Analytical & Quality Control

At Elise Biopharma, we recognize that precise analytical testing and stringent quality control form the cornerstone of successful biomanufacturing. Whether we’re validating a new therapeutic enzyme or scaling up a commercial product, every batch is subjected to robust analytical protocols. Our commitment to excellence is evident in our state-of-the-art instrumentation, in-house expertise, and adherence to global regulatory standards—ensuring that your product not only meets but exceeds the most demanding specifications.

Comprehensive Analytical Tools and Techniques

  1. UHPLC (Ultra-High Performance Liquid Chromatography)
    • High Resolution & Throughput: Utilizing UHPLC enables faster run times and higher resolution compared to traditional HPLC, making it ideal for protein quantification, peptide mapping, and detecting post-translational modifications.
    • Multiple Detection Modes: Our UHPLC systems can be coupled with various detectors—UV/Vis, fluorescence, or refractive index—to precisely characterize complex biomolecules and impurities.
  2. Spectrophotometry
    • Broad Range Analysis: UV-Vis spectrophotometry supports everything from protein concentration assessments (e.g., Bradford, BCA assays) to enzyme kinetics studies under tightly controlled temperature conditions.
    • Kinetic Measurements: Temperature-controlled spectrophotometers allow us to accurately measure enzyme activity and reaction rates, providing critical insights into performance and stability.
  3. qPCR (Quantitative Polymerase Chain Reaction)
    • Genetic Stability & Contamination Control: By quantifying DNA or RNA in real time, qPCR helps ensure that no unintended microbial or viral contaminants compromise product quality.
    • Strain Verification: This technique confirms the identity and genetic integrity of recombinant strains, vital for products requiring strict traceability.
  4. TOC (Total Organic Carbon) Analysis
    • Water Quality & Process Monitoring: TOC analysis monitors the purity of water used in production processes (e.g., cleaning, media preparation), ensuring minimal organic contamination.
    • Regulatory Compliance: In line with pharmaceutical and diagnostic regulations, TOC helps verify cleanliness of equipment surfaces, reducing cross-contamination risks.

Rigorous Quality Standards & Regulatory Alignment

  • ISO 13485 & ISO 9001 Certified
    Our quality management systems (QMS) encompass detailed standard operating procedures (SOPs), thorough documentation practices, and regular audits to maintain consistent, reproducible results. This certification underscores our commitment to medical device quality management and general industry best practices.
  • FDA Registered
    As an FDA-registered facility, Elise Biopharma adheres to current Good Manufacturing Practices (cGMP) and other critical regulatory guidelines, ensuring that all products and processes align with stringent U.S. standards for quality, safety, and efficacy.
  • Data Integrity & Traceability
    All analytical data is meticulously recorded and managed within secure systems, allowing for complete traceability from raw materials to finished product. Our team leverages electronic laboratory notebooks (ELNs) and, where applicable, laboratory information management systems (LIMS) to streamline data capture and review.

Testing & Validation Excellence

  1. Gel Electrophoresis
    • Protein Characterization: We employ SDS-PAGE, Native PAGE, and specialized techniques (e.g., Western Blot) to confirm the molecular weight, purity, and structural integrity of proteins or enzymes.
    • Identity Verification: By comparing band patterns to known standards, we can rapidly confirm protein identity and detect potential degradation or aggregation.
  2. Multichannel Plate Reader
    • High-Throughput Screening: Our advanced plate readers enable rapid, simultaneous analysis of multiple samples, ideal for activity assays, ELISAs, or colorimetric tests.
    • Kinetic & Endpoint Measurements: We can monitor changes in absorbance or fluorescence over time to gather critical data on reaction rates, enzyme activities, and product stability.
  3. Method Development & Validation
    • Custom Protocols: For unique or proprietary molecules, our expert analytical scientists develop bespoke methods to guarantee accurate and reproducible results.
    • ICH Guidelines: All validation activities—specificity, linearity, accuracy, precision, and robustness—are conducted under ICH and GMP frameworks to ensure international regulatory acceptance.

Why Choose Elise Biopharma for Analytical & Quality Control?

  1. Cutting-Edge Technology
    We continually invest in advanced instruments and software, staying on the leading edge of analytical innovation to enhance both speed and reliability.
  2. Expert Team
    Our analytical chemists, microbiologists, and quality professionals bring decades of collective experience in pharmaceuticals, biotech, and diagnostics—offering deep technical knowledge and problem-solving capabilities.
  3. Regulatory Compliance Focus
    From method development to final product release, every stage undergoes rigorous oversight to meet ISO, FDA, and other global requirements. We proactively update our protocols to reflect evolving regulatory landscapes.
  4. Customized Solutions
    Whether you need a one-time assay or an ongoing quality testing partnership, our flexible workflows can be tailored to match your product’s complexity, lifecycle stage, and market objectives.
  5. Seamless Integration
    Our analytical and quality teams collaborate closely with fermentation, downstream processing, and manufacturing departments, ensuring continuity and minimizing turnaround times.

Partner with Elise Biopharma

At Elise Biopharma, advanced analytical methodologies and unwavering quality control are the bedrock of our success—and yours. Whether you’re developing a novel therapeutic enzyme, scaling up a biologic, or perfecting a diagnostic reagent, our suite of capabilities can be customized to support your goals.

Ready to elevate your project’s quality and compliance?
Reach out to our analytical and quality control specialists to learn more about our services, request a detailed quote, or schedule a consultation. Elise Biopharma is dedicated to forging lasting partnerships that inspire confidence and drive innovation—every step of the way.