The previous blogs in our collaboration with the team at RoukenBio – the Immunology CRO redefined – have focused predominantly on the biological aspects of bioassay development. Including aspects such as cell selection and and DOE, we have been answering important questions about ensuring that the biological response in our assay is present, that it…
When we discuss the performance of a vaccine, properties such as its immunogenicity, adverse event frequency, and any correlates of protection are usually among the first to be mentioned. A property which is considered less often is when a patient can expect to be protected after they have received the vaccine. This is known as…
Vaccines are one of the few medical interventions which are regularly undertaken by healthy individuals. As a result, the bar for ensuring the safety of a vaccine is extremely high. It would be difficult to justify administering a preventative vaccine for a disease an individual might contract if that vaccine regularly causes serious side effects…
Bioassays are typically used to measure the properties of a manufactured product to ensure that it is of sufficient quality for use by patients. Inherent in this process is the need to make decisions based on the collected data. Is the potency of the product as expected? Are there any indications of the assay misbehaving?…
Vaccine development often only hits the headlines when there’s a breakthrough clinical trial or final approval. Behind every successful vaccine, however, is a lesser-known stage of research that quietly lays the groundwork: preclinical studies. Don’t be fooled: these early investigations are essential for answering crucial questions which underpin the future of the vaccine. Is the…
In the next part of our ongoing collaboration, the team at RoukenBio take a look at a key decision point early in the lifecycle of a potency assay: what cells to choose. Potency assays rely on cells as their foundation, acting as essential tools for measuring biological activity and ensuring therapeutic efficacy. The choice of…
The earliest stages of the development of any vaccine involve laying out the roadmap for its design and testing. A vast network of interlinked paths from a new idea to a needle in a patient’s arm stretch ahead into the future, each with unique regulatory and ethical implications. Should the vaccine target a certain strain…
If you’ve ever taken a rapid test for COVID-19, then you’ve used an in vitro diagnostic device (IVD). At the start of the pandemic, the only reliable method for determining whether a patient was currently infected with COVID was a slow PCR test which required processing in a lab to return a result. By contrast,…
A bioassay supporting a commercial product often has a lifespan of several years or even decades. Over that time, it is often necessary that the assay be performed in a number of different laboratories for a variety of reasons. And, in each, the same rigorous standards must be held to ensure that the safety and…
Therapies based on monoclonal antibodies (mAbs) are among the most powerful medical technologies to have been developed in recent years. From treatments designed to attack cancer cells and prevent rejection following organ transplants to methods for treating infectious diseases such as anthrax and COVID-19, the applications for mAbs continue to grow. And that’s before uses…
Management of the reference standard over the life of a product is critical to ensuring consistent production of material. We always want to be able to draw a link between a new batch being produced and one that has demonstrated acceptable clinical properties, particularly safety and efficacy. That’s why reference bridging is so vital: it…
So, you’re confident that you’ve got a feasible assay with a well-defined dose-response curve. But bioassays, as we all know, are fickle. The observed responses are sensitive to many factors which can lead to appreciable variability in the experiment and, in turn, a high assay failure rate. An important part of the development phase of…
When scientific a study is evaluated, the sample size is often among the first issues brought up. Whether it’s the number of participants in a study, the number of times an experiment is run, or even the number of people asked to complete an electoral poll, it is well-known that – in general – a…
Vaccines are among the most important technological developments in human history. From the earliest attempts to prevent smallpox by variolation to modern mRNA vaccines built without a virus needing to have entered the development lab, the vaccine has become a vital string in the bow of public health officials. As with all medicines, batches of…
One of the most frequent topics of discussion on this blog has been the correct and optimal utilisation of different classes of statistical models with bioassay data. Most common among these are the four- and five-parameter (4 and 5PL) models, alongside the simple linear model. There is, however, stranger at the feast: the three-parameter logistic,…
Bioassays serve as a method of testing a product: does the latest batch of our biologic have an acceptable potency? To do this effectively, we need to ensure that our test system – the assay – continues to function as it was originally designed. This is crucial as, in the worst case, a flawed assay…
The control: a vital part of any scientific experiment. The only way to establish causality between the dependent and independent variables in an experiment is by comparison with a control. Controls are also important for establishing detection background: what does “nothing” look like on your sensor? Bioassays are no different: including control wells in your…
The idiom “to pull oneself up by their bootstraps” originated in the late 19th century. At first, it implied impossibility, but has since shifted to mean advances achieved through grit, determination, and hard work, often in business or in one’s career. Thankfully, the statistical method – bootstrapping – named for the idiom rarely requires such…
In bioassay analyses, there are three statistical models that are commonly fit to dose-response data: the linear model, the 4PL model, and the 5PL model. We’ve examined the properties of the 4PL model in great detail previously, and the time has come to give the 5PL model a similar treatment. The 5PL model is the…
Enzyme-Linked Immunosorbent Assays (ELISA) are a key tool for determining concentrations, forming a key component of many fields in the life sciences. From testing food products for allergens to detecting HIV in a patient’s blood and beyond, ELISA analysis is a vital component of a scientist’s arsenal. Quantics has been at the forefront of research…