Biointronの製造基準

Contract research organizations (CROs) play a pivotal role in supporting the life science industry with various research services, including for pharmaceutical, biotechnology, and medical companies, as well as research institutes. Biointron is a leading high-throughput recombinant antibody/protein expression provider, and our customized antibody services are fully tailored to meet the specific needs of our clients.

Biointron follows stringent production’s standards and quality control systems for all processes. We are certified to the ISO 9001:2015 standard, which involves:

• The ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.

• Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

Our key production standards:

1. Quality Assurance Procedures: Our procedures include testing in a laboratory that meets international standards for quality and competency.  

2. Standard Operating Procedures (SOPs): Each procedure has step-by-step instructions on how to perform the test, including sample preparation, equipment calibration, and data analysis, ensuring consistency and reliability in results. We follow precise methods for equipment operation, material handling, formulation, packaging, labeling, and storage. 

3. Defined Administrative Requirements: Biointron ensures mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs. This includes specifying corrective actions, documentation, and the persons responsible if issues are identified.

4. Facilities and Equipment: Biointron maintains state-of-the-art facilities and equipment, with facilities designed to minimize risk of contamination. Equipment qualification, calibration, and maintenance processes are essential to ensure consistency.

5. Qualified Personnel: All employees are highly skilled professionals who are trained on specific production’s procedures. Regular training and development programs help to ensure that personnel remain updated with the latest industry practices, and personnel are required to demonstrate proficiency before conducting tests independently.

These standards are highly important as they directly influence the quality, safety, and efficacy of all products, and ensure excellence in our service.