HQ (high-quality) grade reagents
Transitioning from research to scaled-up GMP mRNA production can present challenges, such as maintaining optimal yields and integrity, managing batch-to-batch variability, and addressing complications in purification methods. While GMP-grade reagents can support consistency and facilitate a smoother transition during early development, many GMP features are unnecessary and the use of GMP-grade reagents may add significant costs.
Takara Bio's HQ-grade reagents are manufactured to a higher standard than research-grade reagents and meet many of the requirements for GMP grade. For a seamless transition to scaled-up manufacturing, HQ-grade reagents provide:
- High-quality, consistency, and reliability for process development
- High volumes for scaling up production
- Greater similarity to GMP-grade reagents than research-grade reagents
The descriptions and tables below detail the differences between these three categories of reagent grade.
Descriptions of each reagent grade
Research grade
Research-grade reagents are manufactured to meet the quality standards of general research reagents.
HQ grade
HQ-grade reagents are manufactured to many of the same quality standards as GMP-grade reagents but may not be manufactured in a GMP facility. HQ-grade reagents are a good choice for researchers who need high-quality reagents but do not need GMP-grade reagents, such as in nonclinical tests or process development.
GMP grade
GMP-grade reagents are manufactured and quality controlled in accordance with the GMP guidelines of PIC/S (Pharmaceutical Inspection Agreement and Pharmaceutical Inspection Joint Scheme). GMP-grade reagents may be suitable for manufacturing active pharmaceutical ingredients for clinical trials.
Quality features of each reagent grade
| Therapeutic development stage | ||||
| Research | Development | Manufacturing | ||
| Quality feature | Evaluation stage | Research grade | HQ grade | GMP grade |
| Exonuclease/Endonuclease free | Final formulation | |||
|
Purity testing
|
Final formulation | - | ||
| AOF: animal- and human-origin free | Final formulation | - | ||
| Raw materials | - | - | ||
| β-lactam free | Final formulation | - | ||
| Raw materials | - | - | ||
Compliance requirements of each reagent grade
| Therapeutic development stage | |||
| Research | Development | Manufacturing | |
| Evaluation stage | Research grade | HQ grade | GMP grade |
| Raw materials | ISO 9001:2015 | ISO 9001:2015 | PIC/S GMP |
| Manufacturing process | ISO 9001:2015 | ISO 9001:2015 | PIC/S GMP |
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