Gyrolab Spin Blog

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


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.

Read More

Topics: Immunoassay, Vaccine

Apr 6, 2020 8:18:44 PM

How to think about HCP impurity testing

Getting a meaningful result

How to think about HCP impurity testing

Many good points were raised when it comes to impurity testing at the latest Gyrolab User Seminar, held in Milan in June. This included a roundtable discussion on a subject that has been a stumbling block for many – how to measure Host Cell Protein (HCP) levels in a meaningful way.

Read More

Topics: HCP, Immunogenicity, Impurity testing

Apr 6, 2020 8:18:21 PM

Enhancing the productivity of immunoassays: a 2-plex Gyrolab® assay for both preclinical and clinical studies

Target-specific reagents and immunoassay formats smoothen validation and transfer between CMC, preclinical, and clinical applications, and also to a CRO

Enhancing the productivity of immunoassays: a 2-plex Gyrolab assay for both preclinical and clinical studieRobust, accurate, precise, and time effective ligand binding assay platforms are crucial for the development of advanced bioassays for analyzing therapeutic antibody mixtures due to the inherent complexity of these drugs. This is why Symphogen A/S, Denmark chose Gyrolab system to develop assays to support chemistry, manufacturing, and controls (CMC) release and stability programs, and pharmacokinetics preclinical and clinical studies on Sym015, a novel anti-cancer biotherapeutic comprising two humanized monoclonal antibodies (mAbs).

Read More

Topics: Pharmacokinetics, Clinical trial, Preclinical studies, CRO transfer

Feb 27, 2020 4:21:35 PM

How to be confident in immunoassay determination of free versus bound target or drug

It’s all about maintaining equilibrium

It’s all about maintaining equilibriumImmunoassays must be able to generate accurate and precise quantitative measurements of analytes such as drug candidates and their targets, and many studies also demand the accurate determination of levels of free or bound drug, or target. Achieving this is a challenge and success depends on many factors, including taking steps to maintain the equilibrium formed in vivo between various molecular forms of the analyte. This can be achieved with care in sample preparation, and by using an immunoassay platform that requires minimal sample dilution, and delivers results quickly before the equilibrium can shift.

Read More

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.

Read More

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.

Read More

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 use

Fast immunoassay validation with high-quality data


With 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.

Read More

Topics: Assay Development, Regulated bioanalysis, Immunoassay

Jan 15, 2020 7:35:53 AM

Putting a new spin on immunoassays for cell and gene therapy – Part 2

Careful platform choice generates data with higher quality to support DOE


Putting a new spin on immunoassays for cell and gene therapy – Part 2Harnessing the power of cell and gene therapy involves a large range of analytical methods that can deliver robust results to support rapid data driven decision-making. One assay development team has used immunoassays to track a transgene IgG product. Their choice of immunoassay platform enabled them to generate high quality data that supported Design of Experiments to quickly optimize cell culture.

Read More

Topics: Assay Development, Gene therapy, Gyrolab system

Jan 15, 2020 7:35:35 AM

Putting a new spin on immunoassays for gene therapy – Part 1

How to detect vector immunogenicity 24× faster and with 10× less sample


Putting a new spin on immunoassays for gene therapy – Part 1Cell and gene therapy promises to revolutionize medicine by correcting underlying genetic causes of disease or conferring new functions to cells to combat disease and has already seen spectacular successes in health care, ranging from curing rare eye diseases, to the treatment of sickle cell disease and a number of cancers. Immunoassays can be important analytical tools in cell and gene therapy and the careful choice of an immunoassay platform can improve productivity by boosting workflows, data quality and greatly reducing the consumption of precious samples, for example in detecting antibodies against lentivirus vectors that are commonly used in cell and gene therapy.

Read More

Topics: ADA, Gene therapy, Gyrolab system

Jun 11, 2019 2:37:58 PM

Next generation antibody therapeutics move into prokaryotes

Smaller, simpler biotherapeutics pave the way for new production methods


Exploiting the advantages of E. coliMammalian expression systems have driven the rise of biotherapeutics. Their ability to introduce proper protein folding, post-translational modifications, and product assembly means that they are currently used to produce almost all therapeutic antibodies to ensure correct structure and minimize the risk of immunogenicity. But the advent of smaller, simpler biotherapeutics means that prokaryote expression systems such Escherichia coli (E. coli) are playing a new role in antibody therapy. These bacteria can deliver high expression levels, with simpler bioprocessing at a lower cost together with an extensive molecular toolbox based on well-characterized genetics. This development is increasing the need for sensitive methods to monitor bioprocess development and manufacturing based on E. coli-based expression systems, including the sensitive analysis of host cell proteins. 

Read More

Topics: HCP, Impurity testing, Gyrolab system, Host Cell Proteins