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. This all creates numerous challenges for the market. For the AAV packaging service, what is the titer of the viral particles?

Gene Therapy 52

Gene Therapy Gene Life Science Bioinformatics 52

Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

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Manufacturing Production Contract Manufacturing Contamination 40

FDA Law Blog

OCTOBER 31, 2021

Under SB 343, a product or packaging is not recyclable in California if: It includes components, inks, dyes, adhesives, or labels that prevent its recyclability; It contains intentionally added chemicals identified pursuant to regulations implementing section 42370.2(g)(4) g)(4) of the California Public Resources Code; or.

Packaging 52

Packaging Packaging Containment Production 52

XTalks

OCTOBER 26, 2020

These days, it’s hard to find food, especially processed food, that isn’t encased in some form of packaging. Modern food packaging has allowed for safer, cleaner, more reliable, shelf-stable food – but at what cost? Discarded food, and the packaging it comes in, accounts for nearly 45 percent of waste in US landfills.

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Packaging Packaging Marketing Containment 98

XTalks

DECEMBER 1, 2021

The US Food and Drug Administration (FDA) estimates that nearly 48 million people are sickened by food contaminated with harmful germs each year, with produce being the culprit in many cases. However, it appears to be the first and only at-home food safety testing device on the market. Where the gadget will fit into the $19.5

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Contamination Packaging Packaging Regulation 98

FDA Law Blog

NOVEMBER 22, 2022

coli contamination. Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. Two days before Thanksgiving the following year, the CDC warned U.S. Concurrently, the U.S.

Contamination 52

Contamination Production Manufacturing Packaging 52

Roots Analysis

FEBRUARY 1, 2024

Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products.

Packaging 40

Packaging Packaging Containment Production 40

XTalks

AUGUST 10, 2020

The US Food and Drug Administration (FDA) announced a voluntary phase-out of certain types of grease-proofing agents on paper and paperboard food packaging. This phase-out comes after an FDA post-market scientific review and analysis from studies found bio-persistence of the grease-proofing substances.

Packaging 98

Packaging Packaging Contamination Containment 98

XTalks

FEBRUARY 5, 2021

There are a variety of materials that are used for food packaging, and they serve some very important functions in the food industry. Many of the foods purchased by consumers today are contained in packaging made from materials such as paper, plastic, metal or glass. One of the hallmarks of food packaging is the single-use design.

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Packaging Packaging Contamination Containment 64

pharmaphorum

JUNE 16, 2021

At the same time, living in environments plagued with construction pollution, industrial fumes, and contaminated water, interferes with a child’s mood stability, behavior, and neurological development. Social injustice, poverty, and lack of access to whole foods create nutritionally toxic and depleted food environments.

Medicine 52

Medicine Packaging Packaging Contamination 52

Pharma in Brief

AUGUST 9, 2021

The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. Manufacturing Controls. On-site Evaluations.

Regulation 98

Regulation Drugs Manufacturing Production 98

XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. Both drugs continue to dominate the diabetes and GLP-1 markets. In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing.

Sales 52

Sales Insulin FDA Approval Drugs 52

pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. Namely, these include the backlogs and hassle associated with working with CDMOs or CMOs to develop new products and bring them to market. The future of COD.

Manufacturing 97

Manufacturing Pharma Packaging Packaging Packaging 97

XTalks

JUNE 22, 2023

The Rethink Plastic alliance, in collaboration with a coalition of 81 organizations, is advocating for the integration of effective reuse systems into the European Union’s (EU’s) Packaging and Packaging Waste Regulation. This push aims to mitigate waste produced by single-use plastic takeaway packaging.

Packaging 52

Packaging Packaging Containment Contamination 52

XTalks

MAY 30, 2023

XTALKS WEBINAR: Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems Live and On-Demand: Thursday, June 15, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn about on-body drug delivery systems and addressing their complex global regulatory requirements.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

Roots Analysis

SEPTEMBER 29, 2023

Closed System – To ensure that there is no chance of contamination or leakage of liquid nitrogen used for freezing and storage of goods, single-use bags can be fully sealed and vacuum packed. Easy access to material : To prevent contamination during sample withdrawal, functionally closed access systems must be implemented.

Contamination 40

Contamination Containment Biobanking Packaging 40

Pharmaceutical Technology

FEBRUARY 3, 2023

Cell culture challenges The viral vectors used in the gene therapies currently on the market are produced in adherent human embryonic HEK-293 cell culture. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. link] [2] Tang Q, et al. Biores Open Access. 2020 Oct 16;9(1):219-228. doi: 10.1089/biores.2020.0031.

Genome 244

Genome Genomics Medicine Gene Therapy 244

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, they require adequate cleaning and sterilization before reuse, thereby increasing costs.

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

Pharmaceutical Technology

MAY 11, 2008

Data has long been incorporated into drug packaging to accomplish these goals, but only to a partial degree with embossed lot numbers, expiry dates and even Braille identification in addition to linear bar codes. For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011.

Drugs 130

Drugs Packaging Packaging Contamination 130

Pharmacy Checkers

DECEMBER 12, 2019

The European Union (EU) has similar challenges to us when it comes to drug safety, including inspections of the plants that make pharmaceuticals for the European market. FMD requires that every single prescription drug dispensed in the EU must be verified for authenticity via a mandatory 2D barcode on the packaging.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

Drug Discovery World

AUGUST 16, 2022

Cancer risks also increase in areas with water contaminants or polluted air. This would entail remotely engaging with underserved populations by shipping clinical trial packages directly to patients’ homes. Moreover, the environmental conditions of a locality directly influence the health outcomes of its residents.

Research 52

Research Clinical Trials Clinical Trials Trials 52

Pharmaceutical Technology

MAY 2, 2023

Datwyler is a leading provider of parenteral packaging components and is helping the industry put quality first through the invention of the FirstLine® manufacturing standard. This whitepaper discusses the issue of nitrosamine contamination since 2018 and the response from regulators and industry.

Packaging 130

Packaging Packaging Production Contamination 130

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This includes the rising number of biologic drugs on the market, which are mostly administered parenterally.

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Contamination Packaging Packaging Manufacturing 130

Pharmaceutical Technology

DECEMBER 8, 2022

Forward-thinking suppliers, including packaging component providers, are also looking at how they can improve their processes through digital technologies. Tom Lenaerts is head of global process engineering for Datwyler, a leading supplier of parenteral packaging components such as stoppers and plungers. Free Whitepaper. By Datwyler.

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Manufacturing Packaging Packaging Production 246

Pharmaceutical Technology

JANUARY 12, 2023

That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. Download this whitepaper to find out more about oncology trends and how Baxter’s oncology contract manufacturing facility in Halle, Germany, minimise the risk of cross contamination. A great example is aspirin.

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Production Contamination Development Manufacturing 130

Pharmaceutical Technology

FEBRUARY 3, 2023

There are a number of reasons why OSD forms dominate the market, not least because they are simple to administer, and it is easy to differentiate one OSD product from another. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport. Please check your email to download the Webinar.

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Contamination Manufacturing Containment Production 130

FDA Law Blog

DECEMBER 14, 2023

They observed that unregulated cannabis products have been found to contain fentanyl, high levels of heavy metals, contaminants, and even high delta-9 tetrahydrocannabinol (“THC”) concentrations.

Regulation 59

Regulation Production Contamination Drugs 59

Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Simplicity matters. Bioburden and microbial testing. an antibiotic).

Production 130

Production Manufacturing Development Bioequivalency 130

XTalks

SEPTEMBER 14, 2020

All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. ECONOMIC IMPACT: Canada.

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Vaccination Vaccine Antibody Life Science 92