Clinical Trial Manufacturing

Tailored to meet the needs of clinical trial design and clinical manufacturing, focused on producing drugs for use in clinical research.
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Real-time clinical manufacturing and supply.

At a Glance

 

We use a variety of clinical manufacturing approaches to make only the product you need, flexible on demand. This is real-time adaptive manufacturing.

Tailor clinical manufacturing, packaging, and clinical trial supplies to reflect your clinical trial design.

Improve your clinical trial cost efficiency by reducing drug substance and drug product waste.

Leverage our expertise in high-potency handling and manufacturing to make your product on-demand.

Move rapidly through clinical trial design and development to have the capability to efficiently scale up drug product manufacturing processes.

Leverage our expertise to move rapidly through clinical trial design

Dosage Forms

We offer clinical manufacturing and testing services for all major dosage forms, including:
 

  • Solutions and suspensions
  • Drug or blend in bottle
  • Drug or blend 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

Delivery Routes

We have 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

Clinical Trial Manufacturing: What our customers say

"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 , Stealth BioTherapeutics

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
Former Chief Scientific Officer , Pulmatrix

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.

Sean Premeau
Former Director, CMC , Amplyx Pharmaceuticals, a subsidiary of Pfizer Inc.

Clinical Trial Manufacturing Services

Find out more about our GMP clinical trial manufacturing services that will meet your supply needs for investigational medicinal product (IMP) or investigational new drugs (IND) for global clinical trials.

Aseptic Manufacturing

Our innovative approach enables rapid development and manufacturing of sterile solution formulations for parenteral administration.

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Global Clinical Trial Supplies

We can facilitate global clinical trial supply logistics and accelerate your proof-of-concept timeline. Our clinical trial supply team works with you ...

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High Potency APIs (HPAPIs) Handling

Our global facilities are configured with the necessary controls for handling and processing highly potent API.

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