We satisfy broad needs ranging from GCTP-compliant manufacturing, quality assessment, storage to transport
We offer flexible support from test manufacturing for pharmaceutical affairs consultation to manufacturing for clinical trials
For many of cellular and tissue based products, long-term storage and long-distance transportation face challenges that are difficult to overcome. PharmaBio offers a solution of a domestic manufacturing base for clinical trials within Japan.
In our own manufacturing facilities, we stably produce investigational new drugs that satisfy the quality standards required by both clients and Japanese regulatory authorities, and implement strict quality controls through to storage and transport of the products. Furthermore, we address manufacture-related issues, such as development of necessary technologies, inspection and verification of manufacturing processes, and validation.
PharmaBio’s contract manufacturing facility is dedicated to cellular and tissue based products. As customers’ partner throughout long-term clinical trial projects, we analyze problems and risks associated with each manufacturing step in production to stably supply high-quality investigational new drugs, and strive continuously to improve our quality and safety.
- Selection of materials including reagents and culture media based on both accessibility and regulatory requirements
- Development of validation plans
- Technical Transfer
- SOP development and optimization
- Pilot production and validation of manufacturing processes
- Development of required manufacturing technology
Investigational new drug production
1. Collection of raw materials and transportation to the manufacturing facility
- Donor screening
- Infectious agent testing
2. Cell preparation and processing
- Change of manufacturing scale
- Investigation and improvement of manufacturing processes
3. Quality assessment and safety testing
- Cell characterization analysis
- Viable cell count, etc.
- Viral/microbial testing
4. Storage and transportation
- Sample cryopreservation
- Investigation of transportation methods
Please consult us if you are considering Japanese market entry. We provide expert advice and GMP facilities to meet your needs for development, manufacturing, quality control, cell banking, and more.