Avastin Biosimilars
Avastin (bevacizumab) is a humanized monoclonal antibody that inhibits angiogenesis. By limiting the growth of new blood vessels, Avastin can cut-off the supply of nutrients to malignant cells in a growing tumor.
Avastin is effective against a range of cancers, but the therapy is expensive. Therefore, there is significant interest in Avastin biosimilars to make treatment more accessible. However, overcoming technical challenges and navigating the complex regulatory landscape can slow the characterization and development of new biosimilars.
Sartorius has an extensive portfolio of both off-the-shelf and tailored assays to support the development of Avastin biosimilars. These services allow you to speed up and enhance the reliability of your biosimilar manufacturing process. Our characterization solutions include Avastin binding assays, bioassays, physicochemical and structural analyses, and cell line development.
Sartorius delivers pre-qualified, integrated characterization and comparability packages to support the development and production of Avastin biosimilars.
Uncover valuable insights into your biosimilar
Accelerate development times
Meet regulatory requirements
Boost confidence in your product
Characteristics of Avastin
The progression of malignant cancers is highly dependent upon the process of angiogenesis. The creation of new blood vessels is necessary to provide a continuous supply of nutrients and oxygen to the proliferating cells, allowing the tumor to grow and spread.
Angiogenesis inhibitors – like Avastin - block the formation of new blood vessels and stop or limit tumor growth. Several of these inhibitors are used in cancer therapy, either as a stand-alone treatment or in combination with other drugs.
Avastin is currently approved for use in the treatment of a variety of solid tumors, including colon, breast, cervical, and non-small-cell lung cancer.
Avastin exerts its anti-angiogenic activity by binding to soluble vascular endothelial growth factor (VEGF), a signaling protein that promotes the growth of new blood vessels. VEGF is important in normal physiological processes such as embryonic development or wound healing.
Avastin prevents circulating VEGF from binding and activating its receptors (VEGFR). When bound, these receptors dimerize and are activated by phosphorylation. This begins a cascade of intracellular signaling that stimulates angiogenesis. Therefore, by blocking VEGF signaling, Avastin disrupts the supply of oxygen and nutrients to the growing tumor.
Our Avastin biosimilar characterization solutions provide you with a thorough analysis of your product, helping you prepare for regulatory approval.
Physicochemical and structural assays reveal detailed insights into the composition of your biosimilar
Binding assays quantify and evaluate the binding of your biosimilar to VEGF and other components of the immune system.
Our functional assays measure the biological activity of your Avastin biosimilar against VEGF and other immune pathways.
Assay Types
Physicochemical and structural characterization is a crucial step in determining the potential biological activity, stability, and safety of your biosimilar.
Our versatile platform of physicochemical methods provides the basis for your comparability study. With options suited for clone selection through to formal comparability, we can build detailed insights into the properties of your biosimilar.
The combination of our off-the-shelf physicochemical and structural analyses and our binding and bioassays allows you to evaluate the structure-function relationship and ticks the regulators' box for orthogonal comparability.
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Bioassays provide the means to directly assess the fundamental biological activity of your Avastin biosimilar. As such, they represent a significant component of a product characterization study.
Sartorius can perform an Avastin neutralization bioassay, which measures the affinity of your biosimilar to VEGF. We utilize a reporter assay to generate a robust signal and provide excellent comparability data.
Reportedly, Avastin is unable to cause antibody-dependent cell-mediated cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC). However, regulators require studies that demonstrate a lack of function comparable to the innovator product. While it is often challenging to prove a negative, Sartorius has developed a robust approach to report a negative result with appropriate levels of confidence using our off-the-shelf lack of function assay, which has been verified as acceptable to regulatory authorities.
If you require an Avastin bioassay method that is not listed, please contact us.
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Binding assays play a vital role in characterization and comparability studies. Our assays measure the binding of Avastin to VEGF as well as C1q, the Fc Gamma Receptors (FcR), and the neonatal Fc Receptor (FcRn).
VEGF Binding Assays
VEGF binding assays can be performed using several different assay platforms. VEGF is present in various size isoforms, and binding to each should be assessed as part of a thorough comparability exercise. Sartorius has developed the following Avastin VEGF binding assays:
VEGF Binding ELISA - Our competition ELISA demonstrates Avastin biosimilar binding to VEGF 121a, 189, and 165.
Cell-associated VEGF Binding ELISA by Electrochemiluminescence (MSD) - Sartorius offers Avastin VEGF binding assays using an upgraded version of the traditional ELISA on the Mesoscale Discovery (MSD) platform. This assay reports the relative binding of your biosimilar and innovator Avastin material to cell-associated VEGF as a percentage of a designated reference lot with comprehensive parallelism assessments.
Avastin VEGF Binding by SPR - Utilizing SPR technology offers an enhanced VEGF binding assay that significantly increases the understanding of binding during comparability studies. Our SPR assays for VEGF 111, 121a, 165, and 189 isoforms report full kinetic analysis, including Affinity Constants (KD), with the association or "on" rate (Ka) and dissociation rate (Kd) or "off" rate. The data is also evaluated to generate relative binding and parallelism assessments.
Fc-Receptor Binding Assays
The Fc-Gamma Receptors (FcR) are members of the immunoglobulin super-family and may play a critical role in Avastin's function.
The following Avastin FcR assays are available as pre-qualified solutions using SPR technology.
Avastin Fc-Gamma Receptor I (FcRI)
Avastin Fc-Gamma Receptor IIa (both R and H variants) (FcRIIa)
Avastin Fc-Gamma Receptor IIb (FcRIIb)
Avastin Fc-Gamma Receptor IIIa (V) (FcRIIIa V)
Avastin Fc-Gamma Receptor IIIa (F) (FcRIIIa F)
Avastin Fc-Gamma Receptor IIIb (FcRIIIb)
Additionally, we offer off-the-shelf assays for the neonatal Fc receptor (FcRn) using SPR, and C1q (using ELISA or SPR) to complete our comprehensive Fc comparability package. C1q is the first mediator of the classical complement system, and thus helps to determine the initiation point for complement-dependent cytotoxicity.
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