Bring Vaccines to Market Faster

Validated and standardized kits enable QC departments to quickly achieve global quality initiative

World Vaccine Congress

April 22-24, 2025
Washington, D.C.

Visit Us at Booth #471

InDevR presents a Technology Talk
in partnership with CSL
April 21, 10:00 ET

Flu Wars: The Assay Strikes Back

Replacing SRID with an alternate potency assay

SeqirusHolly Springs, North CarolinaBrian Nunnally

Brian K Nunnally, Ph.D.
Vice President and Enterprise Head of Quality Control for CSL

The ….

Brian K. Nunnally, Ph.D. is the Vice President and Enterprise Head of Quality Control for CSL. Being the best quality control unit drives his passion. Prior to this role, he served as the Head of Quality Control for the Seqirus division of CSL after being promoted from the Site Head of Quality for the Holly Springs Seqirus plant. Before joining Seqirus, he worked at Biogen as the Director of Global Stability and also as a Global Regulatory CMC lead. Before joining Biogen, he was in charge of Process Validation for the Pfizer, Sanford, NC site. He is a co-author, with John McConnell, of the book Six Sigma in the Pharmaceutical Industry [2007, Taylor & Francis]. Dr. Nunnally has authored numerous publications in the field of analytical chemistry and operational excellence. He is a member of the CASSS Board of Directors and was a member the United States Pharmacopeia (USP) 2010-2015 Monograph 2 Expert Committee and two USP 2005-2010 Expert Committees (Reference Standards and Biotechnology and Biologics: Vaccine and Virology). Dr. Nunnally received two B.S. degrees (1994) from South Carolina Honors College, University of South Carolina, Columbia, and a Ph.D. degree (1998) in chemistry from Duke University, Durham, North Carolina. Prior to taking the Process Validation position, Dr. Nunnally worked in TO&PS Regulatory Affairs. He was responsible for leading the Sanford site’s contributions to one of the biggest filings in pharmaceutical history. Prior to joining TO&PS Regulatory, Dr. Nunnally was the Associate Director for GMP Operations in Vaccine Analytical Development at Wyeth. The group he led was responsible for all Reference Standards, Stability, GMP Testing, and Validation for the vaccine candidates Wyeth was developing. Dr. Nunnally has previously worked for Eli Lilly and Company. While at Lilly, he was responsible for leading a Quality Control laboratory devoted to new method development, method optimization, analytical testing for process validation, and analytical testing for manufacturing investigations.

Expert Services

InDevR’s Expert Services is a customized, efficient solution for vaccine manufacturers to help address and eliminate development bottlenecks and accelerate the analysis and validation.

Expertly Customized Assays – save months developing, optimizing, and validating in-house assays.
Multiplexed Assay Technology – enables quicker analysis over traditional single-plex methods like ELISA.
Integrated Custom Solutions – simplify your development and manufacturing bioprocesses.

Maximize Efficiency in Vaccine Development with VaxArray

Discover the VaxArray platform, your solution in multiplexed immunoassays designed to streamline vaccine development and analysis. This state-of-the-art system offers unparalleled precision and efficiency, empowering researchers to achieve faster, more reliable results in their efforts to advance public health.

High-Efficiency Testing – improve at-line analysis with multiplexed immunoassays.
Simplify Standardization – 21 CFR Part 11 compatible software and easy-to-use kits simplify standardization across workflows.
Versatile Platform – analyze a wide range of vaccine components, from antibodies and antigens to nucleic acids.

OmniFlu Multiplexed Assays for Subtype-Specific Influenza Analysis

InDevR’s VaxArray OmniFlu multiplex assay enables subtype-specific influenza vaccine quantification.

Achieve Results Faster – fast and easy with <30 minutes of hands-on time and <1 hour to result.
Highly Sensitive Assays – 100x more sensitive than SRID, with demonstrated equivalence for monovalent and multivalent vaccines.
Expertly Designed Reagents – capture reagents are selected to be robust against antigenic drift.

Custom VaxArray for mRNA

VaxArray assays can be customized to rapidly assess mRNA construct identity, quality, and cell-based expression from a single construct or multiplexed samples.

Custom Multiplexed Assays – multiplexed assay simplifies the development of high-valency mRNA vaccines.
Sequence-Specific Assays – sequence-specific capture oligos are designed for assessment of mRNA identity, quantity, and integrity.
Simplify Workflow Process – compatible with LNP formulations eliminating the need for laborious extraction procedures.