Pharma Mirror

JANUARY 6, 2021

Families are taking a hard look at how baby formulas’ ingredients impact their children’s health and development. In the United States, the Food and Drug Administration (FDA) set out some very broad guidelines concerning nutrients that should be included in baby formula.

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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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Roots Analysis

MAY 24, 2024

In the dynamic landscape of the healthcare sector, the evolution of drug delivery systems plays a significant role in transforming the management of chronic diseases. They are generally used in combination with primary containers, such as prefilled syringes and cartridges. These allow precise and consistent delivery of a fixed dosage.

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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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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

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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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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Pharmaceutical Technology

MAY 10, 2023

Microparticles can be present as a contamination of products such as pharmaceuticals and electronics, or as an air pollutant. Within the pharmaceutical industry, it is critical to measure particle size as it influences surface area and porosity, impacting a drug’s bioavailability, effectiveness, and shelf life.

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XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus. Targeted Antiviral Treatment.

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XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. extractables and leachables).

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Roots Analysis

SEPTEMBER 29, 2023

A user can easily handle the container and pre-installed tube combinations without the need for additional tools, equipment, or validation. A user can easily handle the container and pre-installed tube combinations without the need for additional tools, equipment, or validation.

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Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. However, this needle system does not contain a proper locking system, therefore, increased the chances of leakage.

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XTalks

NOVEMBER 2, 2021

They obtained 64 samples of hamburgers, fries, cheese pizza, chicken burritos and chicken nuggets from various chains and found that over 80 percent contained the phthalate di-n-butyl phthalate (DnBP), while 70 percent contained di(2-ethylhexyl) phthalate (DEHP), both of which have been linked to reproductive health issues.

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Pharmaceutical Technology

JANUARY 12, 2023

. – about the advantages and challenges of product lyophilization, developing lyophilization processes on site at their Bloomington, Indiana plant, and the importance of continuing research. Case in point: the recently developed mRNA-based therapeutics which require cold storage for stability.

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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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XTalks

SEPTEMBER 13, 2022

While the US Food and Drug Administration (FDA) would normally issue a recall, no recall was issued because the products are no longer available for purchase. The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022,” the FSIS stated in a public health alert. “The Coli illness.

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Pharmaceutical Technology

APRIL 16, 2023

Autoinjectors have revolutionised the convenient delivery of low-volume parenteral drugs. But with the advent of injection site absorption enhancers, drug delivery device innovations, as well as the recent primary container options, the practical subcutaneous self-administration of large-volume parenterals is becoming possible.

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XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

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STAT News

NOVEMBER 3, 2022

The companies allege Moderna’s vaccine uses their technology for a drug-delivery system without permission. Citing The single-dose vaccine candidate is a combination of Pfizer’s mRNA-based flu shot and the Omicron-tailored Covid-19 booster shot developed by both companies.

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Drug Discovery World

JANUARY 19, 2023

Plasmid DNA: a critical reagent pDNA is the starting material for the development of many cell and gene therapy products, irrespective of the mode of action. Figure 1 shows the development pathways for non-viral and viral vector gene therapies, and cell therapy and illustrates the critical role pDNA plays in their development.

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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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Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. Currently mostly outsourced, there are signs that CMOs are beginning to make investments in containment capabilities, to capture emerging opportunities.

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XTalks

MAY 30, 2023

The VTT Technical Research Centre of Finland has addressed this issue by developing a fully recyclable, modular ECG patch constructed from VTT’s novel cellulose e-skin material. The patch itself is made of biodegradable nanocellulose and contains no plastic additives.

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XTalks

AUGUST 7, 2023

Ycanth (cantharidin) topical solution, developed by Verrica Pharmaceuticals Inc., has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. What is Molluscum Contagiosum? How Does Ycanth Work?

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Drug Discovery World

MAY 11, 2023

However, the increased complexity and diversity involved in the development and manufacturing of gene therapies and vaccines can cause challenges when it comes to determining the quality of the final product, particularly around the detection of impurities. As efficient as ELISAs are in HCP quantification, they have several limitations.

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Roots Analysis

FEBRUARY 1, 2024

Cold chain is a three-fold concept, involving certain aspects that can be co-related to science, technology, and process development. The concept of temperature controlled packaging initiated in 1817 in England, when the first commercial cardboard box was developed.

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The Pharma Data

DECEMBER 30, 2020

Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. Food and Drug Administration said. Below are newsworthy items compiled by HealthDay staff: U.K. Shane Erickson Inc. Shane Erickson Inc.

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FDA Law Blog

FEBRUARY 21, 2023

A new pathway could also provide access and oversight for animal CBD-containing products. As with CBD in dietary supplements and human food, a new regulatory pathway could provide access and oversight for CBD-containing animal products. Meanwhile, dietary supplements and foods containing CBD continue to be marketed and consumed.

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Drug Discovery World

AUGUST 10, 2022

And as researchers study all of these factors, they are also discovering that CAR T cell development and manufacturing require a new approach to quality control to ensure their safety and efficacy. Developing the first CAR T cell therapy. These treatments have shown success in treating a variety ofcancers 4.

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Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. Aciclovir (acyclovir) is an antiviral drug, which stops the production (replication) of the virus at the site of infection. Generic Zovirax cream for cold sores As previously mentioned, Zovirax cream contains 5% of aciclovir. What is Zovirax cream?

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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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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. Ugur Sahin, CEO, and Prof.

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Drug Discovery World

FEBRUARY 8, 2023

Partially-filled capsids may also be present, and contain packaged process-related impurities or truncated genetic material. As such, characterising the proportions of empty, partially-filled, and full AAV capsids is vital for determining sample quality and estimating efficacy during both process development and for quality control.

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FDA Law Blog

NOVEMBER 30, 2022

According to the Realtor, these CIP qualification discrepancies “may lead to contamination” and “…over time [lead to] to adulterated [Gamunex] product and significant risk of patient harm.” 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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Roots Analysis

SEPTEMBER 20, 2023

Considering the vast potential of cellular therapies in the treatment of rare disorders and sufficient body of evidence validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, cell therapy has garnered considerable attention of players engaged in the healthcare industry, in the past few years.

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Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. RFID has other advantages in that it can be used to monitor conditions such as temperature during transport of the drugs.

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The Pharma Data

FEBRUARY 18, 2022

Food and Drug Administration announced it is investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections. A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter. “As

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