Why small particles matter: Manufacturing and micro-material contamination
Pharmaceutical Technology
MARCH 6, 2024
To protect patient safety and reduce recall risks, drug manufacturers must reduce particle contamination sources wherever possible.
FDA cites Emergent for failings at plant that contaminated J&J doses
Bio Pharma Dive
APRIL 22, 2021
A recent nine-day inspection by agency officials found numerous breaches of manufacturing standards and inadequate training for factory employees.
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Keeping cleanrooms clean: Choosing the right laboratory equipment is key
Bio Pharma Dive
APRIL 15, 2024
Because live cell and tissue products are extremely sensitive to contamination from microorganisms, viral particles or other airborne impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.
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GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns
Fierce Pharma
SEPTEMBER 25, 2023
GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns esagonowsky Mon, 09/25/2023 - 12:26
Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection
Fierce Pharma
SEPTEMBER 19, 2024
From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more. 26 to Sept.
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FDA cracks down on China's Hengrui in scathing manufacturing write-up
Fierce Pharma
JUNE 6, 2024
When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. |
CMO Moves: Regulatory catalysts for drug manufacturing-April
Pharmaceutical Technology
JULY 14, 2022
Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.
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Indian pharma manufacturing: rising investment in Andhra Pradesh
Pharmaceutical Technology
APRIL 4, 2023
Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. © GlobalData.
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Mars Recalls Select Skittles, Starbust and Life Saver Gummies over Possible Metal Contamination
XTalks
MAY 19, 2022
According to the company, products were manufactured by a third party and subsequently distributed across North America. Since metal contamination is a common issue in food production, resulting in expensive recalls and lawsuits, the FDA has implemented metal detection standards to ensure the same principles are followed for all companies.
STAT+: Major Indian generic drugmaker closes a U.S. facility after years of manufacturing problems
STAT News
AUGUST 22, 2022
After a decade of manufacturing problems, a U.S. federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. However, the U.S. Continue to STAT+ to read the full story…
IN FOCUS: Northgate Technologies
Pharmaceutical Technology
AUGUST 17, 2022
NTI have tackled this problem through the introduction of its NEBULAE® SRS system , which filters and recycles the air in surgical theatres, removing potentially harmful contaminates. has been manufacturing, designing, and innovating since 1984. Pioneers in minimally invasive surgical technology, Northgate Technologies Inc.
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Virtual and augmented reality: Bringing the future to pharma manufacturing
pharmaphorum
MARCH 22, 2022
In this article, Ben Hargreaves asks whether there is particular potential for the technologies to revolutionise staff training and reduce costs in pharma manufacturing. The importance of manufacturing. the streamlining of pharma manufacturing in the 21st century. Taking manufacturing to the next level.
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Flexible grinding processes for sterile nanopharmaceutical manufacturing
Pharmaceutical Technology
OCTOBER 26, 2022
Nano-based delivery systems are on the rise, as they enable manufacturers to deliver therapeutic agents to specific targeted tissue in a more controlled manner. Regulations and guidelines for nanopharmaceuticals are still relatively in their infancy, including for cleaning processes and the prevention of cross-contamination.
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FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too
Fierce Pharma
APRIL 10, 2024
FDA chided Kilitch Healthcare India for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses. . | In a four-observation warning letter issued this week, the U.S.
‘Human error’ at CDMO blamed for contamination of Moderna COVID-19 vaccine
BioPharma Reporter
OCTOBER 6, 2021
A probe has identified 'human errorâ at the Spanish contract development and manufacturing organization, Rovi, as the reason for the presence of metal contaminants in Moderna COVID-19 vaccine doses, leading to Japanese authorities withdrawing 1.6 million doses of the shot in August.
STAT+: Pharmalittle: FDA slams company recalling eye drops over manufacturing issues; U.S. funds massive Alzheimer’s research database
STAT News
APRIL 3, 2023
Your tips and insights help the world go around… Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated , according to a U.S. Food and Drug Administration inspection report obtained by STAT.
COVID-19 Vaccine Manufacturing Mishap Spurs C-Suite Shakeup at Emergent
BioSpace
APRIL 29, 2021
Battered by vaccine manufacturing mishaps that led to the contamination of 15 million doses of the Johnson & Johnson vaccine, Emergent BioSolutions is shaking up its leadership to ensure such errors do not occur again.
STAT+: ‘A cascade of failures’: FDA cites Indian drugmaker for numerous quality control problems
STAT News
JANUARY 19, 2023
In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses. Continue to STAT+ to read the full story…
STAT+: FDA report details problems at Global Pharma plant involved in eye drop recall
STAT News
MARCH 31, 2023
Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated, according to a Food and Drug Administration inspection report obtained by STAT.
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Antibiotic residues in water a threat to human health
Medical Xpress
JANUARY 4, 2023
The researchers also determined the relative contribution of various sources of antibiotic contamination in waterways, such as hospitals, municipals, livestock, and pharmaceutical manufacturing.
STAT+: FDA scolds Sun Pharmaceutical for serious quality control problems at a key plant in India
STAT News
JANUARY 10, 2023
Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems.
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Lead in Food: Regulatory Imperatives and Industry Responsibilities
XTalks
AUGUST 12, 2024
Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. FDA’s Regulatory Framework on Lead in Food Lead contamination in food can arise from various environmental sources, including past usage of lead in paint, gasoline and plumbing materials.
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DeepVerge’s nanochip-based COVID breath test could be ready this year
pharmaphorum
MARCH 19, 2021
Since the third quarter of last year DeepVerge’s scientists have been working to transform an AI-based water contamination detection system into a unit that tests for the presence of the coronavirus. A femtogram is 0.000000000000000001 kilograms.
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Superheated Steam Might Be Used to Sterilize Dry Food Manufacturing Plants
XTalks
MAY 18, 2023
Cornell University researchers have been making strides in the development of a revolutionary tool to combat dangerous pathogens in commercial dry food manufacturing plants. Food manufacturers use steam for tasks like dehydration, distillation, pasteurization and cooking, which helps preserve the taste and texture of their offerings.
Avoiding a global chocolate disaster: How tracing and recalls avoided a worldwide Salmonella outbreak
Medical Xpress
FEBRUARY 16, 2023
Like any other manufactured food product, chocolate can be contaminated if key ingredients or processes break down.
Opinion: Report: More people should be tested for potential exposure to ‘forever chemicals’
STAT News
AUGUST 15, 2022
communities. Although researchers have known about the impact of these chemicals for years, there has been little guidance available for clinicians.
AvKARE Recall: Erectile Dysfunction Drug and Antidepressant Mistakenly Packaged Together
XTalks
DECEMBER 14, 2020
AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.
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Emergent Hid Evidence of Covid Vaccine Problems at Plant, Report Says
NY Times
MAY 10, 2022
The report sheds new light on executives’ worries about deficiencies in the company’s quality control systems at its troubled Baltimore plant; no contaminated doses were ever released to the public.
Fabrazyme litigation back in play for Sanofi's Genzyme as appeals court overturns dismissal of 2020 lawsuit
Fierce Pharma
FEBRUARY 20, 2024
It’s been 15 years since Genzyme began rationing the Fabry disease treatment Fabrazyme after a shortage caused by contamination at a manufacturing site, marking the start of many years of litigatio | Sanofi's Genzyme was accused of causing injuries after contaminated doses of its Fabry disease drug led to a shortage, during which the company rationed (..)
Salmonella Control: Comparing US and EU Regulations for Poultry
XTalks
JULY 30, 2024
The US Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) declared Salmonella an adulterant in raw breaded stuffed chicken products when contamination levels exceed one colony-forming unit (CFU) per gram. This approach emphasizes stringent testing and preventive measures at earlier stages of the supply chain.
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Quality by design with a focus on biosimilars
Pharmaceutical Technology
OCTOBER 28, 2022
It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.
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Federal judge enters consent decree against New Jersey raw animal food manufacturer
The Pharma Data
MARCH 29, 2022
an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Food and Drug Administration (FDA) announced today that Bravo Packing, Inc.,
FDA Issues First Injunction of its Product Safety Rule
XTalks
SEPTEMBER 17, 2020
Sprouts can carry a risk of foodborne illness if they are contaminated, and unlike other fresh produce, the warm, moist conditions required to grow sprouts are ideal for the rapid growth of bacteria, including Salmonella , Listeria , and E. No confirmed illnesses related to Fortune Food’s products have been reported to the FDA.
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Pharma pollution ‘threatens world environment, health’; study
pharmaphorum
FEBRUARY 15, 2022
It found that the highest contamination levels were in in sub-Saharan Africa, south Asia, and South America, typically in areas of low- to middle-income countries that have poor wastewater management, rubbish dumping along river banks, and pharmaceutical manufacturing plants.
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How API CMOs can improve containment capabilities without facility acquisition
Pharmaceutical Technology
NOVEMBER 17, 2022
According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities.
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Modernizing cell culture processes for the next wave of genomic medicine
Pharmaceutical Technology
FEBRUARY 3, 2023
CAR T based therapies manufactured with lentiviral vectors are also on the rise, points out Clive Glover, PhD, General Manager, Pall Corporation. Rather, he believes adaptation to suspension-based systems will be an important evolution in AAV manufacturing. For example, researchers have developed a two-plasmid cotransfection system.
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New Netflix Food Documentary Exposes America’s Faulty Food Safety System
XTalks
AUGUST 7, 2023
coli outbreak between 1992 and 1993 that claimed the lives of four children who had eaten contaminated burgers from the fast-food chain Jack in the Box. The spotlight frequently fell on corporate executives and government regulators in the Netflix food documentary, these being the usual suspects behind food contamination.
The Advantages and Challenges of Next Generation Sequencing in Food Safety Testing
XTalks
MARCH 10, 2022
Traditional food safety testing methods used in manufacturing facilities are inconsistent, time consuming and often require trained technicians. So, if a food manufacturer identifies a positive Salmonella result in its facilities, the impact of the positive result differs greatly depending on whether it is pathogenic or not.
API landscape in 2022: Drivers and solutions for small molecules
Pharmaceutical Technology
SEPTEMBER 15, 2022
Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. This suggests a move towards high-value specialised manufacturing. This adds costs and time to the processes involved.
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How Common Is Salmonella in Chicken? New USDA Regulations Target Frozen Products
XTalks
MAY 3, 2024
Approximately one in every 25 chicken packages at grocery stores is contaminated with Salmonella. Other food products can also be contaminated with Salmonella. coli , initiated after deadly outbreaks linked to contaminated ground beef, which resulted in a reduction of related illnesses by more than 50 percent.
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New Food Traceability Rule Sparks Concerns Among Grocery Trade Groups
XTalks
NOVEMBER 22, 2022
Last week, the US Food and Drug Administration (FDA) issued its final rule on Requirements for Additional Traceability Records for Certain Foods , which includes food traceability protocols for a variety of food products susceptible to contamination. Related: Here’s How the FDA is Making it Easier to Trace Foods.
Outsourcing Biologics Fill Finish Manufacturing : Streamlining the Production Process for Biopharmaceutical Companies
Roots Analysis
APRIL 15, 2024
Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. Notable examples of fill finish manufacturing companies equipped with SA25 aseptic filling workstation include ( in alphabetical order ) Emergent Bioservices, PCI Pharma Services, Singota Solutions and WuXi Biologics.
Planning appeal blocks Lilly’s €400m plant in Ireland
pharmaphorum
NOVEMBER 6, 2022
Eli Lilly plans for a new biopharmaceutical manufacturing facility in Ireland that will be used to produce active ingredients for its biologic medicines, including its new Alzheimer’s candidate donanemab, has been blocked by a planning objection.
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Here’s What You Need to Know About Coca-Cola’s Recall
XTalks
DECEMBER 20, 2021
Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants. coli , listeria or salmonella contamination in raw produce and meat, this is not the first beverage-related recall this year. While recalls tend to address E.
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