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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Scienmag

MAY 14, 2021

Credit: University of Nottingham A new method to analyse the blood thinning drug Heparin has been developed that can pinpoint contaminants more accurately and quickly, providing greater quality control and safety.

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The Pharma Data

MAY 3, 2021

Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . .

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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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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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pharmaphorum

AUGUST 4, 2022

Training and development. Staff development and training programmes were largely on pause during the pandemic. Businesses need to ensure they prioritise the recruitment and development of staff to help ensure longevity and survival. Embrace mobile learning.

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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. Dissect the framework of a robust Global Contamination Control Program and how to approach implementing a holistic CCS. Event Hashtag: #PharmaMicroWC.

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pharmaphorum

JULY 22, 2022

for an Improved, Efficient and Contaminant-Free Cleanroom. From the new operating practices that keep the product as sterile as possible, to the developments in technology that are enabling this to happen. Key Reasons to attend: Learn how to maximise the latest cleanroom technologies to modernise your contamination control strategy.

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Roots Analysis

NOVEMBER 11, 2023

This concerning development has been traced back to the utilization of EzriCare Artificial Tears Eye Drops. This recall was instigated in concurrence with the Food and Drug Administration’s (FDA) recommendation, acknowledging a potential microbial contamination of the product. Is EzriCare the Only Brand with Challenegs?

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World of DTC Marketing

FEBRUARY 28, 2021

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. So should we forget all that because they developed a COVID vaccine?

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pharmaphorum

FEBRUARY 3, 2022

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. Uncover principles in best-practice and the benefits of a robust contamination control strategy. Who Should Attend?

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Drug Discovery World

MAY 19, 2023

Therapeutic developers face significant challenges in purifying cell and gene therapy (CGT) modalities. Current processes rely on solutions developed for monoclonal antibodies that are not fit for purpose for viral vector purification, resulting in low yields, long processing times, and high costs.

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Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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XTalks

FEBRUARY 8, 2024

The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5

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pharmaphorum

FEBRUARY 15, 2022

The findings point to a “threat to environmental and global health,” say the scientists, who found that paracetamol, antibiotics epilepsy drug carbamazepine, metformin for diabetes and other compounds like caffeine and nicotine were found in samples from around the world – including in Antarctica.

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Drug Discovery World

OCTOBER 5, 2022

DDW Editor, Reece Armstrong, sits down with Brinter CEO Tomi Kalpio to learn about the company’s approach to bioprinting and how it can be used throughout drug discovery. . RA: How can bioprinting be used to shorten drug discovery timelines? . This allows researchers to identify the best individual drugs to treat the disease. .

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XTalks

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). What Is Anthrax? anthracis exposure.

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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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Drug Discovery World

FEBRUARY 8, 2024

The event aimed to help the audience understand the AAV workflow, from upstream methods for AAV production and validation to downstream analysis of the packaged product for enhanced therapeutic development. Questions were fielded from the audience, which included: What analysis will be performed to evaluate host or other DNA contamination?

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Drug Discovery World

JANUARY 30, 2024

COP is a very clean resin, free of metals and other contaminants that can impact cells, enzymes and other bioactive entities, especially when compared to polystyrene (PS). The post High-performance microplates for discovery sciences appeared first on Drug Discovery World (DDW).

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XTalks

JUNE 7, 2022

They are caused by bacteria, viruses, parasites or chemical substances entering the body through contaminated food or water. An estimated 420,000 people in the world die every year after eating contaminated food, with children under five years old carrying 40 percent of the foodborne disease burden. How to Get Involved .

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FDA Law Blog

NOVEMBER 1, 2022

Brevig, Senior Regulatory Device and Biologics Expert — On October 26, 2022, US Pharmacopeia (USP) Biologics Stakeholder Forum held a workshop on “Collaborating to solve CMC challenges and support efficient development of lentiviral-mediated CART cell therapies.” Have qualified potency assay(s) prior to conducting your pivotal study.

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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. Adding to these factors is that oncology accounts for the majority of marketed, contained drugs.

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Drug Discovery World

OCTOBER 3, 2023

The event aimed to help the audience understand the AAV workflow, from upstream methods for AAV production and validation to downstream analysis of the packaged product for enhanced therapeutic development. Questions were fielded from the audience, which included: What analysis will be performed to evaluate host or other DNA contamination?

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Pharmaceutical Technology

NOVEMBER 15, 2022

Manufacturers are actively looking at ways they can improve drug delivery through well-designed parenteral packaging systems, and the choice to deploy prefilled syringes for more and more injectable drug products is a key part of this push. As such, NeoFlex plungers are ideal for highly sensitive, large molecule drugs.

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pharmaphorum

DECEMBER 7, 2022

Pharma companies involved in the sale of heartburn therapy Zantac have won a key battle in litigation brought by patients who claim the drug caused them to develop cancer.

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pharmaphorum

DECEMBER 16, 2021

Key Reasons to Attend: Discover case studies in establishing holistic Contamination Control Strategies and Real-Time Viable Air Particle Counting with leaders in the pharmaceutical industry. Discuss the latest developments in the detailed, rapid detection of microbes in pharmaceutical water. Download the brochure at: [link].

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Drug Discovery World

JANUARY 20, 2023

COP is a very clean resin, free of metals and other contaminants that can impact cells, enzymes and other bioactive entities, especially when compared with polystyrene (PS). The post High performance microplates for discovery sciences appeared first on Drug Discovery World (DDW).

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XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

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XTalks

MAY 11, 2023

All the infants had been fed baby formula manufactured at the same Abbott Laboratories plant in Sturgis, Michigan, triggering an extensive investigation by the US Food and Drug Administration (FDA) and ultimately stopping production at the facility for months.

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Drug Discovery World

MAY 22, 2023

While the global economic landscape faces a major crisis and biotech is not recession-proof, cell and gene therapy (CGT) has continued to progress with acquisitions, breaking ground on new facilities and approvals across the year – not limited to the breakout of the world’s most expensive drug. million per dose.

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The Pharma Data

NOVEMBER 30, 2020

The voluntary testing method developed by industry is not sensitive enough to screen for asbestos when compared to electron microscopy, the group said. “It’s troubling to think how many Americans have been using talc-based cosmetics products potentially contaminated with asbestos,” Leiba said in an EWG news release.

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pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

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XTalks

NOVEMBER 24, 2022

After many years of research and development, innovation and anticipation, lab-grown meat has been approved by the US Food and Drug Administration (FDA). In this episode of the Xtalks Food Podcast, Sydney talks about the historic approval, which was granted to San Francisco-based startup UPSIDE Foods to sell its lab-grown chicken.

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Camargo

AUGUST 5, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. Over about three pages, 13 questions were posed.

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Drug Discovery World

MARCH 21, 2023

The work promises to reduce the threats of viral contamination when harnessing bacteria to produce medicines such as insulin as well as other useful substances, such as biofuels. Currently, viruses that infect vats of bacteria can halt production, compromise drug safety, and cost millions of dollars. “We

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The Pharma Data

DECEMBER 28, 2020

(NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company with Phase 3 programs in presbyopia, myopia and mydriasis, today announced that it has submitted a New Drug Application (NDA) to the U. Food and Drug Administration (FDA) for MydCombi , a unique fixed combination mydriatic (pupil dilation) agent. About Eyenovia, Inc.

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