Comprehensive Bioassay and Quality Control Services
At Profacgen, we understand that accurate protein measurement, protein determination, and protein quantification are the foundation of successful research and bioproduction. Whether you're developing therapeutics, optimizing expression systems, or ensuring batch-to-batch consistency, our analytical services deliver the critical data you need—with clarity and confidence.
Key Features
- Multiple Method Options – Choose the right approach (UV, colorimetric, HPLC, etc.) for your protein's unique properties.
- Regulatory-Ready Data – Fully documented analyses support IND submissions, batch releases, and peer-reviewed publications.
- Expert Guidance – Our team helps interpret results and optimize protocols—because accurate proteins start with smart analytics.
Applications
- Research and Development
Our services are essential in the early stages of protein product development, from discovery to preclinical testing. They provide detailed insights into protein structure, function, and purity, supporting the development of high-quality products that meet regulatory standards. - Clinical Trials
During clinical trials, our bioactivity and potency assays ensure that protein products are safe and effective. This support is crucial for the successful progression of products through the regulatory approval process. - Manufacturing and Quality Control
In manufacturing, our impurity limit testing and stability testing services ensure consistent quality and compliance with regulatory standards. This helps maintain product efficacy and safety throughout production.
Service Procedure
Getting started with our comprehensive bioassay and quality control services is easy. Simply contact us to discuss your specific needs and requirements. Our team of experts will work with you to develop a customized testing plan tailored to your protein product.
Steps to Initiate a Project
Sample Requirements
- Material Options:
- Purified protein (≥85% purity preferred)
- Cell lysate/crude extracts (for early-stage work)
- Gene sequences (for expression optimization or custom production)
- Formulation: In final buffer if available, or standard PBS
- Shipping: Frozen at -80°C (lyophilized accepted with reconstitution protocol)
Deliverables
- Raw + Analyzed Data: Full chromatograms, spectra, and dose-response curves
- Regulatory Support: ICH-compliant reports available
- Formats:
- Summary reports for quick review
- Custom data packages for specific needs
- Timelines: Clearly outlined milestones with regular updates
Key Services Offered
- Protein Impurity Analysis - Ensuring Product Safety
Even the smallest contaminants can compromise protein-based products. Our specialized testing identifies and measures problematic impurities so you can be confident in your product's quality.
What We Detect:
- Host cell protein detection: Using gold-standard methods like ELISA and MS, we find trace HCPs that could trigger immune responses.
- Protein impurity detection: We screen for unwanted protein variants, aggregates, and degradation products.
- Detection of protein contaminants: Our assays catch residual DNA, media components, and other process-related impurities.
- Bioactivity & Potency Testing – Because Function Matters
A protein's true value lies in what it actually does. Our bioactivity and potency assays go beyond simple protein quantification assays to show whether your protein works as intended—critical for R&D, QC, and regulatory submissions.
How We Measure What Matters:
- Cell-Based Bioassays: See how your protein behaves in living cells. These assays tell you if it's biologically active, not just present.
- Enzyme Activity Assays: For enzymes, we measure real catalytic function—not just concentration. Because speed and specificity matter.
- Binding Assays: Confirms your protein engages its target correctly. Essential for validating therapeutics and research tools.
- Keeping Your Protein Products Safe from Microbial Threats
No one wants surprises in their protein preps—especially not the microbial kind. Whether you're in development or production, microbial contamination can ruin batches, delay timelines, and even pose safety risks. That's why our sterility testing and microbial detection services are designed to catch contaminants before they become a problem.
What We Offer:
- Culture Methods: We still use trusted agar plates and broth cultures because they work. These methods catch a wide range of bacteria and fungi—if it's alive and growing, we'll find it. Perfect for standard sterility testing.
- Molecular Detection: When you need to spot hard-to-grow or slow-replicating microbes, we use PCR-based microbial detection. No waiting for colonies—just straight to identifying contaminants by their genetic information.
- Rapid Systems: Our fluorescence and bioluminescence-based systems detect microbial activity in near real-time. Ideal when time is critical but accuracy can't be compromised.
- Will Your Protein Stand the Test of Time?
Proteins can be finicky - what works today might degrade tomorrow. That's where stability testing comes in. We help you nail down shelf-life determination and storage conditions so your protein stability doesn't become an afterthought.
How We Test:
- Accelerated Studies: We predict long-term stability by exposing samples to elevated temperatures, humidity, and light. This accelerates degradation processes and evaluates stability over a shorter period.
- Long-Term Stability Studies: For more accurate data, we conduct long-term studies under real-time conditions. These studies ensure that protein products meet regulatory shelf-life requirements.
- Degradation Studies: We identify and quantify degradation products to understand degradation pathways and enhance product stability.
Case Studies and Examples
Background:
A leading pharmaceutical company was developing a new therapeutic protein product and needed to ensure that it met the required purity standards. Impurity limit testing was crucial for demonstrating the safety and efficacy of the product.
Approach:
We employed a combination of ELISA and mass spectrometry to detect and quantify host cell proteins (HCPs) and other impurities in the protein product. Our customized testing solution provided detailed data on impurity levels, ensuring that the product met regulatory standards.
Results:
The impurity limit testing demonstrated that the protein product was free from significant levels of impurities, ensuring its safety and efficacy. This data was crucial for the successful progression of the product through clinical trials and regulatory approval.
Background:
During clinical trials, a biotechnology company needed to ensure that their protein product maintained consistent bioactivity and potency. Accurate measurement of these parameters was essential for demonstrating the therapeutic efficacy of the product.
Approach:
We conducted a series of bioactivity and potency assays, including cell-based assays and enzyme activity assays, to measure the functional activity of the protein product. Our customized testing solution provided reliable data on bioactivity and potency, ensuring that the product met clinical standards.
Results:
The bioactivity and potency assays confirmed that the protein product maintained consistent therapeutic efficacy throughout the clinical trials. This data was crucial for the successful progression of the product through the regulatory approval process.