Producers of pharmaceuticals and biologics are challenged to become more efficient in discovering and developing candidate drugs while increasing manufacturing productivity and reducing costs. Advanced instrumental techniques and workflows can help to accelerate the development pipeline and optimize production processes.
Thermo Fisher Scientific has innovative solutions at every stage of the bio/pharmaceutical process; from discovery through to production and QC. Our deep understanding of the challenges faced by producers of medicines allows us to forge partnerships that deliver next-generation drugs to market quicker.
Pharma & biopharma learning center features
from optimized sample preparation to data analysis
This application note discusses the importance of proper sample preparation for mAb subunit analysis and to provide optimized LC/MS conditions to achieve conclusive information on the mass of the subunits as well as for performing middle-down analysis for sequence confirmation.
Ultra high-pressure liquid chromatography has become an important analytical tool for meeting these varied needs for higher throughput. Analytical instrument makers believe that further advances in the technology will enable UHPLC to have an even bigger impact on the pharmaceutical industry.
Accounting for the inherent heterogeneity of monoclonal antibodies is essential to ensure production of consistent and safe therapeutics and, in light of this, there is an array of chromatographic and supporting regulatory systems.
Four simple workflows to allow you to understand the form, site, & variation of glycosylation on biotherapeutic proteins.
Discover our range of products and workflows dedicated to biotherapeutic characterization. From discovery to lot testing, and from aggregate analysis to peptide mapping, we have the solutions you need.
Make sure your QA/QC program is compliant. Download the free eBook, What You Need to Know About Field-Based Material Identification and Authentication for Pharmaceuticals.
Pharma & biopharma learning center subtopics
In recent years biopharmaceuticals (pharmaceuticals manufactured by biotechnological methods) have become successful medicinally and commercially.
Modern drug discovery is the convergence of several scientific disciplines to find new medicines to cure disease or relieve suffering. The pharmaceutical pipeline is filled with approximately 5,000–10,000 drug compounds to only one approved commercially available drug.
In pharmacokinetic studies, bioanalysis method validation is crucial to minimizing random error and systematic bias, which ensures quality of analytical results. Bioanalytical method validation is a controlled procedure that comprises all the vital steps to establish that a certain method is capable of producing accurate, dependable and reproducible results that are appropriate for a specific analytical application.
Modern advances in pharmacology have resulted in increased life expectancy and reduced suffering of patients fighting disease. It is the frail and vulnerable that have come to rely on modern medicines. Consequently, it is paramount that prescribed drugs have the desired therapeutic efficacy, without fear of harmful side effects from impurities. For healthcare systems to provide quality care, prescription medicines must meet regulatory quality assurance standards.
Regulatory inspections of pharmaceutical companies are increasing. Integrated informatics solutions allow you to provide evidence that your GMP processes are validated, that you are using appropriate resources, and that your analytical data are accurate, complete, and consistent. You can be sure that you have full data integrity, processes are managed according to 21 CFR part 11 requirements, and that your audit checklist will satisfy the inspectors.