JFE-TEC Enters the “Pharmaceutical Products Analysis Business”

Outline

JFE Techno-Research Corporation (JFE-TEC; President: Seishi Tsuyama, Head Office: Chiyoda-ku, Tokyo) provides clients with advanced analysis and evaluation services using state-of-the-art analytical equipment as “Your best partner for monodzukuri (Japanese-style manufacturing).” Based on increasing needs for safety assessments and efficacy assessments of pharmaceutical products, JFE-TEC announced that it will enter the pharmaceutical products analysis business on a full-scale basis. In line with this move, the Company established a new Advanced Pharmaceutical Products Analysis Center and began business operations in April, 2016 at two locations, one at the Kobe Medical Device Development Center (MEDDEC) of the Kobe Biomedical Innovation Cluster (KBIC) at Port Island, Kobe, and the other at the Company's own Chiba Division.

Pharmaceutical products are used to maintain or restore the health of patients. Various standard tests in connection with safety and efficacy assessments of pharmaceutical products have been established to prevent health hazards to persons who take those products. At the same time, improvement in the reliability of these assessment tests is also demanded. Reviews of test methods and implementation of quality control systems utilizing computerization systems are being carried out in response to this need.

On the other hand, with the globalization of the pharmaceutical products market, manufacturing and quality control of pharmaceutical products are now being unified under strict EU standards. In order to conform to these strict standards, a further growth of needs related to safety and efficacy assessments is foreseen.

In the field of low-molecular drugs, which account for the majority of pharmaceutical products in the Japanese domestic market, generic drugs are being promoted based on the government's policy of encouraging the use of generics, and increasing needs for high-reliability assessments of differences in efficacy and impurities with new drugs are also expected.

The “Guideline for Elemental Impurities: ICH Agreement Draft Guideline (PFSB/ELD Notification 0930 No. 4)” was issued on September 30, 2015, and states that adequate risk assessments are to be performed for object elemental impurities in pharmaceutical preparations based on the Guideline, applicable to new pharmaceutical products for which applications for approval are made on or after April 1, 2017. This requirement will heighten the necessity of analysis of trace elemental impurities.

To respond to these increased needs for assessment testing, JFE-TEC has introduced various leading-edge analytical equipment, including a nuclear magnetic resonance (NMR) system, and provides the following new technical services.

(1) Facilities environment conforming to GMP*1 and ISO 17025

A facilities environment with the most recent features has been created, including a quality control system conforming to GMP and quality control by a computerized system, etc. JFE-TEC is in the middle of preparations for acquisition of laboratory accreditation for the quantitative NMR (qNMR) method under the international standard ISO 17025 and for implementing a system that guarantees high reliability. As a result of these efforts, it is possible for makers of pharmaceutical products and synthesizers of drug substances and pharmaceutical intermediates to perform external testing organization assessments under the same quality control system as analysis by the own company. A smooth response to inspections based on GMP Guideline under PIC/S *2 can be expected.

(2) Structural analysis of impurities in pharmaceutical products (including drug substances and pharmaceutical intermediates)

Structural analyses of substances are performed by separating trace impurities in pharmaceutical products by liquid chromatography and measuring their precise mass spectra and NMR spectra. To improve the reliability of structural analyses, JFE-TEC has introduced state-of-the-art NMR system as a contract analysis organization.

(3) Highly reliable purity analysis of active ingredients, etc.

In order to use instrumental analysis in determination of active ingredients, highly reliable standard products are necessary in accurate quantitative analysis. Because JFE-TEC now provides analysis services for standard products by qNMR, highly reliable purity analysis is possible.

(4) Elemental impurity analysis of pharmaceutical products (including drug substances and pharmaceutical intermediates) conforming to ICH*3 Q3D

JFE-TEC provides high-accuracy content analyses of trace elements in pharmaceutical products by using sample pretreatment equipment and an ICP-mass spectrometer (ICP-MS) installed in a cleanroom. In comparative analyses with PDE values, *4 analysis at the <0.01 mg/kg is amply possible by high sensitivity ICP-MS analysis of samples liquefied by optimum advanced pretreatment with minimal contamination.

*1  Good Manufacturing Practice : Standard for production control and quality control of pharmaceuticals and quasi-drugs.

*2  The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme : Pharmaceutical inspection agreement and scheme for cooperation in inspection of pharmaceuticals.

*3  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use : ICH is the abbreviation of this EU-Japan-US conference on harmonization of standards for pharmaceutical products.

*4  Permitted Daily Exposure : Allowable exposure per day.

In the future, JFE-TEC will continue to respond to assessment and analysis needs in the evolving field of pharmaceutical products by providing new technical services.

Reference materials

View of the Kobe Medical Device Development Center (MEDDEC)
View of the Kobe Medical Device Development Center (MEDDEC)
  NMR system
NMR system
View of JFE-TEC's Chiba Office
View of JFE-TEC's Chiba Office
  ICP-MS in the JFE-TEC cleanroom
ICP-MS in the JFE-TEC cleanroom

 

Inquiry about Products and Services

Click here for inquiries regarding services:

  • Inquiry Form
  • Ordering Procedure