Profacgen, a state-of-the-art protein service provider offering custom protein services in the biological sciences, now provides immunogenicity testing services to help its customers to accelerate their drug discovery and development programs.
Immunogenicity testing is a key part of biopharmaceutical development. More stringent regulations regarding immunogenicity assay performance require the development of assays that exhibit excellent sensitivity, precision, free drug tolerance, and minimal matrix effect. Immunogenicity assays can be used to detect and confirm anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) that support nonclinical and clinical studies.
Immunogenicity determination can be challenging due to interference originating from the sample matrix, drug interference, or target interference. In order to design a reliable immunogenicity assay, it is very important to start with a suitable assay platform and high-quality reagents. There are two main strategies based on biosimilarity immunogenicity procedures using a single assay or two separate assays.
Based on its GLP-compliant service laboratories, Profacgen participated in an international workshop and developed an R & D program to lead the latest developments in the field. Now Profacgen supplies the following immunogenicity testing services:
Ligand Binding Assay
Cell Based Assays
Total Antibody Assay
Neutralizing Antibody Assay
Particle Size Characterization
Critical Reagent Characterization
Protein Aggregation Analysis
“Our immunogenicity team has developed and validated in vivo and in vitro assays for many of our customers to screen and quantify immunogenicity caused by anti-drug antibodies and impurities. Our team of scientists will work closely with you to develop a custom panel of immunogenicity assays.” Commented Crystal, the chief marketing staff at Profacgen.
For drug development, Profacgen also provides Biopharmaceutical Process and Product Related Impurities Analysis, Biosimilar Testing Services, Induced Protein Degradation, PROTAC Discovery and Development, and Stability Analysis Services. To know more details about those services, please visit https://www.profacgen.com/drug-development.htm.
An innovative design utilizing a more adaptive approach in clinical trials had been discussed by FDA under CPI in 2006.
Since then, different innovative and adaptive designs in Clinical studies have been proposed and implemented.
These designs provide more flexibility as they allow adaption in a trial according to the accumulated results.
Some of these designs are:
Continual reassessment method: This design is used to identify maximum tolerated dose by combining all collected trial data with the data from the past trials.
Sample size re-estimation design: This design allows the reassessing the sample size of an ongoing clinical trial to get the required statistical power.
Clinical Decision Support System Market SnapshotClinical Decision Support System (CDSS) Market is a vital piece of the healthcare IT spectrum, the technology is gaining traction in healthcare systems around the world.
CDSS deployment facilitates faster decision-making, managing data and higher workflow efficiency in patient care.
The versatile functionalities of such systems are playing a major role in driving their popularity.
In 2017, the market for CDSS was valued at over USD 890 Mn and the figure is likely to double by the year 2023.
The Increasing important of data-driven technologies in the healthcare sector is supporting the growth of the CDSS market worldwide.
Other factors that are expected to influence growth trends of the market during the projection period include the rapid expansion of the healthcare sector in fast-developing countries, increased patient influx and the growing global geriatric population.The “Clinical Decision Support System Market” In-Depth competition analysis of the major companies in the report, sector of the report includes the market depictions, requirements, and product portrayals, manufacture, competence, contact figures, cost, and revenue.The Clinical Decision Support System Market provide valuable insight with an emphasis on the global market including some of the major players such As, Cerner Corporation, Meditech, Epic Systems Corporation, Athenahealth, Inc, Allscripts, Carestream, Agfa-Gevaert Group, Elsevier B.V., Hearst health and Wolters Kluwer HealthIndicates the region and segment that is expected to witness the fastest growth as well as to dominate the market Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region.
