Cycle Development / Technology Transfer / Scale-Up

Cycle Tevelopment / Technology Transfer / Scale-Up

“Pharmaceutical technology transfer consists of planned and controls actions that are based on well-defined acceptance criteria to convey a manufacturing process, analytical method, packaging component, or any other step or process along the pharmaceutical drug lifecycle from an originator site, known as a sending unit (SU), to a new site, the receiving unit (RU).”
——PDA Technical Report No. 65: Technical Transfer

“The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.”
——ICH Q10 Pharmaceutical Quality System

“Quality by Design: A systematic approach to development that begins with predefined objective and emphasizes product and process understanding and process control, based on sound science and quality risk management.”
——ICH Q8 (R2) 2009

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Freeze-Drying Process Development

Lyo innovation follows the principle of QBD. Using process analysis technology (PAT), develop freeze-drying process, monitor key process parameters, and monitor their impact on product quality. Create an optimal design space to provide reliable support for process transfer and scale-up.

It includes a cutting-edge suite of Process Analytical Technology (PAT) tools augmenting SP's Line of Sight™ suite of technologies which overcomes critical lyophilization challenges during development, scale‑up and manufacturing of a biologic.

Ideal for rapid lyophilization cycle development, optimization and scale-up, LyoStar 4.0 incorporates the very latest innovations in freeze-drying technology to protect valuable product by ensuring precise process control and robust reliability. LyoConstellation™ scale freeze-dryers meet both process development and commercial production and aseptic operation requirements.

To enable this, LOS has a number of sophisticated, upgradeable PAT tools including:
- LyoFlux® TDLAS Sensors for vapor mass flow measurement;
- AutoMTM/SMART™ Freeze Dryer Technology, a primary drying cycle optimization tool;
- ControLyo® Nucleation Technology giving pinpoint control of freezing point;
- Tempris® Wireless Sensors for real-time product temperature measurement.

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