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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STAT News

APRIL 3, 2023

We hope your journey today is meaningful and productive. 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.

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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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XTalks

AUGUST 4, 2023

The Trader Joe’s recall situation has garnered significant attention in the past week, as the popular retail chain declared three different product recalls during the last week of July. The recalls affect cookies, broccoli-cheddar soup and falafel, raising concerns over possible contamination with foreign objects like insects or rocks.

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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. Recent incidents involving Cronobacter sakazakii infections linked to Abbott’s baby formula resulted in hospitalizations and tragic deaths, prompting product recalls.

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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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XTalks

SEPTEMBER 17, 2020

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products. Fortune Food Product did not respond to Xtalks’ request for comment.

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Pharmaceutical Technology

AUGUST 17, 2022

RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The company is ranked in the 2022 Excellence Rankings in the INNOVATION , PRODUCT LAUNCH and SAFETY categories. has been manufacturing, designing, and innovating since 1984. The Verdict. Northgate Technologies Inc.

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XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

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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.

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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., Related Information.

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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…

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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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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.

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pharmaphorum

JANUARY 30, 2023

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors is also sustaining new growth and transformation in this field.

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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. coli O157:H7 bacteria.

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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.

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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.

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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. Continue to STAT+ to read the full story…

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Medical Xpress

FEBRUARY 16, 2023

Like any other manufactured food product, chocolate can be contaminated if key ingredients or processes break down.

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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. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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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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XTalks

APRIL 11, 2024

As a staple spice in many kitchens, the discovery of elevated lead levels in cinnamon products has prompted a closer look at food safety practices and regulations. Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination.

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XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). While this act is intended to make it easier for consumers with food allergies to identify potential allergens in the products they purchase, many believe it falls short.

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XTalks

MARCH 25, 2022

Nitrosamines are commonly found in drinking water, air and foods such as dairy products, vegetables and cured and grilled meats. 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.

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XTalks

MAY 26, 2022

Mars Wrigley announced a voluntary recall of various candy products after consumers reported thin metal strands in the candy itself or loose in the bag. She brings up several other recent recalls and explains why metal contamination is such a prevalent occurrence in the food and beverage industry.

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XTalks

AUGUST 31, 2023

Also in this episode, Sydney talks about MenuTrinfo, a private company that established its own certification programs to indicate that certain food products are free from specific allergens. MenuTrinfo operates a heavily vetted ‘Certified Free From’ scheme with standards that have raised the bar for allergen-free products.

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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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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.

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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.

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pharmaphorum

MAY 5, 2022

Assuring end-patient safety through holistic contamination control. Discuss expert guidance and explore the regulations concerning objectionable organisms in drug products. Discuss expert guidance and explore the regulations concerning objectionable organisms in drug products. Event Hashtag: #PharmaMicroWC.

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pharmaphorum

FEBRUARY 3, 2022

Harnessing existing methods and novel tools in microbial control to assure continuity in product quality and patient safety. 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.

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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?

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FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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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.

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XTalks

DECEMBER 20, 2021

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. 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.

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FDA Law Blog

JULY 18, 2023

Geography of Manufacturing Sites OPQ reports that as of October 2022, CDER’s manufacturing site catalog listed 4,814 facilities, a 12% increase over 2018. That leaves 60% that manufacture at least one application product. OPQ attributes that in part to the decrease in the use of injectable products as the PHE waned.

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