Biosimiliars Laboratory Services

Biosimiliars

Uncover the world of Biosimilars essential alternatives to existing biologic medicines offering similar therapeutic properties at a reduced cost. These biopharmaceuticals are pivotal in enhancing patient access to treatment for chronic and life-threatening diseases by providing more affordable options without compromising on efficacy or safety.

Biosimiliars Testing and Research Services

Contract Laboratory can help you with all your Biosimiliars testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:

Comparative Analytical Characterization: To demonstrate similarity in structure and function to the reference product
Clinical Efficacy and Safety Studies: To confirm that there are no clinically meaningful differences in efficacy and safety
Immunogenicity Testing: To assess the potential for immune response
Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: To compare the biosimilar's and the reference product's bioavailability and effect on the body
Stability Testing: To ensure product quality over time

Type of Biosimiliars Products

Contract Laboratory can assist your company, academic institution, government agency or organization in outsourcing contract laboratories to perform testing, analysis, and product development for many Biosimiliars finished products, processes, systems, in-process materials, raw materials and components such as:

Monoclonal Antibodies: For autoimmune diseases cancer and chronic conditions
Erythropoietins: Used in treating anemia particularly associated with chronic kidney failure
Insulin Biosimilars: For diabetes management
Granulocyte Colony-Stimulating Factors (G-CSF): For neutropenia and aiding in the recovery of immune system after chemotherapy
Human Growth Hormones: For growth hormone deficiencies in children and adults
Interferons: Used in the treatment of multiple sclerosis and hepatitis C
Follitropins: For fertility treatments
TNF inhibitors: For rheumatoid arthritis psoriasis and other autoimmune conditions
Biosimilar Infliximab: For autoimmune diseases including rheumatoid arthritis and Crohn's disease
Adalimumab Biosimilars: For treating various inflammatory conditions

Biosimiliars Test Methods and Standards

Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Biosimiliars test methods, standards, procedures or specifications.

USP 129 - UAnalytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
ANSI 0001.1-2015 - Standardization of in vitro Assays to Determine Anthrax Toxin Activities
ANSI ASN-0002: - Authentication of Human Cell Lines: Standardization of STR Profiling
ASTM F895-11(2016) - Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ASTM E1564-00(2019) - Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials

Need Biosimiliars Testing or Scientific Research Services?

We can help with all your Biosimiliars lab testing and scientific research needs! Call 1-855-377-6821 or

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