Quotient has manufactured and dosed its 50th intravenous drug product using a rapid aseptic manufacture approach that has been reviewed and approved by the UK MHRA. Developed as part of its innovative translational pharmaceutics platform, Quotient manufactures ‘fit for purpose’ intravenous drug products to GMP for ‘real-time’ dosing at its clinical facility in Nottingham, UK.
This approach enables Quotient’s customers worldwide, which include the world’s top pharmaceutical firms as well as small to medium-sized companies, to generate intravenous human pharmacokinetic and absolute bioavailability data more rapidly and cost effectively, to support exploratory drug development and regulatory approval.
In parallel, Quotient has also successfully delivered its 21st program using its Synthesis-to-Clinic (S2C) platform.
S2C is a unique platform that integrates all of the components required for 14C enabled drug development, including 14C API synthesis, preclinical and clinical testing, through to data analysis and reporting. To date, the major application of this “coming of age” platform has been in the delivery of human clinical mass balance and metabolism data to support regulatory submissions.
Mark Egerton, Managing Director of Quotient Clinical, commented: “With the growing number of microdose and microtracer applications, and the increased importance of human metabolism data, 14C enabled drug development is becoming increasingly important to our customers.
“We are committed to providing innovative services to ensure that these programs of work are delivered in a high quality, and time and cost effective manner”.
For more information on Quotient Clinical, 14C enabled drug development and Synthesis-to-Clinic, please call +44 (0)115 974 9000, email clinical@quotientbioresearch.com or visit www.quotientbioresearch.com/clinical.
For further information, please contact:
Chrissie Walker
bcsAgency
Tel: 0115 948 6900
Email: quotient@bcsAgency.com
About Quotient Clinical
Quotient Clinical is a business unit of Quotient Bioresearch. Quotient Clinical specialises in early clinical drug development and offers a unique streamlined process to reduce the time from First-in-Human studies through to Proof of Concept, integrating flexible drug product manufacture into clinical trials. With an existing strong customer base in the United States, Europe and Japan, the principal focus of Quotient Clinical is to provide a unique and comprehensive range of early development services to a broad range of pharmaceutical and biotechnology customers.
About Quotient Bioresearch.
Quotient Bioresearch is a leading provider of early stage and specialised drug development services to life science clients worldwide. The company offers a unique range of services through its three business units – Chemistry and Metabolism, Bioanalytical Sciences and Clinical. Quotient has grown rapidly in the past few years through a combination of both acquisition-led and organic growth.
For further information: www.quotientbiroesearch.com
