We can support a wide range of studies for both drug product and drug substance including packaging stability studies. We can also support studies involving radiolabelled compounds and controlled substances. We can accommodate short duration studies lasting a matter of weeks, to long term studies of months/ years. At some of our facilities, we offer not only ‘storage only’ studies, where sampling and dispatch is taken care of by our dedicated stability team, but ‘storage and test’ in which we can store, pull and test on site. Report generation and issue is managed through our Quality Management System, and reports are made available for client review and approval.

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast.

With fully integrated capabilities from First-in-Human testing to seamless drug product supply for patient trials, we simplify early development and accelerate molecules through to POC. Unparalleled in the pharmaceutical industry, our Integrated Programs get molecules to patients faster by dramatically shortening development timelines.

As a leading provider of human ADME studies and 14C isotope labelling for ADME studies, we have the scientific expertise and operational know-how to design and deliver human ADME programs in preparation for NDA, MAA and global regulatory filings. Learn more about our experts and our capabilities in our info sheet.

Peptide drug products continue to gain popularity in the pharmaceutical industry due to their high selectivity, high potency, and good safety profile. However, formulating peptides can present many challenges for drug developers because of their unique physicochemical properties.

CRDMO services that enable modified-release dosage forms to get to market. Fast.

Quotient Sciences capabilities for modified-release span the entire development pathway, from candidate development through to commercialization, reducing development risks and simplifying the supply chain for our customers. By taking a unique, integrated approach that is tailored to each program, we provide optimal results for our customers in the most efficient and cost-effective manner, getting new medicines to patients faster.

Integrated programs that bridge molecules from early discovery to proof of concept (POC) and beyond.

At Quotient Sciences, we have over 30 years of experience in the development of parenteral drug products, from candidate development through to clinical trial manufacturing via aseptic filtration techniques. Our innovative approach enables rapid development and manufacturing of sterile solution formulations for parenteral administration, with a strong emphasis on environmental and process controls. 

Dr. Stuart Mair, Global Vice President, Medical, Early Development, has contributed to a scientific article on Arthritis Research & Therapy.

Background
Mitogen-activated protein kinase (MAPK)-activated protein kinase-2 (MK2) is activated downstream of p38 MAPK and regulates the stability of mRNAs encoding inflammatory cytokines. CC-99677 is a novel, irreversible, covalent MK2 inhibitor under development for the treatment of ankylosing spondylitis (AS) and other inflammatory diseases. As part of a phase I clinical trial to assess safety and tolerability, we evaluated target engagement, pharmacokinetics, and pharmacodynamics of CC-99677.

Methods
The MK2 inhibitor CC-99677 was evaluated for its effect on cytokine expression in vitro in peripheral blood mononuclear cells (PBMCs) from healthy donors and patients with a definitive AS diagnosis. A novel in vitro model was developed to compare the potential for tachyphylaxis of CC-99677 and p38 inhibitors in THP-1 cells. The effect of CC-99677 on tristetraprolin (TTP) and cytokine mRNA was assessed in stimulated human monocyte-derived macrophages. In a first-in-human study, thirty-seven healthy volunteers were randomly assigned to daily oral doses of CC-99677 or placebo, and blood was collected at pre-specified time points before and after dosing. CC-99677 concentrations were assessed in the plasma, and CC-99677 binding to MK2 was evaluated in PBMCs. Ex vivo stimulation of the whole blood was conducted by participants in the first-in-human study to assess the pharmacodynamic effects.

Results
In vitro, CC-99677 inhibited tumor necrosis factor (TNF), interleukin (IL)-6, and IL-17 protein production in samples of monocytes and macrophages from AS patients and healthy volunteers via an mRNA-destabilization mechanism. In the in vitro model of tachyphylaxis, CC-99677 showed a differentiated pattern of sustained TNF protein inhibition compared with p38 inhibitors. CC-99677 reduced TTP phosphorylation and accelerated the decay of inflammatory cytokine mRNA in lipopolysaccharide-stimulated macrophages. Administration of CC-99677 to healthy volunteers was safe and well-tolerated, with linear pharmacokinetics and sustained reduction of ex vivo whole blood TNF, IL-6, and chemokine synthesis.

Conclusions
CC-99677 inhibition of MK2 is a promising approach for the treatment of inflammatory diseases and may overcome the limitations of p38 MAPK inhibition.

Gaur, R., Mensah, K.A., Stricker, J. et al. CC-99677, a novel, oral, selective covalent MK2 inhibitor, sustainably reduces pro-inflammatory cytokine production. Arthritis Res Ther 24, 199 (2022)/

Download Quotient Sciences' peer-reviewed resource, 'Controlled synthesis of SPION@SiO2 nanoparticles using design of experiments', published in Materials Advances.