Manufacturing & Process Development

State-of-the-art facilities are important, but the knowledgeable team is what sets our manufacturing apart.

Pharmaceutical Manufacturing & Drug Process Development

As your manufacturing partner, we can support you throughout the drug development lifecycle

Pharmaceutical drug development is a complex process, and one with little margin for error. If you want to bring a new drug to market successfully, it’s important to have a pharmaceutical manufacturing company working by your side you can trust. Outsourcing drug development to an experienced partner gives you peace of mind that comes from knowing the finished product will be as effective as it can be. Fortunately, CritiTech Particle Engineering Solutions is the drug manufacturing company you can rely on to bring the most advanced pharmaceutical process development techniques to your operations.

CritiTech manufactures non-GMP and cGMP materials using our Spray Drying Technology and Supercritical Precipitation Technology. We have separate facilities for cytotoxic and non-cytotoxic drug production and numerous manufacturing suites. Our manufacturing services are supported and reviewed by an experienced, in-house team of quality experts. The advanced technologies we employ in our drug process development services enhance the effectiveness of the finished product by increasing its potential for bioavailability in the body. At the same time, they serve to improve the efficiency and scalability of our processes to help meet your needs. Our capabilities also contribute to a more effective quality assurance program, as well.

Customized Pharmaceutical Development

When we serve as your drug process development and manufacturing partner, you will receive flexible, customized options that align with your needs. Our spray drying and supercritical precipitation techniques optimize the efficacy of pharmaceuticals by creating specific particle shapes and sizes that maximize their ability to be absorbed into the bloodstream. This means as much of your active ingredients will be used by the body, improving the outcomes for patients.

We’re also committed to helping you meet your compliance needs. We follow all cGMP standards in our facility, so you can be confident that your products will be manufactured with the utmost care and adherence to regulatory requirements.

Manufacturing Services

  • Manufacturing Process Development & Validation
  • Manufacturing Scale-Up
  • Batch Record Creation
  • Cleaning Method Development & Validation
  • CMC Support Services
  • Milligrams to Hundreds of Kilograms Production Scale

If your company has existing Spray Drying processing parameters from a Buchi or Mobile Minor, they are compatible with and can easily be transferred to CritiTech for production at our facilities.

Types of Material

  • Cytotoxic Compounds
  • Non-Cytotoxic Compounds
  • Potent Compounds Down to OEL >0.03 µg/m3
  • DEA Schedule II-V Compounds

Why Choose CritiTech?

When you choose to work with us to develop your next pharma product, you’ll gain much more than our advanced techniques. We also bring a customer-centric approach that ensures your needs will be met, as well as rigorous quality assurance processes. The expertise, innovation and experience we can add to your operations make us the ideal partner for all your drug development needs. To learn more about how we can help you, reach out to schedule a consultation or request a quote.