Primo Biotechnology - CRO and CDMO

Core Advantages

Advanced Analytical Techniques: Delivering comprehensive analysis and rigorous quality control that consistently surpass stringent pharmacopoeia requirements.
Expertise and Experience：Years of experience radiopharmaceutical development—from isotope procurement to market authorization (MAA)—offering full-spectrum services from preclinical trials to commercial manufacturing.
GMP Certified Facilities：PIC/S GMP-compliant smart manufacturing and automated radiopharmaceutical facility supports multi-radionuclide production, delivering high-quality and high-efficiency yields.
Operational Flexibility：Flexibly tailoring radiopharmaceutical development solutions to meet global regulatory requirements, clinical needs, and packaging variations. We excel in both specialized small-batch production and large-scale commercial supply.

CRO Service

Radiopharmaceutical Development

(Pre)Clinical Trial Design

Research & Statistical Consultation

Data Analysis & Management

NDA Submission & Maintenance

Clinical Research Nurse Training

IND & IRB Submissions

Adverse Event Management & Reporting

Trial Monitoring & Quality Assurance

Trial Results Synthesis & Discussion

CDMO

Analysis & Development

Optimization of radiochemical labeling conditions and purification processes for various radionuclides, including F-18, Ga-68, and Lu-177.
Comprehensive stability studies and formulation development to ensure the safety, efficacy, and stability of radiopharmaceuticals for patient use.

Process Optimization

Refining and scaling laboratory preparation methods into stable, industrial-grade processes for large-scale production.

成品製劑

GMP Commercial Production
Aseptic Processing
Packaging & Labeling

Regulatory & Technical Support

CMC Documentation & Writing
IND / NDA / ANDA Submission Support
Tech Transfer
Global Quality Systems (QA/QC) Compliant with US FDA and EMA Guidelines

Success Stories

In collaboration with Antelope Surgical Solutions, we have launched the world’s first FDA-approved Phase I/II clinical trial for AS1986NS.The trial aims to evaluate the safety and efficacy of AS1986NS as a fluorescence-guided imaging agent during prostate cancer biopsy procedures. This innovation is expected to significantly enhance diagnostic precision and reduce the need for unnecessary surgical interventions.

Collaborating on the clinical trial design for a novel radiopharmaceutical as it enters its First-in-Human (FIH) Phase I trial.This study aims to effectively detect atherosclerosis through non-invasive molecular imaging, providing critical insights that will shape future therapeutic decision-making.

Collaborating on the development and manufacturing of novel Targeted Radionuclide Therapies for the diagnosis and treatment of solid tumors—partnering to achieve a new milestone in precision oncology.

CRO and CDMO