Cytotoxic Challenges

Why is it so difficult to find a CDMO who can perform on cytotoxic drug manufacturing projects and still provide formulation expertise?

It is expensive to build dedicated cytotoxic and non-cytotoxic facilities. Some CDMOs have “containment strategies,” but separate buildings, equipment and air-handling systems are necessary to ensure maximum safety.

Those that do invest in dedicated facilities are either very large (and can be unresponsive), operate offshore to save money (and can subject you to customs and transportation delays) or at worst—both!

The few remaining options can manufacture cytotoxic drugs to specification, but most lack the decades of particle engineering and drug formulation that you will find here at CritiTech.

Cytotoxic Expertise

  • Hundreds of worldwide patents related to cytotoxic drug development
  • Three partner cytotoxic drugs in nine clinical trials
  • POC to GMP scale experience
  • 100% of staff experienced with cytotoxic drug manufacturing
  • Formulation, method development, manufacturing, analytical and fill-finish

Dedicated Cytotoxic Facilities

  • Separate buildings, equipment and air-handling systems for cytotoxic and non-cytotoxic drug manufacturing
  • Comprehensive hazardous waste disposal and cleaning verification programs
  • Quality by Design with extensive training, procedures, change controls and CAPA
  • Spray Drying and our proprietary Purcision™ available in both cytotoxic and non-cytotoxic

Full Lifecycle Spray Drying

CritiTech’s POC and GMP cytotoxic spray dryers utilize nitrogen systems advantageous for oxygen-sensitive and hygroscopic compounds. We can create dispersions and powders and work with both potent and non-potent compounds.

Learn more about our Spray Drying

Comprehensive Analytical Services

Our full-service GMP analytical laboratory includes onsite scanning electron microscope, next-generation impactor and a full suite of testing tools. We are experts in analytical method development and validation.

See all our Analytical Services

Unlike many CDMOs, we did not add cytotoxic drug manufacturing capabilities during expansion—we started our first work in cytotoxic drug development. As we grew, we decided to expand facilities into dedicated non-cytotoxic as well. Not only do we have dedicated facilities conveniently right in the center of the country, we are formulation experts who will partner with you to optimize your cytotoxic drugs. We are responsive, transparent, committed to our client’s timelines, and are proudly made in the U.S.A.

CritiTech is now booking cytotoxic spray drying projects for Q3 and Q4 2022.