The development of a bioassay is, in essence, a long series of choices. An assay which reaches commercial use is the end of a single path through a near-infinite forest of decision points and optimisations. The eventual goal is to produce an assay which is as accurate and precise as possible, while still being practical…
A key decision in the planning of a clinical trial is that of the sample size. As we’ve discussed previously, the number of participants in a trial is key to whether it will provide useful results – specifically whether the trial will have enough statistical power. Simultaneously, the cost and complexity of a trial can…
In the first part of our series examining USP <1033> in depth, we discussed the goals of bioassay validation – specifically, to demonstrate that an assay is suitable for its intended use. Part of this demonstration is a detailed quantification of the accuracy and precision of the assay. We saw how accuracy and precision can…
During the early development of many therapeutic products, analytical and data management processes are often created quickly and pragmatically. Excel spreadsheets, macros, and bespoke code are widely used because they are flexible and allow rapid iteration while assays are evolving. And, since many novel products do not make it past the R&D stage, it rarely…
One can think of the life of a bioassay in two main acts. First comes the design and development of the assay, where the assay method is conceptualised, refined, and optimised. Later, the goal is for the assay to be deployed in a regulated environment to, for example, test batches of product to ensure that…
One common use for bioassays is to test manufactured biologic products before they are released to the wider consumer market. While all bioassays used for this purpose will have undergone stringent testing and validation, it is vital that their ongoing performance is closely monitored to ensure that any changes in the assay system do not…
Statistics is hard, words are harder. So often when working through the statistics behind a bioassay, the correct path is obscured behind a word salad of jargon placed seemingly deliberately to block your passage. Our goal is to make statistics as accessible as possible, which is why we’ve previously examined the different limits one might…
So far in our series examining approaches to outlier management in bioassay, we’ve discussed the various perspectives on outliers held by stakeholders in the bioassay lifecycle and the problems the presence of outliers can pose for an assay system. We then used a simulation to evaluate the performance of a couple of methods for outlier…
Previously, we examined the reasons why one might consider attempting to identify and remove outliers from bioassay data. From a scientific perspective, omitting any collected data is never ideal, but true outliers are not part of the natural variability of the assay so ought not be included alongside legitimate observations. And, as we discovered through…
Outliers are among the topics which stimulate the most vigorous debate among the bioassay community. When a datapoint falls outside of the usual range observed for that metric, it sparks a series of difficult questions. Is that point an outlier, or is it a result of variability? How can we tell the difference? If it…
In many fields of science, researchers often face the challenge of measuring extremely small quantities. The life sciences are no exception, with experiments regularly requiring accurate and precise detections of tiny concentrations of impurities or other substances. Even while analytical techniques have advanced, manufacturing processes have improved in lockstep, meaning the capabilities of the testing…
To perform any experiment, it is vital to ensure that enough data is collected. Too little data can not only mean imprecise results, but also makes distinguishing between reality and statistical fluke difficult. This concept of statistical power – and, inherent within, sample size – is a key component of trial design: consideration must be…
In In Vitro vs In Vivo Potency Assays: Modern Vaccine Batch Release, we examined the pros and cons of two methods of testing vaccine potency: in vivo assays, which use animal models, and in vitro assays, which use laboratory experiments. As we established in that blog, the direction of travel is towards the improved analytical…
One key challenge when developing vaccines for human use is that it is often infeasible or unethical to assess the efficacy of the candidate vaccine directly in humans. As we’ve discussed previously, diseases which are severe, rare, or both are difficult to accommodate in human testing. This poses a quandary: these diseases are often the…
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…