Shanghai Medicilon Inc.

Biologics have become a core component of many treatment strategies for rheumatic inflammation. Scientists often consider that immunogenicity is the important limiting factor in the early stages of development of biological agents. However, theoretical guidance is relatively limited and the determination methods for measuring immunogenicity are complex, making the development of past research difficult. But now, the emergence of biosimilars has sparked new interest in immunogenicity, the development of more accurate and convenient testing methods, a greater understanding of the pharmacokinetic results of immunogenicity, and comprehensive and specific guidelines from regulators. Rheumatologists’ overall understanding of the field has greatly improved, including  the factors that cause the immunogenicity, the potential clinical consequences, and the impact on daily treatment. All biological agents are immunogenic and many pathways affect their bioavailability, including patient-speci...

  Immunogenicity testing   is focused on the detection and characterization of anti-drug antibodies (ADAs) and the determination whether these ADAs are neutralizing antibodies(NABs), as NABs may affect the   pharmacokinetics   (PK) of the drug.  It is clear however that animal studies are not considered relevant to predict immunogenicity in humans. Still, the selection of the mini-pig to explore their possibilities for immunogenicity testing of biopharmaceuticals, especially to assist in the interpretation of   safety studies , is based on the improved knowledge that various physiological aspects of Göttingen Minipigs® resemble more the human situation than other animal species.  It is expected therefore that in the near future the safety testing, including immunogenicity testing of biopharmaceuticals in mini-pigs will increase as an alternative for non human primate studies, which use will be limited or restricted. Immunogenicity Services Screening as...

  With flu season rapidly advancing, attention will shift to what novel ideas scientists have developed to protect public health. Now, it would seem investigators at the Dana-Farber Cancer Institute are looking to take the lead in this critical discussion because they have recently published data on the discovery of a new type of immune antibody that can evolve rapidly to neutralize a broad range of influenza virus strains—including those the body hasn’t yet encountered. The revelation of the body’s ability to make the adaptable antibody suggests potential strategies for creating improved or even universal influenza vaccines.                   ❖      Medicilon’s Antibody Development Technology Service Medicilon's antibody development technical service discount covers the full line of  ADA antibody development technical services  and druggable antibody development technical services. The 20% off discount appl...