Ph. Eur. Revises Bacterial Endotoxin Chapter - Adds Recombinant Factor C as an Alternative Method

The European Directorate for the Quality of Medicines & HealthCare  (EDQM) has recently proposed a significant revision to European Pharmacopoeia Chapter 5.1.10, Guidelines for Using the Test for Bacterial Endotoxins.

The proposed revision includes the use of alternative reagents to the Limulus amoebocyte lysate (LAL), such as recombinant factor C: this practice avoids the use of endangered animal species and can be considered in the context of the use of an alternative method as described in the General Notices.

The proposed revision includes the following additions:

• Replacement of the rabbit pyrogen test required in a pharmacopoeial monograph by an amoebocyte lysate test, or by other methods such as the monocyte-activation test or a test using recombinant factor C as a replacement for the amoebocyte lysate, constitutes the use of an alternative method of analysis and hence requires demonstration that the method is appropriate for the given substance or product and gives a result consistent with that obtained with the prescribed method as described in the General Notices.
• Replacement of a rabbit pyrogen test or a bacterial endotoxin test prescribed in a monograph by a test using recombinant factor C or any other reagent as a replacement of the amoebocyte lysate is to be regarded as the use of an alternative method in the replacement of a pharmacopoeial test, as described in the General Notices.
• The test and assays described are the official methods upon which the standards of the Pharmacopoeia are based. With the agreement of the competent authority, alternative methods of analysis may be used for control purposes, provided that the methods used enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used. In the event of doubt or dispute, the methods of analysis of the Pharmacopoeia are alone authoritative.

The deadline to submit comments on the proposed revision is December 31, 2014.

The revision is found in Pharmeuropa, Issue 26.4. The online version can be accessed at http://pharmeuropa.edqm.eu/home/. Access to the online version requires registration, but this is a free service.

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Presenting Our Latest Rapid Methods Webinar Series

In response to the positive feedback received from last year's rapid microbiological methods webinar series, we have developed five new seminars that will be presented in October and November.  Visit our Calendar of Events Page for agendas and registration information. Sessions will include an introductory-level webinar on applications, scientific principles and implementation, as well as advanced online courses on validation strategies, RMM technologies, global regulatory expectations and how to develop a business case and return on investment model.

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ASM Statement on National Strategy to Combat Antibiotic Resistant Bacteria

The American Society for Microbiology (ASM) congratulates the Administration for its September 18 announced White House National Strategy for Combating Antibiotic Resistant Bacteria (CARB).   The strategy outlines bold steps to slow the public health threat of antibiotic resistant bacteria, including efforts to stimulate innovative research.   Importantly, the Strategy will establish a new Task Force for Combatting Antibiotic Resistant Bacteria which is directed to submit an action plan to the President by February 2015. This elevated attention at the highest level of government is needed because in the United States alone, antibiotic resistant bacteria cause 2 million infections a year and 23,000 deaths.

Innovative research is needed to discover new, effective antibiotics and to ensure existing antibiotics are properly targeted. Research will lead to innovative diagnostics to improve detection and tracking of pathogens, new vaccines targeted to drug resistant organisms and new antibiotics in partnership with private industry. Cutting edge genetic sequencing technologies used at point of care can enhance surveillance of antimicrobial resistance, enabling rapid tracking of genetic signatures and ensure rapid, accurate diagnosis and appropriate use of antibiotics saving lives and reducing resistance resulting from inappropriate treatment.  Because an estimated half of antibiotic prescriptions are inappropriate, encouraging the development of rapid, point of care tests is critical to identifying and tailoring treatment of resistant bacteria and minimizing the use of broad spectrum antibiotics.  

The National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) will play leading roles in the national response. The collaborative efforts of the these agencies will be extremely important to advance development and use of rapid diagnostic tests for identifying drug resistant infections. Enhanced regulatory processes and reduction in approval cycle time will be key. Reimbursement of new diagnostic tests will also be a major incentive for development of new diagnostics by the private sector. The recommended expansion of DNA sequencing capacity and collection of microbial genetic sequences in a centralized National Database of Resistant Pathogens will allow comparison of outbreak stains with the database collection, improving their control.

The emphasis on tracking resistance in humans, animals and food and promoting antibiotic stewardship across the food chain is vitally important, as well as minimizing antibiotic use for non-health purposes. The Executive Order calls for work internationally, recognizing that efforts must be global to reduce the burden of antimicrobial resistance and its spread.

The National Strategy articulates national goals, priorities and specific objectives that provide an overarching framework for federal investments to combat antimicrobial disease. It will be extremely important that new and adequate funding is provided to accomplish this comprehensive agenda. The ASM appreciates the new initiatives and is committed to working with federal agencies and Congress as this ambitious agenda to address the threat of antimicrobial resistance gets underway.

Source: American Society for Microbiology.

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FDA Food Safety Challenge to Spur New Technologies for Fighting Foodborne Illness

The U.S. Food and Drug Administration is asking for potential breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.

The 2014 FDA Food Safety Challenge was developed under the America COMPETES Reauthorization Act of 2010, which grants all federal agencies broad authority to conduct prize competitions to spur innovation, solve tough problems, and advance their core missions. This challenge offers a total prize pool of $500,000.

Concepts must be able specifically to address the detection of Salmonella in minimally processed fresh produce, but the ability of a solution to address testing for other microbial pathogens and in other foods is encouraged.

Food safety experts such as scientists, academics, entrepreneurs, and innovators, as well as those new to the field, are encouraged to participate in the challenge, which launches September 23. A panel of food safety and pathogen detection experts from the FDA, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture will judge the submissions, determine finalists, and select a winner or winners.

“We are thrilled to announce the FDA’s first incentive prize competition under the America COMPETES Act,” said Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. “This is an exciting opportunity for the federal government to collaborate with outside experts to bring forth breakthrough ideas and technologies that can help ensure quicker detection of problems in our food supply and help prevent foodborne illnesses.”

While the American food supply is among the safest in the world, an estimated 1 in 6 Americans is sickened by foodborne illness annually, resulting in about 3,000 deaths, according to the CDC.  Salmonella is the leading cause of deaths and of hospitalizations related to foodborne illness, estimated to cause 380 deaths and 19,000 hospitalizations in the United States each year.

Those interested in participating should submit concepts to the FDA by Nov. 9, 2014. Up to five submitters will be selected to advance as finalists. Finalists will be awarded $20,000 and will have the opportunity to be coached by FDA subject matter experts who will help them mature their ideas before they present their refined concepts to the judges.

For a complete list of challenge rules and to submit a concept, visit http://www.foodsafetychallenge.com.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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