Cycle Optimization - Lyoinnovation

Cycle Optimization

The SP Hull LyoStar 4.0 designed and built to enhance speed to market of biopharmaceutical products and represents a significant advancement in freeze dryer engineering. Based on a full-scale production freeze dryer to support rapid-scale-up, LyoStar 4.0 is a pilot-scale lyophilizer offering superior shelf mapping, rapid shelf freezing, unmatched process accuracy and reliability.

It also 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. In addition, SP's new freeze dryer uses an eco-friendlier refrigerant gas, which reduces the carbon footprint involved in lyophilization.

Ideal for rapid lyophilization cycle development, optimization and scale-up, the LyoStar 4.0 incorporates the very latest innovations in freeze-drying technology to protect valuable product by ensuring precise process control and robust reliability. To enable this, LyoStar 4.0 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;
- A 3D modelling package for computational fluid dynamics and process monitoring;
- Tempris® Wireless Sensors for real-time product temperature measurement.

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Faster Freeze-Drying

Lower R&D Cost

Improved Cake Quality and Appearance

Reduced Reconstitution Times

CASE 1

CASE 2

CASE 3

CASE 1
Pantoprazole sodium for injection: inconsistent with the original drug

Problem description：Moisture content is not up to standard, poor cake appearance
Optimization solution：ControLyo® Nucleation Technology

Optimization results：
1) The freeze-drying time is reduced from 32 hours to 23 hours, which is 28% shorter
2) The quality of the cake is greatly improved, very uniform, consistent with the original drug
3) The cake appearance and looseness are very good, consistent with the original research
4) The lyophilized sample dissolves quickly and has better resolubility.
5) The moisture is dried more thoroughly, in line with the requirements of the original drug

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CASE 2
A small molecule drug，long reconstitution times

Problem description：long reconstitution times
Optimization solution：ControLyo® Nucleation Technology and AutoMTM/SMART™ Freeze Dryer Technology

Optimization results：
1) The freeze-drying time is reduced from 32 hours to 20 hours, which is 37% shorter
2) The cake appearance was flocculent
3) The reconstitution times has been accelerated from more than 30s to less than 10s, which has met the declaration requirements
4) Cake shape is not complete, some samples were pulled out into the bottle stopper or sample chamber
5) Optimization suggestion: It is suggested that the sample size of 2 times is relatively good

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CASE 3
Double-antibody, Appearance defects

Problem description：Appearance defects
Optimization solution： AutoMTM/SMART™ Freeze Dryer Technology

Optimization results：
1) The freeze-drying time is reduced from 58 hours to 50 hours, which is 16% shorter
2) Most of the cakes are intact in shape
3) Some of the cakes in the middle micro collapsed
4) Optimization suggestion: It is suggested that the sample size of 1/2 times is relatively good

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