Bio-Tech

Bridge the gap between potential and application and deliver radiotherapies to market

A flexible approach to development and production.

Our flexible approach allows us to adapt to diverse client needs across the entire spectrum of drug development and manufacturing.

Outcome

Establishing radiolabeling procedures, attaching radioisotopes to antibodies, peptides, and other small molecules. Creating and validating analytical methods. Ensuring processes and analytical methods meet regulatory requirements. Evaluating drug stability in different conditions. Defining product shelf-life and storage needs.

Outcome

Adherence to laboratory best practices and regulations. Quality control throughout development. Guidance through regulatory processes. Assistance in drafting CMC regulatory submissions (e.g., IND).

Outcome

Scaling up from lab to pilot production. Managing technology transfers. Securing consistent raw material supplies, including radioisotopes.

Outcome

Administrative setup and project design for manufacturing for clinical trials. Establish protocols for and execution of process validation. Scaling up processes and confirming methodology. Perform tests to ensure product stability. Compile comprehensive reports for regulatory submission. Secure consistent raw material supplies, including radioisotope. Management of technology transfer in different clinical and commercial phases.

Ensure reliable, and rapid manufacturing and delivery

No matter where you are on your targeted radiotherapy journey, you’ll receive optimal services that rapidly advance your program—we’re your dedicated partner every step of the way.

2K Sq Ft

Dedicated R&D operations in MN

7.5K Sq Ft

Dedicated Manufacturing Space in MN

Client-centric CDMO that offers a unique model that enables rapid delivery with the highest quality standards

Without the proper planning or resources, you may not be able to reach patients in time—which ultimately wastes valuable doses. . With these unique demands in mind, we’re building our development and manufacturing facilities in proximity to prominent destination medical centers and key distribution hubs to ensure your therapies reach those who need them most.

Flexibility

Flexibility to meet your project needs and the ability to scale capacity to meet the demand.

CMC

Built to standards 21 CFR Part 210/211 cGMP, ISO 13408-6, 10 CFR 20, and EU GMP Annex 1 (Expansion Sites)

LABS

From development and formulation to stability program management, our team with help you innovate with confidence.

Isotope Supply

With the capacity to work with any and all isotopes, regardless of their complexity, our expert team can consult on target material optimization, manage seamless radiopharmaceutical technology transfers, and more.

Clinical Trial Manufacturing

From administrative setup & project design to process validation protocols, methodology confirmation, and product stability, our experts will compile comprehensive reports for regulatory submission.

Scale-Up Management

No matter where you are on your targeted radiotherapy journey, you’ll receive optimal services that rapidly advance your programs. From managing tech transfers and scaling from lab to pilot production, we’re your dedicated partner every step of the way.

Flexible end-to-end CDMO services you can trust to accelerate your path to market

LABS

Regardless of your isotope, we have the capacity and expertise to support the advancement of your radiotherapy or theranostic.

Quality & Regulatory

Compliance from day one: our quality assurance helps you avoid costly setbacks and maintain seamless radiopharmaceutical production.

Manufacturing

Speed and scale: our state-of-the-art facilities provide the specialized infrastructure needed to support radiopharmaceutical manufacturing at any stage.

Supply Chain

Don’t let supply chain issues stop you: provide the radiopharmaceuticals patients need by leveraging our specialized logistics.

Quality Assurance and Regulatory Compliance

All our facilities are built to exceed compliance and our proactive design will help you meet radiopharmaceutical regulatory, safety, and operational requirements today and into the future.

cGMP environment

Facilities built for operating under 21 CFR Part 211 with PA/AZ expansion sites also aligned to EU Annex 1. ISO 13408-6 Aseptic processing of health care products.

Radiation safety program

Manufacturing and R&D facilities independently licensed for radioactive materials and transportation approvals for shipping hazardous materials. State of the Art Carbon Filtration System Compliant to USNRC Regulatory Guide 1.52 for residence time and volumetric airflow.

Electronic QMS

Corporate Quality Management System established and aligned to 21 CFR Part 211 and ICH Q10.

Biotech FAQs

Radiopharmaceutical Manufacturing Challenges

Starting capacity at our Rochester, MN location is 10K product vials/year with the ability to scale manufacturing over time to ~40-50K product vials/year.

Our PA site will have an annual capacity of ~450K product vials/year. The expansion site will have two small scale lines with two isolators and multiple fully automated lines, with space to expand to meet the market demand.