(e-Book) 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
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.
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