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Expert Lyophilization Cycle Development for Biopharmaceutical Excellence

What is Lyophilization?

Lyophilization, or freeze-drying, is an advanced preservation method that stabilizes sensitive pharmaceuticals by removing moisture at low temperatures and pressures. The process freezes the product and then sublimes ice directly to vapor, preserving the integrity and activity of active ingredients. This technique extends shelf life and facilitates easier storage and transport, making it essential for many pharmaceuticals and biopharmaceuticals.

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Benefits of Lyophilization Cycle Development

  • Maximized Product Stability: Extend shelf life and reduce degradation risks.
  • Preserved Potency: Maintain bioactivity for consistent therapeutic performance.
  • Logistical Efficiency: Simplify storage and distribution by reducing cold chain requirements.
  • Cost-Effective Manufacturing: Lower waste and associated costs from product instability.

 

Our Lyophilization Cycle Development Process

  • Formulation Development: Custom solutions for enhanced freeze-drying compatibility.
  • Process Development: Optimized cycle design for maximum efficiency and reproducibility.
  • Scale-Up Studies: Seamless transition from lab to GMP-compliant commercial manufacturing.
  • Validation & QA: Regulatory-aligned testing to meet cGMP and ICH guidelines.
  • Final Product Testing: Comprehensive analysis to ensure long-term product integrity.

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If you are interested in working together, send us an inquiry and we will get back to you as soon as we can!

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250 Cross Farm Lane, York, Pennsylvania, 17406 USA

Phone Number

(717) 377 3547

Email Address

info@biotechnique.com

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