From RUO to GMP

Seamless Transition from Research to
Commercialization

We support you from early research materials to GMP-compliant manufacturing – ensuring a seamless transition without process disruption.

No need to change supplier when moving from RUO to GMP.

We ensure continuity, consistency, and scalability across all phases.

PAN-Biotech supports customers throughout the entire life cycle of biopharmaceutical, cell therapy, gene therapy, and advanced therapy development. Our portfolio is designed to meet the evolving requirements of research, preclinical development, clinical manufacturing, and commercial production, ensuring a seamless transition from early discovery to market-ready products.

During the research and development phase, scientists rely on high-quality catalog products for process development, assay optimization, proof-of-concept studies, and exploratory research. These research-use materials provide the flexibility and performance required to accelerate innovation and generate reliable data.

As projects advance into preclinical development, product requirements become more specific and process scalability becomes increasingly important. PAN-Biotech provides customized solutions tailored to individual process needs, helping customers establish robust workflows while preparing for future regulatory and manufacturing requirements. This stage enables the development of scalable processes and supports a smooth transition toward clinical applications.

For clinical development and commercial manufacturing, PAN-Biotech offers GMP-ready and GMP-compliant solutions designed to meet the highest standards of quality, consistency, traceability, and regulatory compliance. Our clinical-grade products support Phase I, Phase II, and Phase III clinical trials as well as commercial production, helping customers navigate complex development pathways while maintaining product quality and supply security.

By combining research products, customized solutions, and GMP-compliant manufacturing capabilities, PAN-Biotech serves as a long-term partner across the entire development journey. This integrated approach reduces development risk, simplifies technology transfer, and enables a more efficient path from scientific discovery to clinical and commercial success.

PAN-Biotech — RUO to GMP Flip Cards

A Comparison of Quality Standards

RUO(Research Use Only)

For research applications and early-stage development.

Quality Feature	Standard
Raw Materials	Cell Culture Grade
Water	HPW

Quality Feature	Standard
Production Facility	Cleanroom Class D to B
Single-Use Equipment	No
Environmental Monitoring	Scheduled
In-Process Control (IPC)	Standard

Quality Feature	Standard
Final Release (CoA)	Standard (e.g. pH, Osmolality, Sterility)
Analytical Methods	Qualified

Quality Feature	Standard
Production Record	Batch Record
Suitability (CoA)	RUO
Retain Samples	Yes
Change Control	No
Quality Agreement Available	No

GMP READY(Research Use Only)

For process development, scale-up and technology transfer.

Quality Feature	Standard
Raw Materials	EP / USP ¹⁾
Water	WFI quality water

Quality Feature	Standard
Production Facility	Cleanroom Class D to B
Single-Use Equipment	Yes
Environmental Monitoring	Scheduled
In-Process Control (IPC)	Standard

Quality Feature	Standard
Final Release (CoA)	Standard (e.g. pH, Osmolality, Sterility)
Analytical Methods	Qualified

Quality Feature	Standard
Production Record	Batch Record
Suitability (CoA)	RUO
Retain Samples	Yes
Change Control	No
Quality Agreement Available	No

GMP
GRADE

GMP

For clinical manufacturing and commercial production.

Quality Feature	Standard
Raw Materials	EP / USP ¹⁾
Water	WFI quality water

Quality Feature	Standard
Production Facility	GMP compliant clean room
Single-Use Equipment	Yes
Environmental Monitoring	Extensive ²⁾
In-Process Control (IPC)	Extensive ²⁾

Quality Feature	Standard
Final Release (CoA)	Extensive ²⁾ (e.g. Appearance, Mycoplasma, Endotoxin, Conductivity)
Analytical Methods	According to EP/USP

Quality Feature	Standard
Production Record	Master Batch Record
Suitability (CoA)	For further manufacturing
Retain Samples	Yes
Change Control	Yes
Quality Agreement Available	Yes

PAN-Biotech – Transitioning to GMP

The biggest challenge – transitioning to GMP

PAN-BIOTECH SOLUTION:

Same formulations

Same expertise

Seamless transfer

Ready to scale your process?

Contact our experts