Biopharmaceutical
- Accuracy and Precision: Providing reliable data essential for regulatory submissions.
- Comprehensive Characterization: Offering detailed insights into the structure, function, and purity of biopharmaceuticals.
- Quality Control: Ensuring continuous quality monitoring of biopharmaceutical products throughout their lifecycle.
Biopharmaceuticals (biologics) are drug products derived from biological sources, including proteins, antibodies, nucleic acids, and live cells used for therapeutic purposes. Biopharmaceutical analysis encompasses the characterization, quantification, and quality control of these biologics to ensure their safety, efficacy, and consistency. This analysis provides detailed information on structural characterization (primary, secondary, tertiary structures), post-translational modifications (such as glycosylation and phosphorylation), purity and impurities, quantification of active ingredients, potency and bioactivity, stability and degradation products, and immunogenicity. The primary goal of biopharmaceutical analysis is to ensure the therapeutic effectiveness and safety of biologics. This process also guarantees product consistency and quality, regulatory compliance, understanding of mechanisms of action, improvement of drug formulations and delivery systems, monitoring of batch-to-batch variations, and detection and quantification of impurities and contaminants.
Services at MtoZ Biolabs
MtoZ Biolabs offers comprehensive biopharmaceutical analysis services utilizing chromatography (HPLC, UPLC, SEC), mass spectrometry (MS), electrophoresis (SDS-PAGE, IEF), and spectroscopy (UV, IR, CD). These services provide critical data for various aspects of biopharmaceutical development and regulation, including bioassays, quality control, process optimization, product development, and clinical trials. Our biopharmaceutical analysis services include, but are not limited to:
Identification of Biopharmaceuticals
Biopharmaceutical Purity Analysis
Biopharmaceutical Variation Analysis
Service Advantages
Applications
Drug Development: Supporting the development of new biologics from discovery through to commercialization.
Quality Assurance: Ensuring consistency and quality during biopharmaceutical production.
Regulatory Submission: Providing the necessary data for regulatory approvals.
Clinical Trials: Supporting the analytical needs during clinical trial phases.
Post-Market Surveillance: Ensuring the ongoing safety and efficacy of biopharmaceuticals after they have been approved for the market.
Deliverables
1. Experimental Procedures
2. Relevant Mass Spectrometry Parameters
3. Detailed Information on Biopharmaceuticals
4. Mass Spectrometry Images
5. Raw Data
Biopharmaceutical analysis is a crucial component of the biopharmaceutical lifecycle, essential for ensuring safety, efficacy, and regulatory compliance. With extensive experience in biopharmaceutical analysis, MtoZ Biolabs is well-equipped to provide the necessary support and services. For further consultation, please contact us.
How to order?
