Assay Development and Technology Transfer to Expedite All Clinical Phases
From Fit-for-Purpose Development to Qualified and Validated Clinical Assays. Nexelis, a Q² Solutions Company, is a leading partner in assay development and technology transfer, with scientific discipline, critical thinking, and agility. Fit-for-purpose assay development on a wide variety of platforms support your small molecule, large molecule, or vaccine program through all phases of development. We have vast experience with assay transfer, developing 250+ successful assays and transferring them to sponsors around the globe. Our team has a wealth of biopharmaceutical and CRO industry experience developing and troubleshooting complex assays that meet regulatory requirements. With a track record supporting more than 350+ IND and regulatory filings, you can count on us for strategic pre-IND, IND, and late-stage collaboration with your regulatory agency.
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An offshoot of GSK Vaccines, with state-of-the-art platforms and unrivalled credentials, our Laval, Canada, and Marburg, Germany, facilities propel vaccine development forward. Strategically allied with the most prestigious vaccine manufacturers worldwide, we are well-known for our award-winning innovative viral assay development work.
Nexelis scientists are experienced with diverse scaffolds for immunotherapies. These include immunoglobulins, bispecific drugs, peptides, pegylated molecules, enzymes, antibody Fab fragments, nanobodies, and more. Our scientists designed a full range of assays to study the functional immune response of T-cells and macrophages or immunogenicity.
Custom Assay Development
Knowledge, diligence, and innovation comprise the scientific discipline found at the heart of every project we undertake. Our scientists apply their vast experience in a logical, efficient, streamlined approach. This approach determines the optimal parameters and conditions to produce a robust assay to fulfill our client’s requirements. From screening level through commercial scale assays, the agile critical thinking of our highly reputable scientists helps navigate challenges and evolve to support novel modalities. The result is high-quality data that enables critical decision-making.
Assay Qualification and Validation
At Nexelis, we have established, documented processes for qualifying and validating methods that are aligned with industry standards and regulatory guidelines and requirements. We execute these qualifications and validations following approved protocols and well-defined methodologies.
Our laboratory operation maintains a diligent documentation and data management through our LIMS and ELN systems following our standard operating procedure as defined by our Quality Management System (QMS). This includes records of qualification and validation throughout the assay life cycle, and our method validation process ensures rigorous control of assay performance that demonstrates how the developed method fulfills its intended purpose.
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