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Thank you for your interest in Pii and our eBook on Lyophilization Trends in Pharma & Biopharma Drug Development

Find out what is driving the lyo market and how working with a CDMO will save time and money and help you comply with increasing regulatory requirements.

In this exclusive Lyophilization e-book from Pii, you will learn how to:

  • Achieve finished product lyophilization with limited API
  • Ensure agile scale up
  • Develop an Effective and Optimized Lyophilization Cycle
  • Navigate Regulatory Demands
  • Realize Quality Outcomes
  • Overcome Stability Challenges
  • Save Time and Costs
  • Test and Select the Best Closure
  • Determine Your Overall Lyophilization Needs
Pii Lyophilization eBook

What is Lyophilization?

Lyophilization is a drying process commonly employed for thermolabile materials where a solution of the labile active, along with excipients, is converted to a stable solid cake for storage, distribution, and dosing upon aqueous reconstitution. In the last 15 years, there has been significant growth in the approval of various lyophilized drugs. It is known that many biopharmaceuticals cannot be commercially viable without undergoing lyophilization, so there is a need to spend more on the research and development of the lyophilization process for further advancement and refinement. Now, lyophilization accounts for 24% of the overall fill/finish market. Contract Development and Manufacturing Organizations (CDMOs) offer lyophilization services at early-stage product and cycle development and can scale up to GMP. And CDMOs can help offset the setup costs and time associated with lyophilization. A CDMO that offers lyophilization support helps the drug sponsor achieve their goals of developing and manufacturing commercial products with the highest quality standards. For instance, the CDMO can facilitate the drug development and manufacturing process by offering aseptic fill finish and lyophilization, bulk lyophilization, and non-aseptic fill-finish and lyophilization.

The Importance of Container Testing and Selection

Container closure systems provide an integral barrier to protect stability and sterility of the drug product during the shelf-life against microorganisms, reactive gases, and moisture. This is why most regulators are moving quickly toward a mandatory 100% Closure Container Integrity Testing (CCIT) for all parenteral products, even though as of today this is required only for containers closed by fusion (glass or plastic ampoules) and samples of other containers should be checked for integrity according to appropriate procedures (to be defined and validated). It is widely accepted that CCIT will be extended to all containers and all pharmacopeias. 1 Choose and design the container and its closure system in such a way that they can guarantee the required stability and integrity not only after manufacturing, but for the whole shelf life of the product. It is essential to check and choose all the materials involved, their stability, and their mutual interactions over time and under expected environmental conditions. Interaction with the drug to be manufactured must also be considered and checked.

Regulating Lyophilization

There are stringent GMP guidelines for the manufacture of freeze dryers. Because lyophilization equipment stabilizes drug molecules used for improving human health or animal health, it is necessary to follow the guidelines from various regulatory bodies like the Food & Drug Administration (FDA) and European Regulatory bodies.

FDA Manufacturing Guidelines

  • GLP/GMP compliance means having a validated designing, manufacturing, and testing facility for pharmaceutical and biopharmaceutical products. These guidelines contain the validation of the lyophilization process and equipment. As per these guidelines, the lyophilization equipment requires Performance Qualification.
  • FDA governs all inspection guidelines for the lyophilization of drug products. The Lyophilization of Parenterals (7/93) is the guide for the lyophilization of parenterals. This document is reference material for investigators and other FDA personnel.
  • The Center for Biologics Evaluation and Research (CBER) of the FDA regulates freeze-dried biological products in its section pertaining to residual moisture, as published in Title 21 of the Code of Federal Regulations for Food and Drugs.

 

View our Video on Lyophilization Cycle Development