Gyrolab Spin Blog

Jun 5, 2020 8:16:27 PM

Boosting vaccine development and production in a post-pandemic era with fast, high-performance immunoassays: Part I

Vaccine discovery and development

Vaccine discovery and development 1Vaccines have become key weapons in the fight against infectious disease and as immunotherapies for other conditions including certain cancers and Alzheimer’s disease. Immunoassays in vaccine development play a key role and meeting ever more pressing deadlines means that efficient and flexible platforms are at a premium, especially in times like these, with the COVID-19 pandemic pressing vaccine R&D to the limit. In this two-part series we will be looking at how immunoassays can contribute to vaccine R&D and production.

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Topics: Immunoassay, Vaccine


Jun 5, 2020 8:11:32 PM

Boosting vaccine development and production in a post-pandemic era with fast, high-performance immunoassays: Part II

Vaccine bioprocess development and production

vaccines

Only clean drinking water can match vaccination in its ability to save millions of lives every year. In the case of the ongoing COVID-19 pandemic, the availability of a vaccine is considered a prerequisite for a return to normal life worldwide. But transforming antigens into robust vaccine products is a lengthy process. In the second article of this two-part series we will look at some examples of how immunoassays can play a key role in delivering reliable vaccine bioassay data to support efficient bioprocess development and production to ensure that vaccine production lots meet targets, time and time again.

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Topics: Immunoassay, Vaccine


Feb 19, 2020 4:32:44 PM

Weighing up the advantages and disadvantages of multiplex assays

Weighing up the advantages and disadvantages of multiplex assaysWith the need to increase analytical throughput in biotherapeutic R&D and cell and gene therapy, multiplexing assays can appear to be an obvious approach. There are certainly potential advantages, but also disadvantages and considerable challenges involved in multiplexing immunoassays – assays must be carefully matched to function in the same buffer and in the same analytical range. An alternative approach – to miniaturize singleplex ELISAs and run them in parallel – may be even more attractive.

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Topics: Immunoassay, Multiplexing


Feb 19, 2020 4:31:53 PM

Solutions to immunoassay interference, cross reactivity and other challenges

Solutions to immunoassay interference, cross reactivity and other challengesImmunoassays have become invaluable in the generation of data for preclinical and clinical studies, process development/optimization and manufacture of biotherapeutics, and also for new applications such as determining viral titer in cell and gene therapy. Having confidence in the data based on the accurate and precise determination of analytes in complex matrices means overcoming many challenges. These can include interference that reduces robustness, selectivity and specificity, the poor performance of cross-reacting antibody reagents, and time-consuming methods that threaten time plans. Such challenges can be overcome by choosing the right reagents, using the right approach on the right immunoassay platform to deliver reliable data as quickly as possible.

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Topics: Matrix, Immunoassay


Feb 19, 2020 4:30:03 PM

Improving quality and speed in immunoassay development, validation, and routine use

Improving quality and speed in immunoassay development, validation, and routine useWith R&D returns for large cap biopharma companies falling to the lowest level in nine years (Deloitte, 1), the escalating cost of bringing medicines to market means that the biopharma R&D process must be examined in detail. One important factor is the development and validation of immunoassays that can deliver high quality data efficiently and in a timely manner. Speed and quality are intertwined, and while manual ELISA has been a major workhorse in biopharma R&D, automation is a key factor in speeding up the generation of high quality data with minimum hands-on time, minimum need for re-runs, and using readily validated assays that meet regulatory requirements.

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Topics: Assay Development, Regulated bioanalysis, Immunoassay


May 23, 2019 9:36:37 AM

Fighting the obesity pandemic

Novel approaches include bifunctional peptide-based drugs

 

scale-lowObesity has become a devastating pandemic, with 108 million obese children and 604 million obese adults worldwide in 2015, and the problem is increasing (1). The result is an escalation in serious conditions such as type 2 diabetes mellitus (T2DM), cardiovascular disease, hypertension, dyslipidemia and several cancer forms, mainly gastrointestinal. Obesity is very difficult to treat through life style changes and surgery has become the most effective and long-lasting route to sustained weight loss, although it is only available to a small subset of individuals, and is both costly and risky. The search for more widely applicable treatment has driven the development of peptide-based pharmaceuticals that can meet key challenges of obesity, including control over satiety, blood sugar and LDL cholesterol levels.   

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Topics: solid-phase peptide synthesis, Obesity, Immunoassay, Symphony peptide synthesizer, GLP-1, Diabetes, Gyrolab system


Jul 11, 2018 9:00:00 AM

Does your antibody have the right affinity?

The value of affinity determination in assay development and throughout drug development

Affinity curve

The drive to lower drug dosage, improve healthcare and reduce costs has lead to the search for therapeutic antibodies with high target affinity. As a consequence, optimizing and monitoring the specificity and affinity of drug candidates to the target molecule has become critical in the development of therapeutic antibodies – from early screening of hybridomas or recombinant antibodies from phage display libraries, to affinity maturation and antibody engineering to improve the efficacy, safety and manufacturability of the final antibody drug product. Characterizing affinity is also important when selecting reagents for quantitative assays or assessing drug product activity in manufacturing release tests. The question is, how can high affinity be measured in the best possible way?

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Topics: Pharmacokinetics, Affinity, Affinity in solution, Immunoassay


Apr 25, 2018 2:22:39 PM

How to overcome disease-specific matrix interference

Minimize incubation times with flow-through immunoassays

dropMatrix interference can be a major challenge in the development of immunoassays to study a number of disease states. Kathi Williams and her colleagues at Genentech Inc., USA, experienced considerable problems with matrix interference when developing an ELISA for Phase III studies of a humanized monoclonal antibody when a new patient group was introduced. The solution was to transfer the assay to the Gyrolab platform that, thanks to its flow-through technology helped minimizing matrix effects by reducing the incubation times with the capture reagent antibody.

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Topics: Matrix, Pharmacokinetics, Immunoassay, Clinical trial, Phase III studies, Ulcerative colitis, Crohn's disease