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.
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
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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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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.
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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Johnson & Johnson Pulls Neutrogena and Aveeno Spray Sunscreens Over Benzene Contamination
XTalks
JULY 16, 2021
Johnson & Johnson is recalling sunscreens from two of its popular brands over concerns of carcinogenic benzene contamination. Therefore, levels should be monitored at different stages of production to avoid harmful benzene contamination. Growing Contamination Issues. Despite this, contamination issues still persist.
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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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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…
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.
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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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.
‘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.
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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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.
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.
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 (..)
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.
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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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.,
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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Advancements In Automation Of Manufacturing Processes: Key Value Driver For Escalated Interest In The Cell Therapy Domain
Roots Analysis
SEPTEMBER 20, 2023
The focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. It is worth noting that manufacturing process biologics and cell therapies is considerably complex when compared to small molecule drugs. The key steps involved in the supply chain of cell therapy manufacturing are presented below.
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+: ‘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…
Single-use Bioreactor: An Indispensable Component for Biopharmaceutical Manufacturing
Roots Analysis
OCTOBER 24, 2023
The limitations of stainless-steel bioreactors such as high risk of contamination, process related challenges and high operational cost have prompted innovators to develop more advanced single use bioreactor in order to meet the rising demand for safe and efficacious biotherapeutics.
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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6th Annual Pharmaceutical Microbiology USA Conference
pharmaphorum
JANUARY 30, 2023
Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.
Worst Food Safety Scandals of 2023
XTalks
NOVEMBER 23, 2023
Salmonella Outbreak from Poultry — The US A widespread Salmonella outbreak linked to contaminated poultry affected thousands across multiple states this year. It also encouraged a citizen petition to make it illegal to sell poultry contaminated with any one of 31 strains of Salmonella. Coli Daycare Outbreak — Canada In September, an E.
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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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Advancements in Automation of Processes: Key Value Driver for Escalated Interest in Cell Therapies Manufacturing Domain
Roots Analysis
JANUARY 12, 2023
The focus of stakeholders has now shifted to optimizing the cell therapies manufacturing process. For the success of cell-based therapies , an effective manufacturing platform and a robust supply chain model is imperative. The key steps involved in the supply chain of cell therapies manufacturing are presented below.
10 of the Worst Food Safety Scandals in Recent History
XTalks
APRIL 17, 2023
The causes of these events varied, from contaminated food and water to zoonotic diseases and poor hygiene practices. It was caused by contaminated ice cream products manufactured by Blue Bell Creameries, a popular ice cream company based in Texas. Related: Here’s Why Raw Flour is Linked to Foodborne Illness Outbreaks 1.
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.
5th Annual Pharmaceutical Microbiology West Coast Conference
pharmaphorum
MAY 5, 2022
Assuring end-patient safety through holistic contamination control. Dissect the framework of a robust Global Contamination Control Program and how to approach implementing a holistic CCS. Workshop Leaders: Ziva Abraham, President, Microrite and Morgan Polen, SME Cleanroom Contamination Control, Microrite.
Mars Recalls Various Skittles, Starburst and Lifesavers + Kidfresh Offers Frozen Kid’s Meals with Hidden Vegetables
XTalks
MAY 26, 2022
In this episode of the Xtalks Food Podcast, Sydney talks about the latest Mars recall, which included Starburst, Skittles and Life Savers gummies that were manufactured by a third party and distributed across North America. Kidfresh: The Better-For-You Kid’s Brand with Hidden Veggies.
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.
EzriCare Eye Drops Recall: Unveiling a Nationwide Health Crisis
Roots Analysis
NOVEMBER 11, 2023
This recall was instigated in concurrence with the Food and Drug Administration’s (FDA) recommendation, acknowledging a potential microbial contamination of the product. Berne’s MSM Drops and LightEyez MSM Eye Drops, both of which tested positive for bacterial contamination. Is EzriCare the Only Brand with Challenegs?
Accuretic Blood Pressure Drug and Two Generics Recalled by Pfizer Over Carcinogen Impurities
XTalks
MARCH 25, 2022
Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” the company stated in a news release. Last summer, Pfizer recalled a dozen lots of its smoking cessation drug Chantix due to nitrosamine contaminants.
Lead in Cinnamon: A Rising Concern for Food Safety
XTalks
APRIL 11, 2024
Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.
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.
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.
Trader Joe’s Recall 2023: Multiple Products Under the Microscope
XTalks
AUGUST 4, 2023
The recalls affect cookies, broccoli-cheddar soup and falafel, raising concerns over possible contamination with foreign objects like insects or rocks. ” The Trader Joe’s recall appears to be a voluntary move , a common practice amongst companies facing contaminated food products. .”
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SMi’s 5th Annual Pharmaceutical Microbiology East Coast Conference
pharmaphorum
FEBRUARY 3, 2022
Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches. Uncover principles in best-practice and the benefits of a robust contamination control strategy. Who Should Attend?
HPAPIs – Current Interest of the Pharmaceutical Industry
Roots Analysis
OCTOBER 24, 2023
Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.
BioNTech introduces first modular mRNA manufacturing facility to promote scalable vaccine production in Africa
The Pharma Data
FEBRUARY 18, 2022
The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. The manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer.
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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