Biologics Manufacturing

Key capabilities

Real-Time Functional Binding Analysis:

Gator BLI provides label-free, high-sensitivity measurements of activity and potency directly from complex matrices.

Quantify Critical Quality Attributes (CQAs):

Confidently assess how well a therapeutic binds and functions to support efficacy, dosing, and regulatory approval.

Confident, High-Throughput Decisions:

Screen multiple drug candidates or formulations quickly using real-time kinetic data at any development stage.

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The most important attribute of any therapeutic molecule is the final result – the biological activity and potency of a therapeutic molecule. Activity and potency are critical quality attributes (CQAs) of any biotherapeutic, including classical monoclonal antibodies, peptides and novel gene therapies. This means measuring how well a drug interacts with its target, how it triggers specific cellular responses, and how effective it is in neutralizing or modulating disease pathways. For preclinical developers, this information helps you predict the molecule’s potential efficacy, dosing regimen, and expected safety profile. For those in biopharmaceutical development, clinical trial support, and regulatory compliance, quantifying these attributes gives you the data necessary to ensure therapeutic success and regulatory approval.

However, evaluating activity and potency can be challenging. When the protein isn’t an enzyme, how do you know that it’s folded properly and binds to its target effectively? How do you know whether it’s active? Moreover, most methods that study binding interactions aren’t compatible with crude matrices, while others require labeling of the proteins of interest. No matter how you slice it, scaling up is always difficult.

Gator Bio’s bio-layer interferometry (BLI) technology allow confident measurement of binding affinity and activity of your drug products. Gator BLI simplifies the analysis of activity and potency by providing real-time, label-free detection of functional binding even when captured out of complex biological matrices. With high sensitivity and the ability to measure kinetic parameters like association and dissociation rates, users can perform high-throughput screening during discovery, and screening of multiple candidates or formulations quickly during downstream process development. At any stage, Gator BLI gives you the tools you need to make the next big decision.

Key capabilities

Fast, Label-Free Protein Quantitation:

Gator BLI enables real-time detection without secondary reagents, ideal for tracking titers in crude or purified samples.

Broad Dynamic Range with Minimal Prep:

Accurately measure antibody and biomolecule concentration across stages of expression, purification, and QC.

Scalable for High-Throughput Workflows:

Run up to 32 samples in parallel to support early discovery, bioprocessing, and clinical assay development with confidence.

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Selective quantitation is the cornerstone of bioprocessing, preclinical research, and clinical assay development. No biologics development, diagnostic, or cell and gene therapy method is complete without a simple, reproducible method for quantitating their therapeutic products at every stage of expression and bioprocessing. Samples don’t always come from clean, purified preparations – researchers also need to be able to measure their protein’s concentration in cell culture supernatant, serum matrix, supernatant, or lysate. Specific protein quantitation is used at every stage, lead candidate selection, dose determination, assay validation and finally, quality control. 

It’s common to measure specific titer multiple times throughput the expression process, meaning that fast, reliable tools are needed for any group that monitors monoclonal antibody expression, biomarker levels, or purification workflows. Any group that’s been stuck doing ELISA for their quantitation protocols has experience with cumbersome protocols, long assay times, high %CV, and lack of flexibility. Other conventional methods require labeled samples or secondary reagents, suffer from limited dynamic range, or are difficult to scale, particularly when working with low sample volumes or crude samples.

Gator Bio’s bio-layer interferometry (BLI) technology simplifies and accelerates antibody and biomolecule quantitation with label-free, real-time detection that eliminates the need for secondary reagents or complex workflows. Gator BLI provides a broad dynamic range and exceptional sensitivity, making it ideal for quantifying proteins across both purified and unpurified samples with minimal preparation. With automation-ready instruments and the ability to run up to 32 samples in parallel, Gator BLI enables researchers to quickly generate high-confidence quantitation data in early discovery, manufacturing, or clinical assay development. Gator Bio delivers fast, accurate, and reproducible quantitation exactly when and where you need it.

Key capabilities

Monitor Yield and Activity in Real Time:

Gator BLI enables label-free quantitation and binding analysis directly from crude bioreactor supernatants—no purification required.

Track Critical Quality Attributes at Scale:

Assess glycosylation, aggregation, and binding kinetics across multiple culture conditions or time points with minimal sample use.

Streamline Bioprocess and CMC Development:

With high-throughput, real-time analytics, Gator BLI empowers teams to fine-tune culture variables and drive consistent product quality.

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The end goal of biologics manufacturing is to produce high-quality therapeutics proteins with consistent yield, purity, and potency. Even after upstream parameters are established, the conditions under which cells are grown in the bioreactor have dramatic effects on the activity of the protein product. Cell culture optimization goes beyond media composition – feeding strategy, culture duration and fermentation time, and harvest timing can have a dramatic impact on critical quality attributes (CQAs) like glycosylation, aggregation, and bioactivity. Moreover, these variables need to be fine-tuned each time the process is scaled up, and they must be accurately tracked and recorded to ensure regulatory compliance, and therapeutic efficacy. For teams in bioprocessing, Chemistry, Manufacturing and Controls (CMC) development, or cell line engineering, optimizing these culture conditions is the key to strong downstream performance and overall product success.

Many techniques that enable this kind of research only answer one question at a time, leaving researchers with disconnected measurements of protein quality attributes, yield and function. Moreover, the cost and time to run these assays often require purification steps and offline analytics, causing teams to lump together all of the assays at the end of the week instead of monitoring progress in real-time, meaning they miss critical timing windows or end up with data that they can’t reproduce, since the sample is used up. All these barriers make it difficult to monitor critical attributes in real time or at scale, especially across multiple culture conditions or time points.

Gator Bio’s bio-layer interferometry (BLI) systems offer a fast, flexible, and sample-efficient approach to cell culture monitoring and optimization. With label-free, real-time analysis, Gator BLI enables users to quantify protein expression and assess functional binding activity directly from crude supernatants, eliminating the need for purification during early optimization. BLI lets you compare the effects of different culture conditions on both protein yield and CQAs like binding kinetics or target specificity. Designed for high-throughput screening and low sample consumption, Gator BLI provides a true all-in-one solution for downstream process development and monitoring.

Key capabilities

Directly Assess Stability and Function:

Gator BLI enables real-time, label-free analysis of binding affinity, aggregation, and activity from unpurified formulation samples.

Simplify Testing Across Formulation Conditions:

Easily monitor stability across multiple buffers, pH levels, and storage conditions without cumbersome prep or labeling.

Support High-Throughput Formulation Development:

Ideal for quality assurance and regulatory workflows, Gator BLI streamlines testing at scale to ensure long-term drug efficacy.

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Medicines are not just wet-lab proteins jammed into a bottle—a properly executed biopharmaceutical development process ensures that biotherapeutics and antibodies maintain their efficacy, safety, and activity throughout their shelf life. To develop good stability, a formulator needs to pay careful attention to buffer composition, pH, concentration, and the presence of stabilizers or excipients in order to evaluate how these factors influence the stability, aggregation, degradation, and bioactivity of the therapeutic molecule at multiple time points and storage conditions. This is the last stop in the development process, and for anyone working in drug development, quality assurance, or regulatory affairs, establishing a stable, effective formulation is an essential step that ensures successful clinical trials and commercial production.

Formulation development and stability testing is often a high-throughput endeavor – each formulation needs to be tested at multiple time points, varying buffer conditions, and diverse storage conditions. When working at this kind of scale and frequency, purification steps and time-consuming testing protocols are a no-go. Moreover, when you’re not working with enzymes, many protocols fail to show the impact of formulation changes on protein structure and function.

Gator Bio’s bio-layer interferometry (BLI) is a fast, efficient way to monitor stability and formulation effects on biotherapeutics and antibodies. With real-time, label-free monitoring, Gator BLI allows researchers to observe protein aggregation, binding affinity, and functional activity directly from formulation samples without the need for purification, tags, fluors or other labels that might cause unwanted immunogenicity. Whatever your formulation or stability needs, Gator Bio provides the tools to ensure that your biologics maintain their efficacy and stability while they get to the patient.

Key capabilities

Quantify Yield and Activity in Real Time:

Gator BLI enables label-free monitoring of protein concentration and binding directly from crude media without cumbersome purification.

Accelerate Media Screening Workflows:

Rapidly evaluate multiple media formulations or feeding strategies with high-throughput, low-volume assays.

Upstream Decisions, Downstream Impact:

Optimize titer, quality, and process efficiency early in development to drive better outcomes in biomanufacturing.

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When developing therapeutic antibodies, recombinant proteins, and other biologics, optimizing the expression media is always a major barrier. The composition of expression media directly impacts cell growth, protein yield, and product quality, so it’s essential to get it right. In both research and industrial settings, optimizing cell culture media can have a dramatic impact on productivity, consistency, the cost-effectiveness of your biologic, and that’s true whether you’re using bacterial, CHO, HEK, insect cell, or other expression methods. Scientists and process engineers are constantly taking titer and activity measurements at every stage of bioprocess development, cell line engineering, or biomanufacturing.

Historically, optimizing these workflows was a slow, resource-intensive, and poorly integrated process. Many labs must rely on indirect or endpoint assays with low reproducibility to assess protein production and activity, delaying the identification of optimal media conditions and increasing the risk of selecting suboptimal formulations.

Gator Bio’s bio-layer interferometry (BLI) systems enable real-time, label-free quantitation of expressed proteins directly from crude media samples. This allows researchers to monitor yield and binding potency simultaneously without purification and without breaking the bank. With its high throughput, low %CV, and small sample volume, Gator BLI makes it easy to screen multiple media formulations or feeding strategies in parallel, allowing scientists to optimize cell media in days instead of months. Whether you’re improving titer, enhancing quality attributes, or fine-tuning upstream parameters, Gator BLI helps scientists make upstream decisions that later translate to downstream success.

Key capabilities

Comprehensive, Real-Time QC Analysis:

Gator BLI provides label-free measurement of binding, potency, and batch-to-batch consistency directly in formulation buffers.

Fast, Simple, and Scalable Workflows:

Minimize sample prep and assay time with high-throughput, low-CV analysis suited for cGMP environments.

Regulatory-Ready Performance:

With 21 CFR Part 11 software and ISO-compliant hardware, Gator BLI is ready to take your CQA validation to the next step.

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Making a good product once isn’t good enough – it needs to be correct every single time. Quality control (QC) is a critical aspect of biotherapeutics development and manufacturing, ensuring that each batch of monoclonal antibodies, recombinant proteins, or other biologics meets rigorous standards for purity, potency, and consistency. QC involves a broad range of tests to assess Critical Quality Attributes (CQAs) such as identity, glycosylation profiles, and functional activity. For teams working in biomanufacturing, regulatory compliance, or clinical trials, establishing a reliable QC process is key to ensuring that products meet the cGMP (current Good Manufacturing Practices) guidelines and are ready for regulatory approval and market release.

Anyone in QC process development knows that QC assays need to be affordable, simple, easy to analyze, and quick to perform. Any assay that requires extensive sample preparation, labor-intensive assays, or has ambiguous %CV doesn’t make the cut. Moreover, without real-time insights into the behavior of the molecules, it’s easy to miss the details. 

Gator Bio’s bio-layer interferometry (BLI) technology addresses these challenges by offering a real-time, label-free solution for comprehensive QC analysis. Gator BLI enables the direct measurement of protein binding, kinetics, and functional activity in final formulation conditions with minimal sample prep. Gator BLI is ideal for testing batch-to-batch consistency and verifying conformational integrity with the kind of clarity that only a real-time device can bring. Gator’s easy-to-use 21 CFR Part 11 software and ISO 9001 compliant instrument manufacturing make it a great choice for any company that needs high-throughput capabilities and the ability to assess multiple attributes simultaneously. Gator’s BLI technology streamlines the quality control process, ensuring biotherapeutics meet regulatory standards and deliver consistent, reliable results.