At StrataBio Consulting LLC, our scientific team has extensive experience in designing and executing analytical programs tailored to cell and gene therapies, mRNA-based therapies, and other advanced therapeutics. We specialize in a wide array of technologies and assays, including:

• Droplet Digital PCR (ddPCR) and Quantitative PCR (qPCR)
• Flow cytometry and cell culture
• Bioassays (MSD, ELISA, etc.) and biomarkers
• Potency assays

We ensure that all analytical methods are fit-for-purpose, compliant with regulatory standards, and optimized for each phase of development.

StrataBio Consulting LLC offers comprehensive expertise in pharmaceutical microbiology and environmental monitoring, ensuring product safety and facility compliance. Our capabilities include :

• Validation and implementation of non-compendial rapid microbiology testing, including rapid sterility and rapid mycoplasma detection.
• Bioburden and sterilization program management.
• Comprehensive environmental monitoring, such as routine EM, EMPQ, cleaning validations, disinfectant efficacy studies and gas testing, and aseptic media fill validations.

Our team helps streamline safety-related microbiology activities to ensure robust compliance from product development to commercialization.

StratBio Consulting's team has significant leadership experience in running GMP manufacturing operations, GxP laboratories for drug product testing, and CRO research labs. Our expertise encompasses:

• Streamlining operational processes to align regulatory and QA requirements.
• Method qualification and validation to meet regulatory guidelines at each phase of the product pipeline.
• Leadership in managing QA teams and ensuring compliance with GMP standards.

We focus on optimizing GMP operations to enhance efficiency, compliance and product safety.

StrataBio Consulting brings deep hands-on experience in applying cutting-edge technologies like NGS and metabolomics for advance therapeutic pipelines, especially in cell and gene therapy.

Our capabilities include:

• Whole Genome Sequencing and targeted sequencing.
• Long-read sequencing (Oxford Nanopore and PacBio).
• Single-cell sequencing and spatial transcriptomics (10X Genomics).
• Mutation and rare variant detection.
• RNA-sequencing.
• Human metabolic panels.

These technologies help our clients define critical quality attributes and optimize product characterization to meet stringent regulatory requirements.

Empowering therapeutics breakthroughs with proven expertise

At StrataBio Consulting, we bring a unique blend of scientific knowledge and practical experience to support the success of our clients in the rapidly evolving field of advanced therapeutics. Our team is dedicated to delivering tailored solutions that optimize operational efficiency, ensure compliance, and enhance the development of breakthrough therapies. Whether you need expertise in analytical development, GMP operations, or the latest advancements in NGS and microbiology, we are committed to partnering with you every step of the way. Together, we can transform challenges into opportunities and help your company achieve its strategic goals.