Analytical characterization of complex modalities like viral vectors is a significant challenge. For example, viral vectors can be unstable, which can make production difficult. Scientists are increasingly using viral vectors in clinical trials to evaluate gene therapies, oncolytic therapies, and vaccine applications.
Developing safe and efficacious therapies requires reliable analytics. Adenovirus (AdV) and adeno-associated virus (AAV) are two of the most widely used vector systems in clinical trials. For each process step, scientists need to analyze total virus particles, virus genomes, and virus functionality, as well as host cell protein and DNA impurities. Analyzing product quality attributes in the production process can be time-consuming and costly, and it can be difficult to make assays robust and reproducible. The current assays for viral vectors don’t have detection limits low enough for harvest samples. Additionally, the sample matrix can often affect results, and accuracy can depend on the sample’s impurity level.
This presentation describes reproducible and straightforward SPR assays for accurate and efficient Adv and AAV titer analysis using Biacore™ SPR systems. Our Biacore™ assays show strong correlation to existing techniques, but with higher repeatability, significantly reduced hands-on time, and a high degree of automation. Scientists can apply these rapid and reproducible assays in applications from development to quality control.
SPR can have a large impact in later stages of drug development. It’s a sustainable platform that scientists can use from research to FDA-approval for all biologics. With reusable sensor chips and low sample and reagent consumption, SPR can help improve process economy. To show how scientists are successfully applying the technology, I will also share an overview of industry case studies using SPR assays for QC.
Monitoring Host cell proteins during bioprocess development and biologics manufacturing is a critical task often performed using ELISA. Custom process-specific HCP ELISA are typically the preferred method for measuring HCPs. However, it is not always appropriate or practical to generatede novoantibodiesand a customized HCP ELISA. This creates a strong need for robust, ready-to-use, generic HCP assays to support biologics development.
Here we discuss the generation and validation of a generic CHO-specific HCP immunoassay. We describe the overall workflow starting from creation of the representative HCCF as the HCP reference standard, the development of a broad coverage CHO-HCP antibody, use of multiple orthogonal methods (including amino acid analysis, 2D Western blot and 2D DIBE coverage assay, as well as mass spec) for characterization of the HCP coverage. Lastly, we describe validation of the ELISA for in-process samples and final drug substance as well as supply chain management to ensure long-term access to the validated assay components.
Advanced Electrophoresis Solutions Ltd (AES) is a total solution provider in iCIEF and related cutting-edge technologies. AES has been collaborating with leading biopharmaceutical companies answering their diversely urgent needs. AES stays with customers to give supports for their CMC strategy and entire method development cycle.
AES provides critical reagents including high-performance carrier ampholytes for mAb, ADC, bispecific, and fusion protein with a good lot to lot consistency, which saves millions of dollars for our customers for essential QA/QC of commercial products and facilitates file applications to regulatory agencies. AES also offers a critical reagent service to customize reagent/consumables based on customers’ criteria.
AES’ patented capillary diameter transformation technique (CDTT) allows achieving high resolution and highly efficient iCIEF fractionation. CEInfinite automated preparative system solves a bottleneck existing in the application of iCIEF in the biopharma industry. The obtained fractions by preparative iCIEF can be used for downstream analysis such as native protein characterization, reaction study, and peptide mapping. This multifunctional platform can be robust for iCIEF-MS online coupling to perform rapid characterization and charge isomer identification. The high resolving power of iCIEF combined with routine analytical methods becomes a powerful tool for new therapeutic protein discovery, formulation studies, and stability study, etc.
AES’ CEInfinite analytical iCIEF system is utilized for the direct transfer of any existing iCIEF platform methods across product development and QC. Equivalent or better applications performance can be achieved compared to the existing iCIEF instruments. CEInfinite is 21 CFR Part 11 compliant, it is ready to be established as a routine method for protein characterization and purity determination from formulation to manufacturing QC.
Within current industry drive for accelerated drug development, unmet need for rapidly screening native protein and nucleic acid structures still exists. IonDX Inc., has developed an innovative bench-top analytical system IMgenius™ based on atmospheric ion mobility spectrometry. This patented ion mobility spectrometer simultaneously measures five important attributes of biotherapeutics: size distribution, purity, stability, conformation and polydispersity. This two-part video will introduce the audience to IonDX, its mission and demonstrate applying IMgenius™ to analyze AAV serotypes in less than 10 mins.
As biopharmaceuticals are becoming increasingly complex, the data generated with different analytical techniques is increasing in volume and variety. Obtaining the prescient insights scientists need and can subsequently feed into further stages of development has been hindered by the fact that data often comes from disparate analytical systems and is processed by many different disconnected tools.
LC-(UV)-MS data produces some of the most valuable data possible for biotherapeutic research, development, and production. Advanced enterprise data systems allow organizations to curate, interrogate, and faithfully share that information for timely decision making.
There are, however, key questions scientists need to address every day in accessing and exploiting their data. Is a vendor neutral software platform the answer? What are the real benefits, is it compliance-ready, does it really promote collaboration within the lab or the whole organization, and does it offer better integration between the software platforms they already use, or will it be another one on top of the complex data systems and they need to learn to use it?
In this webinar you can learn about how Byosphere, which is built on trusted data processing software from Protein Metrics,can take awaythe pain of processing data from different MS vendor platforms. This in turn smooths the path toinsights, deep queries and visualization of the processed and extracted information with intelligent dashboards.
Get the value out of your complex data by processing it faster,sharing it easily and summarize it for non-experts for GxP environment.
Who should attend?
Biopharmaceutical scientists with an interest in biopharmaceutical characterization by LC--MS, and general analytical development of biopharmaceuticals
People interested in how to get the most out of their data with no extra effort or pain
People interested in optimizing their IT infrastructure to easily access and operationalize all associated data
Transcriptional activity within a cell can be used to evaluate cell response to a ligand or promoter activity within a transgene or plasmid within a cell. Catalent has developed a relative potency bioassay using real-time quantitative reverse transcription (RT-qPCR) in a duplex format to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay utilizes two fluorescent dyes with minimally overlapping emission spectra that allow real-time monitoring of the gene expression of both target and normalizer genes. The assay does not require purification of the mRNA produced by the cells once lysis has occurred. Normalizing the qPCR cycle thresholds (CT) of the target transcript to the reference transcript allows response curve to be generated and compared to a reference standard. The generation of a four-parameter fit curve analysis from raw qPCR cycle threshold data allows for comparison of relative potency and assessment of suitability based on curve parallelism. The assay platform has been used by Catalent to qualify a repeatable, accurate, linear, and specific bioassay for assessing relative potency.