Latest news with #GoodLaboratoryPractice
Business Wire
07-08-2025
- Business
- Business Wire
ViruSure launches pioneering first-in-class viral contamination test for biopharmaceuticals using Oxford Nanopore technology
OXFORD, England & VIENNA, Austria--(BUSINESS WIRE)--ViruSure, a global leader in pathogen safety testing for biopharmaceuticals, and Oxford Nanopore Technologies ('Oxford Nanopore') (LSE: ONT), the company behind a new generation of molecular sensing technology based on nanopores, today announce the launch of the industry's first Good Laboratory Practice (GLP) validated adventitious viral agent (AVA) detection test using nanopore-based sequencing technology. The ViruSure test has been developed and evaluated under rigorous conditions and is powered by Oxford Nanopore's advanced molecular sensing platform. It will be used for the detection of viral contamination within the manufacturing process, providing biopharmaceutical teams with richer viral detection insights and faster time-to-result, accessibly and affordably. A rapid and sensitive test, it can detect AVAs regardless of virus type, to improve confidence in biomanufacturing safety. Viral contamination remains one of the most significant threats to biopharmaceutical manufacturing, causing production delays and potential biologic, vaccine and cell and gene therapy product shortages. Traditional viral detection methods can take months to provide the full panel of results, with each individual test often taking more than 14 days, and contaminants still going undetected or reported as false positives. This innovation addresses a critical need to streamline AVA detection within biomanufacturing, a rapidly growing market currently valued at $20 billion, of which at least $4 billion is related to AVA testing. Global regulatory authorities have also recognised the urgent industry demand for faster and more reliable solutions and actively encouraged the adoption of advanced sequencing-based testing methods. i Dr Andy Bailey, CEO of ViruSure, commented: 'The development of this cutting-edge test for adventitious agents marks a major advancement in the industry's ability to detect a wide range of contaminants with exceptional sensitivity. Offering significantly improved specificity compared to traditional short-read next-generation sequencing methods, this innovation sets a new benchmark in virus detection. Powered by Oxford Nanopore technology, the test produces datasets with minimal background noise, greatly simplifying the identification of potential viral signals. This crucial feature supports biopharmaceutical manufacturers in achieving faster product evaluation and release, enhancing both safety and efficiency.' Gordon Sanghera, CEO Oxford Nanopore, commented: 'Contamination during the biomanufacturing process can pose considerable risks to patient safety, as well as production delays and drug shortages, which is not wanted by biopharmaceutical companies – nor the patients and health systems they serve. With the introduction of this first-in-class test, ViruSure is directly addressing the industry's critical demand for rapid, information-rich, and cost-effective viral detection methods, and we're proud to have played a key role in its development.' ViruSure and Oxford Nanopore are also working together to introduce a Good Manufacturing Process (GMP)-validated solution, which they expect will follow shortly. About ViruSure ViruSure, an Asahi Kasei Life Science company, is a leading global Contract Research Organization specializing in virus and prion biosafety testing for the biopharmaceutical and life science industries, with more than 20 years of experience. Located in Vienna, Austria, ViruSure partners with industry to support their quality control testing needs and ensure the safety and purity of biopharmaceuticals, cell & gene therapies, and vaccines. ViruSure is an integral part of the Biosafety Testing Services Unit of Asahi Kasei Life Sciences. To learn more about ViruSure, visit About Oxford Nanopore Technologies Oxford Nanopore Technologies' goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used in more than 125 countries to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. Oxford Nanopore Technologies products are intended for molecular biology applications and are not intended for diagnostic purposes. For more, visit:
Barnama
25-06-2025
- Business
- Barnama
Fortrea, Emery Pharma Team Up On Rifampin Safety Testing For Clinical Trials
BUSINESS KUALA LUMPUR, June 25 (Bernama) -- Fortrea, a global contract research organisation (CRO), has announced a strategic collaboration with Emery Pharma to provide rapid impurity testing of rifampin used in drug-drug interaction (DDI) studies. In a statement, Fortrea said the partnership will enable testing for 1-methyl-4-nitrosopiperazine (MNP), a nitrosamine impurity, ensuring levels remain below the acceptable intake limit set by the United States Food and Drug Administration (FDA). Fortrea Chief Medical Officer and President of Clinical Pharmacology Services, Dr Oren Cohen said the partnership would help accelerate early-phase clinical trials by providing certified rifampin for use in DDI studies and enhance data quality. 'This collaboration reflects our shared commitment to smarter study design and greater participant safety,' he said. Meanwhile, Emery Pharma Chief Executive Officer, Dr Ron Najafi said the collaboration would contribute to safer and more efficient drug development, adding that the company specialises in solving complex analytical challenges in compliance with regulatory standards. Fortrea selected Emery Pharma based on its expertise in analytical and bioanalytical testing under current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) standards. The new testing service is now available to Fortrea customers involved in clinical pharmacology trials, with study designs tailored to FDA requirements. Rifampin, a widely used antibiotic and a preferred agent in DDI studies due to its safety and tolerability, had previously come under scrutiny after the FDA found that MNP levels in tested batches exceeded acceptable limits. However, the agency revised its guidance in 2023, allowing the continued use of rifampin under updated thresholds.
Barnama
25-06-2025
- Business
- Barnama
Fortrea & Emery Pharma Announce Strategic Collaboration To Deliver FDA Compliant Drug-drug-interaction Studies Using Rifampin
DURHAM, N.C., June 25 (Bernama) -- Fortrea (Nasdaq: FTRE) (the 'Company'), a leading global contract research organization (CRO), today announced a strategic collaboration with Emery Pharma, a leading analytical and bioanalytical CRO providing testing services under current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP), to provide rapid lot-by-lot, 1-methyl-4-nitrosopiperazine (MNP) testing of rifampin, the preferred drug for drug-drug interaction (DDI) studies, to certify impurities are below the Acceptable Intake (AI) Limit set by U.S. Food and Drug Administration (FDA) guidelines. Fortrea has selected Emery Pharma due to its strong capabilities in analytical and bioanalytical testing in support of Fortrea's global clinical programs. Emery Pharma's expertise in this area supports Fortrea's ability to offer rifampin as an agent for inducing the CYP3A4 isoenzyme in DDI studies. The collaboration announced today allows sponsors to conduct DDI assessments using rifampin, which is frequently named as the preferred agent in these studies, due to its safety and tolerability profile.
The Print
18-06-2025
- The Print
Telangana cops book Palamur Biosciences on animal cruelty charge after PETA ‘house of horrors' exposé
On 10 June, in a post on X, PETA India revealed large-scale animal abuse at the Telangana-based Palamur Biosciences Pvt Ltd, one of India's largest government-registered contract laboratories. The information provided by whistleblowers alleged that the facility was killing dogs and other animals without reason and with extreme cruelty, overcrowding them, and subjecting them to social isolation, among other things. PETA India, while asserting that such instances were not isolated but reflect a 'recurring pattern' in the global animal experimentation industry, called on the government to shut down the facility, which it dubbed a 'house of horrors,' and end animal testing in India. New Delhi: Police in Telangana's Mahabubnagar Tuesday booked Palamur Biosciences Pvt Ltd, a preclinical contract research organisation, on a complaint filed by People for the Ethical Treatment of Animals (PETA) India which last week cited revelations by a whistleblower to allege a pattern of animal cruelty at the firm's laboratory. The whistleblowers stepped forward to share video footage, images and testimonies after PETA India filed official complaints with authorities about the likely unauthorised testing on rhesus macaques at the same lab in October 2024, the report said. The lab claims it is 'one of the largest preclinical service providers' and tests drugs, pesticides, and medical devices on animals. It also runs a beagle breeding facility, where, according to the report, 1,500 beagles were being kept in a space for about 800. Dr Anjana Aggarwal, PETA scientist and research policy adviser, told ThePrint, 'This is not an isolated incident but rather business as usual, where systemic cruelty runs rampant.' 'Past investigations by regulatory bodies have revealed similar abuse and neglect of animals at other Indian labs, and PETA entities around the world have documented this as a recurring pattern in the global animal experimentation industry,' Dr Aggarwal added. In its report, PETA India had said it submitted a complaint with CCSEA, statutory body under the Prevention of Cruelty to Animals Act, 1960, as well as the CDSCO, the industry regulator for cosmetics, pharmaceuticals and medical devices. PETA India has also reached out to the National GLP Compliance Monitoring Authority (NGCMA), under the Union government's department of science and technology (DST), which issues Good Laboratory Practice (GLP) certificates. According to the body's website, 'GLP-compliance certification is voluntary in nature.' ThePrint reached Palamur Biosciences, Committee for the Purpose of Control And Supervision of Experiments on Animals (CCSEA), Central Drugs Standard Control Organisation (CDSCO) and National Good Laboratory Practice Compliance Monitoring Authority (NGCMA) for comment over email but had not received a response by the time of publication. The report will be updated if and when a response is received. Also Read: Indian laws are letting animals down every day. It's a legal, moral, ethical issue Filing complaints only the first step Asked if flagging the issue to relevant authorities was enough, Aggarwal said, 'Filing complaints with regulatory bodies is only the first step. What matters is the enforcement of existing standards. Without swift and meaningful punitive action, cruelty to animals thrives unchecked.' She called for the lab in Telangana to be shut down, saying, 'We urge government regulators to end the torment of animals imprisoned at Palamur Biosciences. Anything less than the facility's permanent shutdown is a green light for abuse.' To better regulate such facilities, she said, 'authorities must conduct genuinely unannounced inspections without advanced notice, ensure full access to historical records and CCTV footage, protect whistleblowers, and impose serious penalties—not mere warnings—for violations.' India, she added, needs to get out of the 'archaic, cruel, and unscientific animal experimentation business,' citing the example of the the US Food and Drug Administration (FDA) and the US National Institute of Health (NIH) that 'have already begun the long-overdue transition away from animal testing'. 'Notably, earlier this year, the NIH closed down its beagle laboratory, and the US Navy ended all its testing on dogs and cats, which stands in stark contrast to Palamur Biosciences' breeding and testing on beagles and other animals,' Aggarwal said. What PETA India report said—Inside the 'house of horrors' The report, which PETA said was a first-of-its-kind whistleblower exposé, documented the neglect of dogs, pigs, and monkeys used by Palamur Biosciences. The lab is located in Karvena village, Mahabubnagar district. A whistleblower said that, at the lab, being deemed 'useless' meant certain death for the animal. They shared several instances where animals were allegedly killed, including two involving sick dogs—one with a cherry eye and a beagle with a fungal infection. One whistleblower told PETA India that over 100 dogs were killed in a single incident simply because they were no longer considered 'useful'. According to the PETA report, animals were also being subjected to overcrowding and competition for food, resulting in extreme frustration and frequent fights that often caused serious injuries. Above all, basic treatment, proper wound cleaning, and pain management weren't provided by the company. Rough handling of dogs often led to fractures, the report said. Lab workers also showed cruelty while conducting testing, including studies where 'dogs were injected subcutaneously with test compounds'. 'According to a whistleblower, animals developed abscesses, ulcers, and signs of severe pain following these injections,' it said. A whistleblower alleged that, depending on the location of the abscess, further health issues were seen in the dogs. The report further claimed that the laboratory purchased Göttingen minipigs from Denmark, but does not have a license to breed them. When a minipig was found pregnant, the head veterinarian allegedly ordered the killing of the piglets through intracardiac injection. Despite a policy requiring Palamur to provide playtime for pigs, they are only permitted access to enrichment when customers are around, the report alleged. According to the allegations, among the wild rhesus macaques from Rajasthan, some tested positive for zoonotic pathogens, likely monkeypox. The company simply kept quiet and killed the monkeys, risking infection to others, the report claimed. Riju Chanda is an intern with ThePrint (Edited by Sanya Mathur) Also Read: Goldfish in perfume bottle, protected species on sale—DU students' report on horrors of Delhi pet shops
Hans India
17-06-2025
- Health
- Hans India
Animal Protection Organisations Urge Immediate Closure of Palamur Biosciences for Systemic Animal Cruelty and Regulatory Violations
New Delhi: Twenty leading animal protection organisations, who are members of the Federation of Indian Animal Protection Organisations (FIAPO), India's largest network of animal protection groups, have submitted an urgent appeal to the Committee for the Control and Supervision of Experiments on Animals (CCSEA) seeking the permanent closure of Palamur Biosciences Pvt. Ltd. for egregious animal cruelty and repeated regulatory violations. Speaking on behalf of the federation, Bharati Ramachandran, CEO of FIAPO, stated: "We urge the CCSEA to uphold its mandate and act without delay to end the suffering of animals at Palamur Biosciences. The egregious violations reported are not isolated incidents—they represent a complete breakdown of ethics and compliance in animal-based research. We must ensure that cruelty is not the cost of scientific progress." Palamur Biosciences, located in Bhoothpur Mandal, Mahabubnagar, Telangana, has been engaging in severe and systemic mistreatment of animals in violation of national laws and scientific ethics. Video and photographic evidence reveal the following violations: · Severe overcrowding: Close to 1,500 dogs were confined in facilities designed to house no more than 800, resulting in heightened aggression, injuries, and unaddressed trauma. · Unregulated breeding: Dogs were bred excessively and continuously, from 18 months of age to nearly 13 years old, without appropriate rest periods between pregnancies, violating breeding norms. · Inhumane handling: Animals were routinely subjected to rough handling during procedures, with no evidence of pain mitigation. Documented instances include dogs being forcibly confined and injected with painful substances. · Non-compliant euthanasia methods: Euthanasia was conducted without sedation, in direct contravention of CCSEA guidelines. · Unlawful use and transport of primates: Rhesus macaques were reportedly used and transported in violation of regulatory requirements, posing serious public health risks. · Unauthorised breeding and inadequate housing of minipigs: Göttingen minipigs were bred without valid licensing and confined in conditions that lacked required environmental enrichment, breaching both national standards and OECD Good Laboratory Practice principles. These actions constitute clear violations of multiple statutory and regulatory frameworks, including the Prevention of Cruelty to Animals Act, 1960; Breeding of and Experiments on Animals Rules, 1998; Guidelines on the Regulation of Scientific Experiments on Animals, 2007; CPCSEA Guidelines for Laboratory Animal Facility, 2015; Bharatiya Nyaya Sanhita, 2023; OECD Good Laboratory Practice standards; and Medical Devices Rules, 2017. The organisations have called on the CCSEA to take the following actions immediately: 1. Revoke all existing CPCSEA registrations, approvals, and breeding licenses issued to Palamur Biosciences Pvt. Ltd. 2. Instruct the company to cease all ongoing experiments and permanently prohibit future applications involving the use of live animals. 3. Initiate immediate rehabilitation and relocation of all surviving animals in collaboration with reputable sanctuaries and rehoming networks.
