Introduction:
The article discusses effective strategies for endotoxin removal in therapeutic protein purification. It highlights the challenges posed by endotoxins in the purification process and their potential harmful effects. The article also mentions the importance of low endotoxin levels in downstream processes and presents proven purification workflows for reducing endotoxin levels in protein therapeutics.
- Endotoxins are pyrogenic impurities in therapeutic protein preparations that can cause septic shock, tissue injury, and death.
- Endotoxins are released from gram-negative bacteria during cell lysis and are thermally stable and insensitive to pH changes.
- Case studies have shown successful use of various resins for endotoxin removal.
- Strategies for overcoming purification challenges caused by endotoxins are discussed.
- Proven purification workflows are presented that significantly reduce endotoxin levels in protein therapeutics.
Conclusion:
Effective strategies for endotoxin removal are essential in therapeutic protein purification to ensure low endotoxin levels and overcome purification challenges. Various resins and purification workflows have been successful in reducing endotoxin levels and improving the safety and quality of protein therapeutics.