Quotient Sciences, a leading global pharmaceutical drug development and manufacturing accelerator, is proud to announce the successful completion of a US Food and Drug Administration (FDA) inspection of its bioanalytical facility in Alnwick, UK.

The regulatory inspection was conducted to audit three bioequivalence studies for three different insulin analogues for a renowned pharmaceutical company.

Quotient Sciences' Alnwick facility has specialty bioanalytical expertise and facilities for conducting bioequivalence studies, which play a crucial role in evaluating the similarity between pharmacokinetic properties of two proprietary preparations of a formulation. This is an essential step in the drug development process, enabling pharmaceutical companies to demonstrate that their generic versions of a drug are therapeutically equivalent to the corresponding branded product.

The US FDA inspection of Quotient Sciences' Alnwick facility is a significant achievement for the organization, highlighting its commitment to upholding the highest standards of quality and regulatory compliance. It reinforces Quotient Sciences' reputation as a trusted partner in the development of pharmaceutical drug products.

During the inspection, the US FDA thoroughly reviewed the facilities, systems, and processes at the Alnwick site. This comprehensive evaluation included assessing adherence to Good Laboratory Practice (GLP) and ensuring compliance with regulatory guidelines. The US FDA authorities inspected the facility for five days, from July 24 to 28, which concluded with a findings meeting that was also attended by the head of GLP for the MHRA Quotient Sciences' facility successfully passed the inspection with no observations or concerns noted, demonstrating its strong quality management systems and dedication to patient safety.

The Alnwick's site GMP facilities have previously been audited by the FDA and MHRA several times over the past 18 years, however this was the first US FDA audit that was specifically for bioanalytical work.    

MARK EGERTON, CEO of Quotient Sciences, "By successfully completing the US FDA inspection for these studies, Quotient Sciences has achieved another milestone in its mission to support the development of innovative medicines for patients worldwide.

"The results of the inspection further strengthen our track record for outstanding regulatory compliance at our Alnwick facility.

"At Quotient Sciences, we work diligently to maintain high quality standards and continuously improve quality platforms to ensure that we are meeting regulatory requirements that best support our global customers regulatory submissions"  

You may have noticed a change this week as we have debuted a fresh look for quotientsciences.com! 

Take 5 minutes to read a brief overview on some differences that you'll find as you navigate our new website.

We've given our site a modern look, with a faster and more mobile-friendly experience.

Speed and agility are pivotal to our brand promise, and we wanted to make sure to reflect this, not only in the services and programs we offer but in how we deliver information to you through our digital channels, starting with our website. 

In redesigning our website, we've paid close attention to where previous features impacted page speed. Additionally, a new content management system for our website offers us technical features that you can't outwardly see, but also enable us to deliver content that you're looking for, fast.

We've made design and technical improvements for greater attention to accessibility.

The concept of website accessibility means that websites and related tools or technologies are designed and developed so that people with disabilities can perceive, understand, navigate, and interact with them, contributing to a more diverse and inclusive web experience. In this redesign, we've made improvements to ensure that our website is more inclusive to use for all. Consistent size of and visibility of text, consistent use of descriptions on images, and adjustments to how our brand colors are applied were some of the steps made to give a more accessible experience. We recognize that technology and accessibility needs will continue to evolve, and aspire to implement future changes to keep up with those changes.

New content and easier access to understanding our capabilities added following insight gathered from our teams and customers. 

In our blog, you can search for a specific topic, subject matter expert, or Quotient Sciences location. Also, for those actively looking to join Quotient Sciences, or just wondering what life is like at our company for a future opportunity, you'll find careers- and location-related content in our blog and a redesigned experience on our careers page featuring new colleague stories. 

What hasn't changed: the continued emphasis on our mission of bringing molecules to cures, fast. 

We look forward to working with all of our customers, present and future, as partners in 2024. We value the important role that we have in supporting the development, testing, and manufacturing of new therapies that improve global health.

We hope you like the refreshed look and always welcome feedback. If you have any questions or comments for our team, please contact us at [email protected]. 
 

Dr. Sarah Stevens, former Vice President of Drug Development Sciences at Quotient Sciences, discusses our integrated approach to accelerating the development of poorly soluble compounds in a Drug Development & Delivery Special Feature article, "Improving Bioavailability & Solubility: Each Molecule Is Unique"

Solving bioavailability and solubil­ity challenges to support successful drug delivery is an ever-enduring challenge (and opportunity) for phar­maceutical formulation scientists. Along with well-established ap­proaches to improving each, there are many emerging platform technolo­gies, providing options in the toolbox. In many ways, though, availability of such formulation and process technol­ogy approaches does not present the primary barrier to improving universal solubility and bioavailability chal­lenges. Instead, a key challenge is the continued lack of predictive, clinically relevant models to guide formulation selection early enough in the develop­ment process – such that money and time are not unnecessarily expended, and avoidable risks not taken.

“With many examples of mislead­ing nonclinical and in vitro predictabil­ity out there, robust predictive models would afford the ability to understand and adapt for successful clinical out­comes from the outset,” says Dr. Sarah Stevens, Vice President of Drug Development Sciences at Quotient Sciences. “Quotient Sciences embod­ies science-led decision making, therefore not relying simply on poten­tially unreliable predictive models. A combination of unique development approaches provides the most expedi­tious means to improve potential bioavailability and solubility chal­lenges.”

Quotient, she says, deploys technologies such as particle size reduction, lipid-based formulation mechanisms, HME, SDD, etc., but more pertinently, drives early formula­tion selection by cutting through in­dustry silos and integrating across a range of capabilities to accelerate the drug development process.

Access the full article