Pharmaceutical & Biopharmaceutical
Progress in medical and pharmaceutical technology is a key driver to increase people’s life expectancy. Nowadays, beside the classical small molecule driven pharmaceutical development, more and more biopharmaceuticals are developed and used for treatment and therapy. This brings up new challenges in diagnostics and analytics.
Modern pharmaceuticals are applied more individual related to patients and illnesses, help to overcome chronic or incurable diseases. Development and production of modern drugs require state of the art analytic.
Shimadzu actively supports life science and biotech research in wide variety of areas such as proteomics, genomics and metabolomics. In addition, we provide analytical instruments that meet the needs of the modern age by helping to manufacture safe pharmaceuticals in compliance with IQ/OQ requirements and other applicable regulations.
From Drug Discovery to Quality Control, Shimadzu’s wide range of solutions supports the pharmaceutical industry through chromatography (GC and HPLC), spectroscopy (UV-Vis, FTIR, AAS, ICP), mass spectrometry (LC-MS, GC-MS), sum parameter (TOC), and MALDI-TOF systems including MS imaging. Shimadzu combines a long history in the market with a comprehensive product portfolio and expertise in regulatory compliance, making the company the perfect partner for the pharmaceutical industry.
The Development Process
Medicinal chemistry is the chemistry discipline concerned with the design, development and synthesis of pharmaceutical drugs. The discipline combines expertise from chemistry and pharmacology to identify, develop and synthesize chemical agents that have a therapeutic use and to evaluate the properties of existing drugs.*
* Helmenstine, Anne Marie, Ph.D. "Medicinal Chemistry Definition." ThoughtCo,
Dec. 5, 2018 thoughtco.com/definition-of-medicinal-chemistry-605881.
Most pharmaceuticals are small organic molecules characterized by lower molecular weight (less than 900 Daltons) and ability to easy enter the cells. They are functioning as regulator, inhibitor or stimulator for metabolic processes. From the pharmacology point of view, small molecules are used in many application fields for a targeted therapy.
One of advantages is, most of them can be taken orally and not require injection or another parenteral administration. Development, Testing and Production are complex processes and require appropriate analytical equipment as well as comprehensive documentation to meet the high level of international standards applied by regulatory bodies.
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Analysis of biopharmaceuticals is a complex task as a variety of substances such as proteins, nucleic acids or sugars or combinations of them have to be analyzed. Dedicated applications and solution systems has been developed for support reserach and routine analysis.
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General issues
Data Integrity
Data integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.
Source: Medicines & Healthcare products Regulatory Agency (MHRA)
- GXP Data Integrity Guidance and Definitions; Revision 1: March 2018
Shimadzu’s solutions support customers to work in regulated environment and to address requirements of compliance and data integrity
Data Integrity Compliance brochure
White paper
Ссылки по теме
- ФГБУ «Научный центр экспертизы средств медицинского применения» Минздрава России
- FDA Issues Guidance for Industry on ANDAs: Impurities in Drug Products
- European Medicines Agency (EMEA)
- Parental Drug Association (PDA)
- International Society for Pharmaceutical Engeneering (ISPE)
- Pharmaceutical Inspection Convention (PIC)
- Food and Drug Association (FDA)
- United States Pharmacopeia (USP)
- International Conference on Harmonization (ICH)