Quotient Sciences has a breadth of knowledge and expertise in the provision of drug product manufacturing and supply chain solutions. 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.
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. In these cases, it was not uncommon for parents or caregivers to have to change the child's bedding 2-3 times a night, causing a lot of stress for both the parent or caregiver and child.
Quotient Sciences was tasked with manufacturing an oral pediatric 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.
It was that conversation that reminded me why we do what we do at Quotient Sciences.
Adaptable clinical trial materials manufacturing
We are acutely aware of the sporadic nature of patient recruitment across multiple study sites in multiple territories and, as such, have developed an adaptive approach to drug product supply provision.
In addition to traditional batch drug product manufacturing, alternative strategies to offer more flexible solutions for customers include brite-stock manufacturing and personalized “real-time” drug product manufacturing, packaging, and distribution of 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 investments
- Avoids upfront stockpiling of drug products
- Avoids wasted API, especially when it is high value or available at limited quantity
- Offers dose flexibility to meet patient and program needs
To date, we have utilized this approach in the provision of over 2,500 clinical drug product shipments and have directly provided drug product to more than 160+ clinical centers in over 20 different countries for patient provision.
| Personalized "Real-time" Manufacturing | Brite=Stock Manufacturing | Traditional Batch Manufacturing | |
| Batch Size | Small | Large | Large |
| Dose Flexibility | High | Medium | Low |
| Labelling/Shipping | Per patient/country | Per patient/country | Bulk Product |
| Shelf-life stability | Short-term | Long-term | Long-term |
| API Consumption | Low | Low | High |
| Product Overage/Waste | Low | Low | High |
| Cost | Low | Low | High |
Over the years, we have listened to and found solutions to our customer’s clinical supply needs and specialize in tailoring product configurations to meet both patient and flexible program needs.
Getting drug product to the right patient at the right time
Many clients, from small biotechs to “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 raw materials, chemicals, and similar commodities, for that matter) across different borders, territories, and countries will know of the many tripping points 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 to overcome such challenges and take the headache away from the client. Along with manufacturing the clinical trial materials, we can then help coordinate the actual distribution of products using specialist courier services, handle local rules and regulations, translate documentation, manage import and export licensing, and more. Our cross-functional operational teams bring together scientific, quality, project management, and regulatory team members to ensure all aspects of delivery are considered and we can ensure that products get to the right patient at the right time.
Find out more: Global clinical trials supplies service from Quotient Sciences
With our deep understanding of clinical trials and drug product manufacturing combined, we offer a global clinical trials supplies service that extends to:
- Expert consultancy to define optimized clinical trials supply and logistics strategies
- Support and advice on the randomization and trial supply management (RTSM) system, built to ensure that drug products get to the clinical site on time
- Reduced administrative burden with a single provider under a single contract, avoiding challenges that come with using multiple vendors
- Consultancy and design of packaging solutions to ensure product integrity, factoring in intended shipping routes, storage requirements, clinical design, and mode of administration for patients
- Annex 13 compliant and 21 CFR Part 11 compliant label design services, including label and packaging translation services
- Preparation of global distribution shipping documentation, aiding in seamless dispatch of products and avoidance of unnecessary delays at the port of entry
- Provision of shipping studies to de-risk subsequent Rreal-time drug product supply
Find out more about our global clinical trials supplies service or contact us today to discuss your program.