Contract Research

World Leading Contract Research

NIBRT's team of bioanalytical characterisation specialists provide detailed analysis of biologics in line with ICH Q6B and Q5E requirements.

Our highly regarded scientists are situated in the award winning NIBRT facility with access to a state-of-the-art laboratory equipped with top-of-the-line instrumentation.

Working adjacent to our accomplished team of Principal Investigators carrying out cutting edge, industry aligned research in all areas of biopharmaceutical manufacturing, we are well positioned to support our clients in solving problems at all stages of their product development and production.

Services

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Case Studies

Generation of biosimilar
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3 Development and qualification of
Case Study 4
Case Study 5

Generation of biosimilar characterisation data for use in regulatory submission

Bridging data between CE-LIF and UPLC-FLR N-glycan profiling methods

Development and qualification of an improved method to quantify NANA...

Characterisation of a biotherapeutic in early-stage drug development

A Quality by Design approach: Development and qualification of a method...

Testimonials

Dr Simon Westbrook

CEO Levicept

NIBRT Contract Research has enabled Levicept to access a wide range of analytical services delivered through the provision of top specification analytical instrumentation.

In addition to providing protein and glycan analytical services their ability to develop new methods to meet our specific needs enables us to quickly resolve our analytical queries in timely and cost effective manner.

Working with NIBRT Contract Research has enable us to gain a greater understanding of our clinical candidate.

Top-tier patent litigation boutique law firm, London

Legal Partner

NIBRT came highly recommended from a contact in New York and we were not disappointed: Patrick Jennings and his team did a fantastic job for us on a very short turnaround.

Within a couple of weeks they had optimised several testing processes for measuring the purity of an antibody for the purposes of litigation and provided helpful results that were strategically important to the case.

No amount of effort was too much and Patrick and Caitriona provided daily updates, slide decks and telephone calls to keep the team apprised as to progress, Patrick even going so far as taking delivery of an HPLC column at his home address on a Saturday so that a valuable day’s testing could be saved.

We would recommend them universally and thoroughly enjoyed the experience of working with them.

Ten out of ten for service, quality and professionalism.

North American Law firm specialising in intellectual property

Legal Partner

We came across NIBRT Contract Research through our work with a leading expert in the Biotherapeutic characterisation field.

From first contact, NIBRT Contract Research has been an outstanding facility to work with.

The team at NIBRT Contract Research has been instrumental in pushing the boundaries of our testing needs. They are not only flexible, responsive and a pleasure to work with, they also go several steps further to help us problem solve and develop new ways to test our products and learn more about our systems.

NIBRT Contract Research is a top class analytical facility and we will continue to work with them and recommend them to our colleagues going forward.

We would use no one else.

Biologics Development, Horizon Therapeutics

Associate Director

“The NIBRT team’s extensive support and quality work was integral
in the success of our regulatory submission to the U.S. FDA.”