Biosimilars play an increasingly important role in the expanding global market for biotech medicines. To obtain regulatory approval, a biosimilar must demonstrate comparable safety and efficacy to the to the approved biological product. When bringing a biosimilar to market, a developer must meet the rigorous approval standards that apply to other pharmaceuticals, while recognizing the effects that a biosimilar’s molecular complexity may exert during development and manufacturing.
Navigating the challenges of developing a biosimilar through clinical trials while meeting regulatory guidelines requires an experienced partner. Q2 Solutions offers tailored solutions that will help you make informed decisions and shape validated outcomes for your study, from research to commercialization.
Q2 Solutions can partner with you to provide unique bioanalytic biosimilar capabilities, including:
Tailored, Science Based Solutions
A biosimilar must demonstrate clinical performance throughout the product’s lifecycle, and Q2 Solutions’ immunoassay services has experience developing, transferring and validating nonclinical and clinical assays to support biosimilar studies, including quantitative, immunogenicity and biomarkers assays. Specific bioanalytical capabilities include:
Pharmacokinetic (PK) concentration assays – Q2 Solutions has extensive experience developing or transferring quantitative immunoassays in a timely and efficient manner. Our veteran scientists have experience developing assays that span a range of molecule types, formats and instrument platforms. A single PK assay is recommended to be applied to demonstrate the bioanalytical similarity of the originator and biosimilar drugs.
Anti-drug antibody (ADA) or immunogenicity assays – A single assay also is recommended to be applied to demonstrate anti-drug antibody binding comparability in ADA assays. In addition, sensitivity and free drug tolerance are important characteristics to be optimized. Using techniques such as affinity capture elution (ACE), precipitation and acid dissociation (PandA), solid-phase extraction with acid dissociation (SPEAD) and paramagnetic microparticle-based approaches, Q2 Solutions can provide you with an optimized assay to mitigate interferences. In addition, Q2 Solutions will label and characterize your drug and will calculate ADA cutpoints in-house applying the latest industry-accepted guidelines.
Neutralizing antibody (NAb) assays – Q2 Solutions uses either plate-based competitive ligand binding (CLB) assays or cell-based approaches that are specific to your drug’s mode of action, immunogenicity risk assessment, technical feasibility and sponsor discussions with regulators to insure an appropriate format is applied to support your program.
Project Managers with Scientific Expertise
All Q2 Solutions Project Managers are scientists with hands-on experience in bioanalytical methodologies. We understand the science behind the assays and will serve as trusted partners in decision making. Through formal weekly updates, our Project Managers will keep you informed of progress and timelines while also offering practical advice through decision trees and assessing the impact of potential issues on the study. Q2 Solutions’ Project Managers strive to resolve issues through efficient, transparent collaboration, thereby assuring that assays run smoothly for the duration of the project.
An Efficient, Connected Workflow
From the earliest stages of development through validation and analysis, Q2 Solutions leverages our established network to ensure efficiency. For example, staff scientists at our Marietta, GA facility provide statistical analysis and protein conjugation services in-house, attention to critical reagent control and qualification thereby ensuring assay performance, accelerating data turnaround time and supporting high-throughput projects. Our Q2 Solutions bioanalytical laboratories integrate with central laboratory facilities, drawing on a depth of scientific expertise and providing flexibility as needed to navigate changes in the product development cycle.
A Proven History of Delivery Excellence
Our scientists are ready to partner with you to provide key insights into your biosimilar development program, regardless of the therapeutic area. Q2 Solutions’ bioanalytical laboratories have developed and tested thousands of samples for biosimilars and comparators that include:
• Adalimumab • Nivolumab • Pembrolizumab • Ipilimumab • Omalizumab • Rituximab
Our team of bioanalytical experts can collaborate with you at any step of the biosimilar testing process, from high-throughput assay development to navigating the evolving regulatory landscape. Quality is our priority throughout the bioanalytical development lifecycle – from method development to the delivery of the protocol final sample testing report, you can have confidence in the results. Contact us today to discuss how we can shorten timelines and increase the potential success of your product.