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Bulk Lyophilization Services

Leveraging 30 plus years of experience with bulk lyophilization equipment and techniques, OFD BioPharma staff are able to develop a cycle to optimize your formulation for small to large scale lyophilization. Processes can be amplified to dry up to 1000 Kg of wet material in our proprietary custom lyophilizers producing 10 Kg to 300 Kg of dry material. Our brand-new ISO 5 / BSL 2 compliant research and design facility allows us to develop drying cycles and manufacture bulk drug substances, medical devices, and biological products in aseptic, bio-safe conditions.

Working with OFD for Bulk Lyophilization

We can lyophilize Pharmaceutical Ingredients with the following applications:

  • Oral
  • Nasal
  • Pulmonary
  • Topical

Lyocycle

OFD BioPharma’s Proprietary LyoLock process ensures your project is properly onboarded and that product success criteria can be met via goal setting, formulation, rapid prototyping, and validation testing facilitated by our R&D and Innovation Team members. We are experts in optimizing products’ value through efficient and compliant lyophilization development.

Benefits include:

  • Individual component characterization
  • Recommendations for optimization of excipients for best outcomes
  • Understanding of crystalline formation during freezing process
  • Proper understanding of time-temperature-pressure manipulation
  • Increased efficacy and product stability

Our Facilities

Located on our main campus in Albany, OR, is a new low bioburden ISO 5 / BSL 2 facility where we can safely develop Lyo-cycles for your custom product or material. In addition to smaller scale programs in the new Research and Development facility, we have a variety of bulk lyophilization dryers in our facilities that can scale for pre-clinical, clinical, or commercial volumes.

The Research and Development facility features:

  • Millrock pilot scale dryer
  • Clinical dryer [1/10 scale]
  • Commercial dryer 
  • Aseptic clean rooms
  • World-class infrastructure to help develop and commercialize your product
  • State of the art lab for materials testing and validation

Our Commercial production facility features:

  • Pre-lyophilization steps, including but not limited to mixing and filtering
  • Lyophilization chambers
  • Separate cold rooms
  • In-process analytical and environmental laboratory

Our Technology

OFD Bio Pharma is on the cusp of introducing a proprietary new delivery system for materials that will revolutionize the lyophilization market. We can lyophilize small precise quantities 5ul to 250μl. 

This platform will provide:

  • Flexible dosage range
  • Maximized dose count per lot
  • Cost Effectiveness per dose
  • Varied delivery applications

Featured Case Study

Nutritional Supplement Probiotic Viability

A leader in the probiotic nutritional supplement space recently approached us and asked if we would be willing to participate in a shelf life viability comparison study using two of their probiotic strains.

Learn More
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Let’s Win Together

For over 50 years OFD has set the standard of excellence in Lyophilization. We’re ready to apply our experience and unique manufacturing capabilities to find a successful, scalable solution to address your unique preservation challenge.

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