Bioanalytical Testing

Bioanalytical Testing Services

At Xellera Therapeutics, we offer a comprehensive suite of Bioanalytical Testing Services to support the development and manufacturing of cell and gene therapies (CGTs). Our state-of-the-art quality control (QC) laboratories adhere to cGMP standards, ensuring precise and reproducible analytical testing that meets global regulatory requirements. We operate dedicated laboratory spaces and controlled cleanroom environments to uphold critical quality standards throughout the product lifecycle.

Our bioanalytical capabilities cover the full spectrum of analytical support, from early-phase characterization to lot release. We understand the specialized analytical methods and stringent quality control measures required for CGT manufacturing.

Our services include:

Comprehensive Bioanalytical Testing

Identity Testing

  • Flow Cytometry (FACS): Multiparametric analysis of cell populations, ensuring precise identification of cellular components.
  • Polymerase Chain Reaction (PCR): Highly sensitive detection of genetic material to confirm identity and integrity.
  • Immunoassays: Protein-specific assays for the identification of target molecules.

Viability & Cell Count

  • Assessment of viable cell populations using automated cell counting and Trypan Blue exclusion.

Microbial and Safety Testing

  • Sterility Testing: Performed according to USP <71> and EP 2.6.1 to ensure product safety.
  • Replication-Competent Virus (RCV) Testing: Screening for adventitious viral contamination.

Purity & Impurity Analysis

  • Detection of process-related impurities, including endotoxins, mycoplasma, and residual host cell proteins/DNA to ensure compliance with regulatory thresholds.

Potency Assays

  • Functional assays using cell-based techniques and ELISA to evaluate biological activity.

Stability Studies

  • Long-term and accelerated stability assessments per ICH guidelines to establish product shelf life.

Vector Characterisation

  • qPCR-based assays for viral vector characterization, genome copy number determination, and transgene expression analysis.

Specialized Bioanalytical Testing Services

Flow Cytometry (FACS)

Flow Cytometry, or Fluorescence-Activated Cell Sorting (FACS), is a powerful technique for analyzing cell populations based on size, complexity, and marker expression. Our advanced flow cytometry services support:

✔ Immune profiling
✔ Cell viability assessments
✔ Phenotypic characterization for research and clinical applications

ELISA Immunoassays

Enzyme-Linked Immunosorbent Assay (ELISA) is a highly sensitive and specific technique used to detect and quantify proteins, antibodies, hormones, and other biomolecules. Our ELISA services provide accurate and reproducible results, supporting applications in drug development, diagnostics, and quality control.

Endotoxin Testing

Bacterial endotoxins are among the most common pyrogens in pharmaceutical and medical products, posing significant health risks if undetected. Endotoxin contamination can cause:

✔ Hemorrhagic shock
✔ Meningitis
✔ Fever and immune response alterations
✔ Gastrointestinal distress
✔ Rapid drop in blood pressure

To ensure product safety, we perform bacterial endotoxin testing using the Limulus Amebocyte Lysate (LAL) assay, compliant with EP 2.6.14 guidelines. This test is the gold standard for detecting endotoxin contamination and is an essential lot release requirement for pharmaceutical and biopharmaceutical products.

Mycoplasma Testing

Mycoplasma contamination can severely impact cell culture integrity and biopharmaceutical production. Our PCR-based mycoplasma testing follows EP 2.6.7 guidelines, enabling the detection of various Mycoplasma species, including:

  • Mycoplasma pneumoniae
  • Mycoplasma arginine
  • Mycoplasma orale
  • Mycoplasma fermentans
  • Mycoplasma hyorhinis
  • Acholeplasma laidlawii

Best Practices for Mycoplasma Testing

Regular testing is critical to maintaining product integrity. We recommend testing:


✔ Upon receiving a new cell line – Contamination can originate from suppliers or collaborators.
✔ After every 10 passages – Routine checks prevent prolonged exposure and spread.
✔ Before freezing cell stocks – Ensuring contaminant-free cell banks preserves sample integrity.
✔ Whenever contamination is suspected – Unexplained experimental variability warrants immediate testing.

Commitment to Quality & Compliance

At Xellera Therapeutics, we collaborate with clients at every stage of the bioanalytical process, ensuring robust, reproducible analytical methods that align with regulatory standards.

Our QC team plays a pivotal role in expediting process development, regulatory approval, and commercialization of CGT products by implementing cutting-edge analytical techniques that facilitate a streamlined pathway to market.