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.

Broad variety of analytical solutions

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.

Latest News

Solutions for Vaccine Testing

Vaccines are biological products that provides active acquired immunity to a particular infectious disease. They are typically made from biological materials and contains an agent that resembles a disease-causing microorganism, often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins.

Research and development of vaccines is one of the challenges to therapy infectious diseases and apply a prophylaxis to stop its spreading. Therefore, beside medical and molecular biology research a fast and high sensitive / specific analytic is required.

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Analysis of Impurities in Sartan-Type Bulk Drug Substances

In July 2018, the American Food and Drug Administration (FDA) announced that the carcinogenic impurities N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) had been detected in Valsartan bulk drug substances manufactured by Chinese manufacturers. Subsequently, a worldwide recall was issued of pharmaceutical products that use Valsartan bulk drug substances. Valsartan is used in the treatment of high blood pressure and congestive heart failure.

The FDA has announced analysis methods using gas chromatography mass spectrometry (GC-MS and GC-MS/MS) as detection methods for NDMA and NDEA, while the European Directorate for the Quality of Medicines (EDQM) has announced analysis methods using liquid chromatography mass spectrometry (LC-MS/MS) and GC/MS as reference information.

GCMS-QP2020 NX

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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.

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

Small Molecule Pharmaceuticals

Development (Formulation, Scale-up, Method development)

Manufacturing, QA/QC

Data Integrity

Crude drugs

Biopharmaceuticals

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.