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Pharmaceutical Lyophilization Services

OFD Bio|Pharma has been providing biotechnology and pharmaceutical companies with custom lyophilization (freeze-drying) solutions for over 20 years. Whether your product is pre-clinical, in development, in a clinical phase, or commercially available, we have a tailored solution for you. Our services include Bulk API Lyophilization, Cycle Development and Stability Testing.

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Lyophilization Applications

Demand for lyophilization services are increasing every year because of the practical solutions it offers the biotechnology & pharmaceutical industry. The process is reliable and can effectively help improve shelf life and stability for the following applications:

  • Bulk Lyophilized APIs
  • Antibody Therapeutics
  • Microbial Therapeutics
  • Gene/Cell Therapeutics
  • Protein Therapeutics
  • Medical Devices
  • Combination Products

Lyophilization/Freeze-drying Capabilities & Services

What is Bio|Pharma?

OFD Bio|Pharma is a stand-alone division of Oregon Freeze Dry, the largest diversified lyophilizer in North America: 4 Plants located on both the West and East Coasts, over 450 employees, 36 chambers, and an R&D division along with research and pilot dryers.

What We Offer

From R&D to clinical to commercial scale, we offer non-GLP (grams to liters), GLP (grams to liters) and cGMP (1kg to 1,000 kg per batch). Delivery systems can include Quick Dissolve and Sublingual Tablets, Cell Stabilization (biologics to platelets), Bulk APIs (oral, nasal, pulmonary applications), Bulk Wound Care Powders, Combination Products, Wound Care Patches and Oral Patches. No matter what type of drug product you have, we have the formulation and lyophilization cycle development knowledge to help you achieve the best results.

Innovation

We bring an innovative approach to designing and successfully commercializing new product concepts, our partnerships include startups and fortune 100 multinationals. Our R&D and Innovation Teams are ready to assist: utilizing rapid prototyping, and our research dryer and pilot plant, to find a scalable lyophilization processes and solutions to address your unique preservation challenge.

LyoLock Difference

Our Proprietary LyoLock process means we will partner with you to understand your goals, critical quality attributes and then develop a safe design space custom to your project. We then test and refine to achieve optimal yields, applying our unique manufacturing capabilities and broad spectrum of experience to ensure successful commercialization.

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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Other Solutions

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.