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Clinical Trial Manufacturing , Clinical Trial Supplies

Getting product to the right patient at the right time: Flexible, on-demand product manufacturing and clinical trial supplies

Clinical Trial Manufacturing Phases at Quotient Sciences

In 2013, Quotient Sciences started working with a client that was developing a medicine for children with a rare genetic disorder linked to progressive debilitating liver disease. Children suffering from this illness often experience severe pruritus’ (severe Itching), leading to major disruption of sleep patterns and poor quality of life. In some of the most severe cases, children could be known to itch so much that they caused intense skin bleeding and it was not uncommon for parents/caregivers to have to change their bedding 2-3 times a night. As you can well imagine this caused a lot of stress for parents as well as a very high level of discomfort and anxiety for the child themselves.  

Quotient Sciences was tasked with manufacturing an oral solution on a “real-time” basis to support the Phase II patient trials to try to demonstrate proof-of-concept for the molecule.    

While working on this program, I received a phone call from a Study Coordinator at Birmingham Children’s Hospital, which was one of the clinical sites enrolling patients for the trial.  With tears of joy, she shared with me that the parents of a 12-month-old child being treated shared the news that the child`s sleep patterns had improved so much that they had now started to sleep throughout the night- without any signs of itching, discomfort, or bleeding. The family’s quality of life had simply “shot through the roof”. It was that conversation that reminded me why we do what we do at Quotient Sciences.

Quotient Sciences has developed a wide breadth of knowledge and expertise in the provision of drug product manufacturing and supply chain solutions globally for customers over 30+ years. Our focus has always been on helping our customers get the right product to the right patient at the right time, no matter what it takes. 

We are acutely aware of the sporadic nature of patient recruitment across multiple study sites in multiple territories and, as such, have developed a flexible adaptive approach to drug product supply provision.  Over the years, we have listened to and found solutions to our customer’s clinical supply needs and, as such, specialize in tailoring product configurations to meet both patient and flexible program needs. This can be summarized simply in Figure 1 below.

 Personalized "Real-time" ManufacturingBrite=Stock ManufacturingTraditional Batch Manufacturing
Batch SizeSmallLargeLarge
Dose FlexibilityHigh MediumLow
Labelling/ShippingPer patient/countryPer patient/countryBulk Product
Shelf-life stabilityShort-termLong-termLong-term
API ConsumptionLow LowHigh
Product Overage/WasteLowLow High
CostLowLow High

These tailored solutions are one of our differentiators in the marketplace and add tremendous value to customers and patients alike. As well as traditional large batch manufacturing, Quotient Sciences has developed alternative strategies to offer more flexible manufacturing solutions for customers.  This includes brite-stock manufacturing and personalized “real-time” manufacturing, packaging, and distribution to offer more patient-centric clinical trial supplies.  

Ensuring the product is only manufactured, packaged, and distributed when it is required, allows for:

  • Greater management and control of CMC cost investments
  • Avoids upfront stockpiling of drug products
  • Avoids waste of precious API and Drug Product
  • Offers dose flexibility to meet Patient and Program needs

To date, we have utilized this approach in the provision of over 2500 clinical drug product shipments, across 20+ countries in global territories and have directly provided drug product to 160+ clinical centers for onward patient provision.  It is through this breadth of knowledge, listening to, and acting on,  our clients changing needs, and “living the experience” that we feel we can really help the clients find their way through the maze that is global clinical supplies.

“But surely it’s as simple as getting product from A to B”… If only it was that simple! We have supported many clients over the years with this exact conundrum.

Many of our clients, from small biotechs through to large traditional “Big Pharma” have historically put a lot of emphasis on the development of a drug product concept and less so on the actual delivery of the subsequent manufactured product.

Anyone who has tried to ship Drug Product, or any other commodities for that matter, across differing borders, territories, and countries will know of the many “trip-wires” and challenges faced in ensuring the product arrives where it should, when it should, and without its integrity being compromised.

Quotient Sciences has the experience and capabilities to overcome such challenges and take the “headache away from the client” - managing everything from the actual distribution of products using specialist courier services, to handling local rules and regulations, to translating documentation, through to managing import and export licensing.

Furthermore, by truly understanding clinical trials, regulations, and the clinical trial design, we offer the following:

  • Expert consultancy  to define optimized clinical trials supply and logistics strategies, (where we will live and breathe the clinical protocol and study design alongside the customer);
  • Support and advice on the Randomization and Trial Supply Management [RTSM] system built with respect to drug product provision (how do I order my products to ensure they get to the clinical site on time?);
  • Reduced administrative burden with a single provider under a single contract (avoid those “headaches” created by a multi-vendor approach with additional layers of complexity);
  • Defining and designing robust packaging solutions to ensure product integrity through a thorough understanding of intended shipping routes, storage requirements, clinical design, and mode of administration for patients (it will either be a shipping lane we know well or if not we know who to ask);
  • Annex 13 compliant and 21 CFR Part 11 compliant label design services;
  • Label and Packaging Translation services;
  • Preparation of global distribution shipping documentation to help in the seamless dispatch of products to help avoid unnecessary delays at the port of entry;
  • Provision of shipping studies to “De-risk” subsequent Real-time drug product supply.

Our internal cross-functional operational teams from Pharmaceutical Sciences, Quality Assurance, Project Management, and Regulatory Affairs ensure all aspects of delivery are considered and factored into any devised strategy. 

This, along with our unswerving belief in ensuring ideas need to become solutions and that molecules need to become cures, fast, means that we focus and specialize in getting products to the right patient at the right time.


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