Development of Lyophilization Cycle for Improving Stability of Complex Injectables

Abstract: In solution, many drug substances are susceptible during processing, storage and small changes in temperature and environment, thereby triggering many degradation pathways. Highly complex injectables, whether small or large molecule, undergo degradation pathways that may include hydrolytic, oxidative, and aggregation reactions, compromising both potency and safety. In addition, injectables are often distributed “cold-chained,” either refrigerated or maintained frozen from storage to patient. Some injectables may also exhibit susceptibility to freezing and/or thawing. Lyophilization overcomes poor stability by rendering labile drugs and proteins in a solid form more tolerant of long-term product storage. This webinar “Development of Lyophilization Cycle for Improving Stability of Complex Injectables” is designed as an introduction to a program, taking in account varying freezing rates of buffers, excipients, their chemical effect and the physical dynamics of controlled process values within the art / science nature of lyophilization cycle development. Highlights of this webinar include developing:

 

  • Lyophilizable formulation matrix
  • Lyophilization parameters by understanding thermal properties of the lyophilizable matrix
  • Lyophilization cycle for transfer, scale up and GMP manufacturing

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Originally Presented Live By:
Indu Javeri is the President of CuriRx and former CEO of Formatech, Head of Manufacturing and Development Abbott Biotech, Associate Director Cambridge NeuroScience.


Friends and Colleagues,

The government has classified the biopharma industry as essential during this trying time. As such, CuriRx is keeping our doors open for business.

We will continue to provide quality contract R&D services in a timely manner and do our part to contribute patient care. At CuriRx, the health and well-being of our employees, clients, and the general public are still our topmost concern and priority. Internally, we are encouraging all staff to adhere to calls for social distancing, asking that they work remotely when possible and maintain a measure of physical distance while working in the lab.

As this pandemic continues to challenge our communities, we have also implemented a number of additional safety measures around the office, including extra hand sanitizer dispensers, “deep cleaning” of all surfaces and doorknobs with heavy duty disinfectants, and encouraging video conferences even internally to discourage the gathering of too many people in one room at a time.

As always, we will continue to monitor the situation globally and adjust our behavior according to federal, state and public health guidelines.

Stay safe and healthy,

CuriRx, Inc.