HOUSTON, May 5, 2022 /PRNewswire/ — Avance Biosciences™, a leading CRO providing GLP/GMP-compliant assay development, assay validation, and sample testing services supporting biological drug development and manufacturing, announced today completion of move-in and validation of an additional 26,000 square feet of laboratory space acquired in the past year. Avance also announced expanded offerings of validated protein and cell-based assay services in support of their biopharma and CDMO clients for their therapeutic biologic’s discovery, development, and regulatory submissions.
As a long-time provider of genomics and biological testing services, Avance Biosciences™ offers a broad range of molecular biology and microbiology assays in compliance with current Good Manufacturing Practices (21 CFR Parts 210 & 211) and Good Laboratory Practices (21 CFR Part 58) to support its clients’ regulatory submissions.
These new facilities will be devoted to protein and cell-based assay services and enable Avance to better address the specific needs of their GMP clients. The expanded protein analysis services and assays offered by Avance Biosciences™ include:
- ELISA assays for protein biodistribution: direct, indirect, competitive & sandwich ELISA assays
- Residual Albumin by ELISA Residual Protein A by ELISA
- Residual Protein Assays
- Protein characterization and stability by automated Western blot analysis
- ELISA/Western blot for host cell protein analysis
- Custom tailored immunoassays
Additionally, Avance is expanding their mammalian cell culture related assay capabilities including: mycoplasma testing, adventitious agents testing, sterility, potency, and others.
As with existing capabilities, the Avance cell culture and protein labs provide comprehensive services including: assay design, development, qualification, validation, and sample testing.
Avance’s Director of BQC Laboratory Operations, Dr. Palas Chanda commented, “The addition of these mammalian cell culture and protein analysis services complements our well established NGS, ddPCR and qPCR genomics capabilities supporting gene and cell therapy development. These expanded service offerings ensure that we can meet our current and new customers’ varied biological drug development needs.”
Avance’s CEO, Dr. Xuening Huang commented, “This expansion and validation of facilities and services demonstrates our continued commitment to delivering world-class service and complete satisfaction to our customers. It further strengthens our position as a leader in the biologics development testing space.”
About Avance Biosciences™
Avance offers CGMP/GLP compliant genomics biological testing services in support of drug development and manufacturing. Its leading scientists have designed, validated, and tested thousands of assays under CGMP/GLP regulations for the FDA, EPA, and European and Japanese regulatory agencies. Avance’s team has extensive knowledge and experience working with scientists, QA/QC professionals and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.
9770 West Little York Road
Houston, TX 77040 USA