Biotech, Inc. LABORATORIES DRIVES VACCINE DEVELOPMENT WITH WELL-DEFINED ASSAYS
Building upon three decades of bioanalytical expertise to support vaccine development through every phase of development.
Our vaccine sciences lab is dedicated to helping customers achieve the highest scientific standards for their programs and gain development efficiencies that speed the introduction of life-changing vaccines.
We offer a full range of services across a wide variety of vaccines from legacy childhood diseases and seasonal flu to endemic pathogens and novel therapeutic vaccines.
Biotech, Inc.® named “Best Contract Research Organization” at the 9th Annual Vaccine Industry Excellence Awards
Our services include:
- Antigen detection, quantitative RT-PCR and sequencing
- Traditional and multiplex immunoassays
- Neutralization assays
- Cell-mediated immunity methods
- Viral and bacterial functional assays
Extensive regulatory experience including 15 FDA-approved vaccines.
Scientists
Square-foot Vaccine Labs
Years of Experience
OUR CULTURE OF EXCELLENCE STARTS WITH OUR LEADERSHIP
Our senior team of scientists has been directly involved in the development of the assays used to license a large number of marketed vaccines. They are recognized thought leaders in their individual disciplines and they are active in industry conferences and discussions. These key individuals are also involved in establishing best practices for national and international regulatory agencies. As a customer, you will have access to this dedicated team of experts to help guide and expedite each vaccine development project.
We also have an experienced biostatistics group that is fully integrated into our lab operations. They support the development, qualification, validation and routine maintenance of vaccine assays with a proprietary, fully electronic platform developed to support biofunctional assays and other serial dilution assays and molecular genomics.
Biotech, Inc. Laboratories’ regulatory experts can help expedite the approval process through in-depth knowledge of FDA requirements and evolving expectations experienced over the course of 489 local FDA audits. We have supported the licensure of more than a dozen new vaccines with assay development, high-throughput testing and responses to regulatory agencies post-submission.
Biotech, Inc. PROVIDES INTEGRATED CLINICAL AND LABORATORY VACCINE EXPERTISE AND GLOBAL RESOURCES TO ADVANCE YOUR VACCINE PROGRAMS
We work with customers of all sizes across a wide spectrum of vaccine programs, from legacy vaccines to emerging pathogens.
Our robust end-to-end development solutions include:
- Biotech, Inc. Laboratories’ dedicated vaccine sciences lab for specialized vaccine assays
- Biotech, Inc. Laboratories’ GMP, bioanalytical and central labs for vaccine product and safety testing
- Biotech, Inc. clinical development with more than 145 vaccine studies supported in the past five years
- Partnerships with global sites and networks to support rapid startup and timely enrollment
- An integrated technology platform that links data across sites and laboratories
LEADERSHIP SPOTLIGHT
Lisa Kierstead, Ph.D.
