Lot release testing is an important part of making biopharmaceuticals because it makes sure that every batch meets quality standards for patients. Physicochemical tests can confirm structure and purity, but they can’t fully measure biological activity. To ensure manufacturing lots are consistent, effective and patient-safe, functional evaluation is crucial.
Product performance in a biological system is measured by a biological assay. It measures the bioactivity directly. Such assays further confirm that each manufactured lot produces the intended biological response, detecting small variations that may occur due to changes in manufacture, formulation, or scale-up that other analytical methods may not detect.
Biological assays have become quite important for showing that products are similar and that they are under control as regulatory expectations change. They give useful, mechanism-based proof that backs up release decisions, makes quality assurance processes stronger, and makes sure that every lot works as planned throughout its life.
Find out how biological assays improve lot release methods and keep product performance high in every manufacturing batch.
Biological assays, often referred to as functional assays, evaluate a biopharmaceutical’s ability to produce its intended biological effect. Instead of just looking at structure they look at activity in a biological system, which helps show that every manufactured lot is the same and works as it is designed to do.
Unlike analytical tests that focus on purity, identity or concentration, biological assays capture functional performance. They reveal changes that may not be detectable through physicochemical methods such as shifts in potency or receptor engagement which are required to demonstrate therapeutic consistency and lot release decisions.
Biological assays confirm that each lot released has the same therapeutic effect. By directly measuring biological activity these assays provide functional assurance beyond structural testing, supporting patient safety, clinical reliability and regulatory confidence throughout the product lifecycle.
Physicochemical testing confirms identity, purity, and structural integrity but it cannot fully predict biological performance. Using biological assays in conjunction with physicochemical assays provides an integrated control strategy which captures molecular characteristics and their behaviour in vivo, enabling confidence in lot release decisions.
Precision Antibody offers high-quality biomarker antibodies with efficacy for regulatory support and lot release assays. Their experts align assay design with mechanism of action and product risk to help ensure consistent potency, functional integrity, and reliable batch-to-batch performance throughout the product lifecycle.
Collaborate with Precision Antibody to enhance your lot release strategy with biologically meaningful assays that ensure product quality and patient outcomes.
Q1: What types of biological assays are most commonly used for lot release?
Cell-based potency assays, binding or receptor engagement assays, and enzymatic activity assays are the most frequent biological tests used to release lots. Cell-based assays are often the best choice since they show how something works. Binding assays are utilized when functional activity can be consistently linked to biological performance.
Q2: How do manufacturers decide which biological assay is appropriate for lot release?
The type of assay that is used relies on how the product works, how important it is to patients, and how risky it is. Regulatory guidance favours assays that best reflect in vivo activity, meaning cell-based or functional assays are prioritised when binding alone cannot sufficiently predict therapeutic effectiveness or identify considerable lot-to-lot variation.
Q3: How long does it take to develop and validate a biological assay for lot release?
It usually takes several months to develop and validate a biological assay, depending on how sophisticated the assay is, how much it varies and what the rules specify. Cell-based assays often take longer since they need optimisation and robustness studies. On the other hand, simpler functional assays may move faster if the mechanism is well understood.
Led by innovative minds in immunology and the antibody development field, Precision Antibody has been an industry leader for over 20 years. We not only implement a cutting-edge technique in antigen design, antibody development, production, and other analyses, but we are also constantly working on ways to improve and advance technology to match the ever-changing world of science. If you are interested in learning more about Precision Antibody’s Custom Antibody development.
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