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Lyophilization Cycle Development

Whether your company hopes to improve current processes or explore what is possible, our team of engineering professionals and scientists are ready to safely develop Lyo-cycles for your pharma program in our state-of-the-art facilities. 

Our products can range from antibody conjugates, collagen complexes, pre- and pro-biotics, flow cytometry reagents. Comp bead calibration solutions, flow cytometry excipients, magnetic beads and pretty much any material that can be suspended in excipient and lyophilized. Let’s get your materials in a more stable form through lyophilization. We will help you develop the critical parameters that are necessary for the repeatable and reproducible end products required to meet your product goals.

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Working with OFD Biopharma

Start to finish

Our staff of engineers and scientists provide customized parameters, data collection, validation, and scalability reports essential to optimize any of the following:

  • Immunotherapy
  • Microbial Therapeutics
  • Cell/Gene Therapeutics
  • Bulk Lyophilized APIs
  • Medical Devices
  • Combination Products
  • Reagent kits
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OFD BioPharma’s proprietary LyoLock process ensures that product success criteria can be met via goal setting, formulation, rapid prototyping, and validation testing facilitated by our expert R&D and innovation team members.

Our Facilities

Located on our main campus in Albany, OR, Oregon 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.

Our Development and Clinical 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 BioPharma is on the cusp of introducing a patented new delivery platform for shelf-stable materials that will revolutionize the distribution and accessibility of pharmaceutical solutions. This platform will reliably lyophilize precise quantities ranging from 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.

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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.