Genomics

Avance Biosciences Announces Validation of New Facilities

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.”

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