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The United States Pharmacopoeia (USP) issued a pharmacopoeial notice on May 29, 2020, stating that the synthetic alternative to natural limulus reagents—recombinant factor C (rFC) was introduced into USP-NF as a separate chapter, and the original plan for bacterial endotoxin testing standards was abandoned.
Proposals for revision of existing chapters.
Proposals for revision of existing chapters.
The United States Pharmacopoeia (USP) issued a pharmacopoeial notice on May 29, 2020, stating that the synthetic alternative to natural limulus reagents—recombinant factor C (rFC) was introduced into USP-NF as a separate chapter, and the original plan for bacterial endotoxin testing standards was abandoned.
Proposals for revision of existing chapters.
Proposals for revision of existing chapters.
For a long time, limulus reagent (blue blood rich in copper in limulus) has been used for the detection of endotoxin in sterile drugs.
In recent years, the rFC produced by the Swiss-based Lonza company can replace the limulus reagent.
But Lonza’s rival, another testing product giant, Charles River Laboratories, criticized this synthetic alternative for safety reasons.
It is estimated that the number of endotoxin tests performed every year is 70 million, and the size of the relevant market is estimated to be USD 1 billion per year by 2024.
In recent years, the rFC produced by the Swiss-based Lonza company can replace the limulus reagent.
But Lonza’s rival, another testing product giant, Charles River Laboratories, criticized this synthetic alternative for safety reasons.
It is estimated that the number of endotoxin tests performed every year is 70 million, and the size of the relevant market is estimated to be USD 1 billion per year by 2024.
For a long time, limulus reagent (blue blood rich in copper in limulus) has been used for the detection of endotoxin in sterile drugs.
In recent years, the rFC produced by the Swiss-based Lonza company can replace the limulus reagent.
But Lonza’s rival, another testing product giant, Charles River Laboratories, criticized this synthetic alternative for safety reasons.
It is estimated that the number of endotoxin tests performed every year is 70 million, and the size of the relevant market is estimated to be USD 1 billion per year by 2024.
In recent years, the rFC produced by the Swiss-based Lonza company can replace the limulus reagent.
But Lonza’s rival, another testing product giant, Charles River Laboratories, criticized this synthetic alternative for safety reasons.
It is estimated that the number of endotoxin tests performed every year is 70 million, and the size of the relevant market is estimated to be USD 1 billion per year by 2024.
As a synthetic reagent, rFC can replace American horseshoe crab reagent (LAL) and oriental horseshoe crab reagent (TAL) derived from limulus blood for endotoxin detection.
The main advantages of rFC reagents are improved consistency and sustainability.
Variation is a common feature in all animal-derived products.
The consistency of synthetic reagents can make the production and detection process easier to control, and because rFC can be produced without restrictions, it is more sustainable.
The main advantages of rFC reagents are improved consistency and sustainability.
Variation is a common feature in all animal-derived products.
The consistency of synthetic reagents can make the production and detection process easier to control, and because rFC can be produced without restrictions, it is more sustainable.
As a synthetic reagent, rFC can replace American horseshoe crab reagent (LAL) and oriental horseshoe crab reagent (TAL) derived from limulus blood for endotoxin detection.
The main advantages of rFC reagents are improved consistency and sustainability.
Variation is a common feature in all animal-derived products.
The consistency of synthetic reagents can make the production and detection process easier to control, and because rFC can be produced without restrictions, it is more sustainable.
The main advantages of rFC reagents are improved consistency and sustainability.
Variation is a common feature in all animal-derived products.
The consistency of synthetic reagents can make the production and detection process easier to control, and because rFC can be produced without restrictions, it is more sustainable.
In 2018, the FDA approved the first drug for endotoxin testing based on rFC reagents.
This opens the door to the widespread adoption of rFC detection methods.
In September 2019, the USP Microbiology Expert Committee proposed to add rFC to the existing chapter USP<85> on bacterial endotoxin testing standards.
However, USP stated in a statement on the 29th that based on the opinions of stakeholders and the establishment of a disclosure process in accordance with USP standards, the expert committee decided to cancel the proposal to amend the original endotoxin determination chapter, and instead adopt the new guidance for rFC reagents as USP- Proposed in a separate chapter of NF.
The proposed independent chapter will be solicited from the public in November this year.
This opens the door to the widespread adoption of rFC detection methods.
In September 2019, the USP Microbiology Expert Committee proposed to add rFC to the existing chapter USP<85> on bacterial endotoxin testing standards.
However, USP stated in a statement on the 29th that based on the opinions of stakeholders and the establishment of a disclosure process in accordance with USP standards, the expert committee decided to cancel the proposal to amend the original endotoxin determination chapter, and instead adopt the new guidance for rFC reagents as USP- Proposed in a separate chapter of NF.
The proposed independent chapter will be solicited from the public in November this year.
In 2018, the FDA approved the first drug for endotoxin testing based on rFC reagents.
This opens the door to the widespread adoption of rFC detection methods.
In September 2019, the USP Microbiology Expert Committee proposed to add rFC to the existing chapter USP<85> on bacterial endotoxin testing standards.
However, USP stated in a statement on the 29th that based on the opinions of stakeholders and the establishment of a disclosure process in accordance with USP standards, the expert committee decided to cancel the proposal to amend the original endotoxin determination chapter, and instead adopt the new guidance for rFC reagents as USP- Proposed in a separate chapter of NF.
The proposed independent chapter will be solicited from the public in November this year.
This opens the door to the widespread adoption of rFC detection methods.
In September 2019, the USP Microbiology Expert Committee proposed to add rFC to the existing chapter USP<85> on bacterial endotoxin testing standards.
However, USP stated in a statement on the 29th that based on the opinions of stakeholders and the establishment of a disclosure process in accordance with USP standards, the expert committee decided to cancel the proposal to amend the original endotoxin determination chapter, and instead adopt the new guidance for rFC reagents as USP- Proposed in a separate chapter of NF.
The proposed independent chapter will be solicited from the public in November this year.
This means that pharmaceutical companies seeking to use rFC must continue to perform additional verification work to ensure that their rFC testing methods are consistent with those using limulus reagents.
This decision left the pharmaceutical industry lacking motivation to end its dependence on animal-derived limulus reagents.
This decision left the pharmaceutical industry lacking motivation to end its dependence on animal-derived limulus reagents.
This means that pharmaceutical companies seeking to use rFC must continue to perform additional verification work to ensure that their rFC testing methods are consistent with those using limulus reagents.
This decision left the pharmaceutical industry lacking motivation to end its dependence on animal-derived limulus reagents.
This decision left the pharmaceutical industry lacking motivation to end its dependence on animal-derived limulus reagents.
USP stated on the 31st that experts concluded that there is almost no practical experience in the use of rFC to detect drugs, and that synthetic detection reagents cannot be compared with limulus reagents, which have been widely used for decades.
The USP stated in the statement that “in view of the importance of endotoxin testing in protecting patients, the committee finally decided that more real-world data is needed.
” It also added that this publication of independent chapters allows the US FDA to flexibly interact with pharmaceuticals.
Cooperate with vendors on rFC verification requirements.
USP also provided draft guidelines on rFC testing to developers of new coronavirus disease (COVID-19) vaccines and treatments, and stated that it will continue to work on the development of independent pharmacopoeial standards related to rFC.
The USP stated in the statement that “in view of the importance of endotoxin testing in protecting patients, the committee finally decided that more real-world data is needed.
” It also added that this publication of independent chapters allows the US FDA to flexibly interact with pharmaceuticals.
Cooperate with vendors on rFC verification requirements.
USP also provided draft guidelines on rFC testing to developers of new coronavirus disease (COVID-19) vaccines and treatments, and stated that it will continue to work on the development of independent pharmacopoeial standards related to rFC.
USP stated on the 31st that experts concluded that there is almost no practical experience in the use of rFC to detect drugs, and that synthetic detection reagents cannot be compared with limulus reagents, which have been widely used for decades.
The USP stated in the statement that “in view of the importance of endotoxin testing in protecting patients, the committee finally decided that more real-world data is needed.
” It also added that this publication of independent chapters allows the US FDA to flexibly interact with pharmaceuticals.
Cooperate with vendors on rFC verification requirements.
USP also provided draft guidelines on rFC testing to developers of new coronavirus disease (COVID-19) vaccines and treatments, and stated that it will continue to work on the development of independent pharmacopoeial standards related to rFC.
The USP stated in the statement that “in view of the importance of endotoxin testing in protecting patients, the committee finally decided that more real-world data is needed.
” It also added that this publication of independent chapters allows the US FDA to flexibly interact with pharmaceuticals.
Cooperate with vendors on rFC verification requirements.
USP also provided draft guidelines on rFC testing to developers of new coronavirus disease (COVID-19) vaccines and treatments, and stated that it will continue to work on the development of independent pharmacopoeial standards related to rFC.
Eli Lilly has converted endotoxin testing for drugs including migraine treatment Emgality to rFC testing.
Eli Lilly stated that rFC is safe, and the additional verification requirements have become an obstacle for more companies to adopt this method.
At the same time, environmentalists have also been promoting the use of rFC to reduce the demand for horseshoe crabs, some of which died after being released into the Atlantic after blood collection.
The National Audubon Society, Wildlife Defenders Association and other groups called for more use of rFC on June 1st.
They pointed out that this transition can save 100,000 horseshoe crabs each year on the east coast of the United States alone, and can help endangered migratory birds that depend on horseshoe crab eggs for survival.
Eli Lilly stated that rFC is safe, and the additional verification requirements have become an obstacle for more companies to adopt this method.
At the same time, environmentalists have also been promoting the use of rFC to reduce the demand for horseshoe crabs, some of which died after being released into the Atlantic after blood collection.
The National Audubon Society, Wildlife Defenders Association and other groups called for more use of rFC on June 1st.
They pointed out that this transition can save 100,000 horseshoe crabs each year on the east coast of the United States alone, and can help endangered migratory birds that depend on horseshoe crab eggs for survival.
Eli Lilly has converted endotoxin testing for drugs including migraine treatment Emgality to rFC testing.
Eli Lilly stated that rFC is safe, and the additional verification requirements have become an obstacle for more companies to adopt this method.
At the same time, environmentalists have also been promoting the use of rFC to reduce the demand for horseshoe crabs, some of which died after being released into the Atlantic after blood collection.
The National Audubon Society, Wildlife Defenders Association and other groups called for more use of rFC on June 1st.
They pointed out that this transition can save 100,000 horseshoe crabs each year on the east coast of the United States alone, and can help endangered migratory birds that depend on horseshoe crab eggs for survival.
Eli Lilly stated that rFC is safe, and the additional verification requirements have become an obstacle for more companies to adopt this method.
At the same time, environmentalists have also been promoting the use of rFC to reduce the demand for horseshoe crabs, some of which died after being released into the Atlantic after blood collection.
The National Audubon Society, Wildlife Defenders Association and other groups called for more use of rFC on June 1st.
They pointed out that this transition can save 100,000 horseshoe crabs each year on the east coast of the United States alone, and can help endangered migratory birds that depend on horseshoe crab eggs for survival.
Author: Lin know -Acorn
Author: Lin know -Acorn
