Jerrycret68

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Statistical Equivalence Analysis

Jerrycret6808 Jan, 2024Technology

What Is Equivalence Analysis? Biosimilars are safe, affordable and effective treatment alternatives as almost an identical copy of its originator. Because of unavoidable differences in the manufacturing processes, a biosimilar is not likely to be entirely identical to the reference product. An equivalence trial should show that the proposed biosimilar has neither decreased nor increased activity relative to the reference product, in other words, neither the biosimilar nor the reference product is superior or inferior to the other.

In Vivo Non-Clinical Studies

Jerrycret6808 Jan, 2024Technology

Biosimilars - An Additional Opportunity for Patients Non-clinical studies is a critical stage in the drug development. As required by several regulatory agencies, it is essential to demonstrate the biosimilar product matches its innovator products in biological similarities including quality, efficacy and safety before initiating any clinical studies.

Stability Characterization

Jerrycret6808 Jan, 2024Technology

Stability Testing Programs Stability studies during biosimilar development are critical along a candidate's road to becoming a commercial drug. Based on the ICH Q5C guidance, the stability analysis tests the potency, purity, molecular characterization, and product characteristics of a biosimilar candidate under various environmental conditions over a specific timeframe. Many factors can affect the stability of biologics and biosimilars, therefore, there is complex analytical methodologies to profile the stability characteristics. A range of studies must be designed to provide assurance of the stability of the product.

Biological Activity Characterization

Jerrycret6808 Jan, 2024Technology

About Biological Activity Characterization Program In addition to physicochemical properties, biological activity characterization is an indispensable part of the biosimilars quality evaluation system. Biological activity characterization is the determination of the content and titer of active ingredients of antibody drugs, which is an important quality control index to ensure the effectiveness of antibody drugs, so it is necessary to establish a complete system for characterization. In general, it includes biological activity assays and binding activity assays. Commonly biological activity assays include: ADCC, CDC, inhibition of cell proliferation, cytotoxicity, cytokine secretion capacity, internalization, etc.

Physicochemical Characterization

Jerrycret6808 Jan, 2024Technology

About Physicochemical Characterization Program Biologics and biosimilars, also known as biotherapeutics, are produced by organisms such as bacteria, yeast, and mammalian cells. The structural characterization of therapeutic drugs is a key factor in ensuring efficacy and patient safety. It mainly includes from primary amino acid sequences to high order structures.

Oncolytic Adenovirus

Jerrycret6827 Dec, 2023Technology

Brief Introduction of Ads Ad, belonging to Adenoviridae family, is a non-enveloped, double-stranded DNA virus with an icosahedral capsid encompassing a linear duplex genome of ~36 kb. Its genome can be divided into early genes (E1A, E1B, E2, E3, and E4) and late genes (L1-L5). Early genes encode corresponding proteins that are expressed early during viral replication whereas late genes are expressed after the commencement of viral replication and encode for capsid proteins. Conveniently, the virion structure of Ads allows the insertion of complementary DNA (cDNA) elements for expression of foreign transgenes to impact their tropism, safety, tumor lysis and so on. The first recombinant adenovirus (H101, one E1B mutant adenovirus) for head and neck tumors' treatment was approved in November 2006 in China.

Oncolytic Virus Construction

Jerrycret6827 Dec, 2023Technology

Adenovirus has been explored and engineered extensively as an oncolytic virus and viral vector for gene therapy to reduce viral virulence and increase efficacy and specificity. E1A gene in adenovirus is responsible for viral replication in tumor cells and needs to be attenuated for oncolytic purpose. Coated protein modification is to increase target specificity of adenovirus to tumor cells, and thus alters viral tropism. Adenovirus can also be modified through transcriptional targeting, such as placing E1A and E1B gene under control of promoter of cyclooxygenase-2 enzyme (highly expressed in a range of cancers), or through post-transcriptional modification, such as targeting of cancer specific miRNA.

Immune Checkpoint Inhibitor-expressing Oncolytic Virus

Jerrycret6827 Dec, 2023Technology

Oncolytic viruses are a group of replication competent viruses which curtail tumor growth. They are able to selectively replicate within tumor cells and lead to cell death while leaving normal cells intact, on account of their natural capacity or via genetic modifications. Oncolytic viruses also can cause tumor cell death through the induction of innate and adaptive immune responses.

Antibody-expressing Oncolytic Virus

Jerrycret6827 Dec, 2023Technology

Recently, recombinant monoclonal antibodies (mAbs) are one of the most powerful therapeutic classes in inflammatory diseases and oncology. However, a broader accessibility and implementation is limited by the high product cost and long-term need for frequent administration.

Immunogenicity Manipulation

Jerrycret6827 Dec, 2023Technology

Nowadays, oncolytic virotherapy has gradually become a powerful immunotherapeutic modality for cancer treatment. However, the anti-tumor effect of oncolytic virus is often limited by the immunogenicity of virus which may induce neutralization antibody to inactivate the virus and decrease viral load in patients.