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Bioanalysis at Quotient Sciences - Q&A with Stuart McDougall

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Tailored to meet the needs of the clinical trial design

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.

What can Quotient’s clinical trial manufacturing do for me?

  • Use a variety of manufacturing approaches to make only the product you need, flexible on-demand
  • Tailored 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 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
  • Gels, creams and ointments

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, II and III 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 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 your clinical site
A female scientist in a clean room suit dropping liquid from a dropper into a flask

Real-time adaptive manufacturing

Quotient’s history and expertise in integrating manufacturing with clinical dosing enable us to manufacture, package and release products in a matter of days or weeks rather than months. Combined with bright-stock and JIT approaches, we maximize flexibility around batch size and timing supply to your selected site in response to emerging clinical data or patient recruitment — all without affecting the availability of your drug product.

A Quotient Sciences scientist in a clean room suit working in the laboratory

Global clinical supplies

We understand the challenges of managing clinical trials at numerous sites, in multiple countries. Quotient 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.

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.

Learn more about global clinical trial supplies

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, 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 is an outstanding 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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