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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

Application note

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.

eBook

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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

Pre-Clinical and Clinical Drug Testing Information

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.

Pharmaceutical QA/QC Information

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.

Pharmaceutical Data Management Information

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.  


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