing
Quotient Sciences' history and expertise in integrating manufacturing with clinical dosing enables us to manufacture, package, and release products in a matter of days or weeks rather than months. Combined with bright-stock and just-in-time (JIT) approaches, we maximize flexibility around batch size and timing supply to your selected site in response to emerging clinical data or patient recruitment — without affecting the availability of your drug product.
Global clinical trial supplies
We understand the challenges of managing clinical trials at numerous sites across multiple countries. Quotient Sciences can ease the headache of global product supply logistics and accelerate your proof-of-concept timeline. We’ll develop and manufacture your drug product, then seamlessly integrate a flexible packaging, labeling, and distribution strategy that's tailored to your clinical trial.
Managing the packaging, multi-language labeling, and door-to-door logistics, 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.
What Our Clients Say
"Due to the low density and poor flow characteristics of our drug substance, we experienced significant blend and content uniformity issues. By transferring our program to Quotient Sciences, the development team was able to quickly produce demo batches through multiple blending steps and roller compaction using the Gerteis Mini-Pactor. The increase in drug load from 25% to 40% was a significant improvement as we prepared for future Phase II/III trials and this ultimately benefits the patients by reducing the pill burden. We have successfully manufactured several GMP batches of tablets at various doses using a common blend. Quotient Sciences is an outstanding drug development partner with a no-nonsense approach, excellent communication, speed, and robust, easy-to-review documentation, from analytical methods to master batch records."
Sean Premeau, Director, CMC at Amplyx Pharmaceuticals
Resources
Learn more about clinical trial manufacturing
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Info SheetGlobal Clinical Trial SuppliesQuotient can ease the headache of global product supply logistics and accelerate your proof-of-concept timeline. We’ll develop and manufacture your drug product, and then seamlessly integrate into a flexible packaging, labelling & distribution strategy, tailored to your clinical trial.
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Scientific PostersEnhanced formulation decision-making in early phase clinical trials for parenteral productsThis presentation describes the principles and applications of Translational Pharmaceutics: an R&D platform integrating formulation development, real-time adaptive GMP manufacturing and clinical testing in order to accelerate drug development cycles.
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Info SheetClinical Trial ManufacturingUnderstanding 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.
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Scientific PostersReal time adaptive manufacturing - a new paradigm for personalized drug products in clinical development - AAPS 2015This poster reports on a new real-time adaptive GMP manufacturing paradigm serving patient and study needs by delivering personalized drug products on demand.