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. Containment challenges.

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XTalks

AUGUST 12, 2024

Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. FDA’s Regulatory Framework on Lead in Food Lead contamination in food can arise from various environmental sources, including past usage of lead in paint, gasoline and plumbing materials.

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Contamination Compliance Regulation Production 105

Sciensano

APRIL 18, 2023

In order to reduce the amount of packaging waste, the zero-waste trend (bying food in bulk) has recently developed. It is characterisez by the purchase, transport and storage of food using its own containers. But is this trend safe? Reducing packaging waste without compromising safety is possible thanks to your contribution!

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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. Particle size is monitored in quality control as well as the development of active pharmaceutical ingredients (APIs). Particle analysis on a micro-scale is a significant topic in several fields of application.

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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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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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Packaging Packaging Containment Production 98

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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Contamination Manufacturing Production Containment 52

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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Vaccination Vaccine Production Manufacturing 105

Pharmaceutical Technology

MAY 11, 2008

Over the last three to five years technology has been developed that makes it possible to track and trace pharmaceutical units, even down to item level. In the US solid dosage forms are distributed as containers of tablets and these can only be coded on the container and not on a per-item basis.

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Roots Analysis

JANUARY 27, 2025

The development of cell therapy products requires a robust population of cells that can be subjected to genetic alterations, without being damaged in this process. Such procedures require sterile and higher-grade clean rooms, along with regular checks on containment levels. This figure presents the cell therapy manufacturing steps.

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Manufacturing Contamination Production Gene Therapy 40

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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STAT News

NOVEMBER 3, 2022

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. Pfizer and BioNTech have started an early-stage study to evaluate a combination vaccine targeting Covid-19 and influenza , Reuters notes.

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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. The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment.

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Manufacturing Production Containment Contamination 130

pharmaphorum

JANUARY 24, 2022

The expanding production of high potency APIs, along with the increase in associated toxicities, are driving requirements for more effective containment solutions and much-needed guidelines to ensure worker safety. Assess engineering containment controls, from isolators and barriers to fully automated lines.

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Containment Engineer Contamination Manufacturing 52

Pharmaceutical Technology

APRIL 16, 2023

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. mL or less and use a prefilled syringe (PFS) with a staked needle as the drug’s primary container.

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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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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

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.

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Contamination In-Vitro Production Containment 52

Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. delivery Sale Zovirax Cold Sore Treatment Cream, Tube 2 g Zovirax contains aciclovir, an anti-viral treatment; always read the label Fights the cold sore virus Works at the tingle and blister £6.19 −£1.60 £4.59 What is Zovirax cream?

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Containment Pharmacy Sales Drugs 98

XTalks

AUGUST 7, 2023

Ycanth (cantharidin) topical solution, developed by Verrica Pharmaceuticals Inc., This condition is marked by the appearance of small, raised lesions known as mollusca, which usually develop on the body. Immunocompromised individuals are particularly vulnerable to complications and may develop larger lesions.

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pharmaphorum

JUNE 8, 2022

Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0 Bioprocess Research & Development. Led by: Richard Denk, Senior Consultant Aseptic Processing & Containment, Skan AG. Process Leaders.

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XTalks

SEPTEMBER 14, 2020

This makes it a popular choice for processed food containers, dairy products, and even pet food products. Foods packaged with aluminum are safe from bacterial contamination, oxidation, as well as moisture and light, which can compromise product integrity. High Degree of Barrier Protection. Lightweight.

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Packaging Packaging Production Branding 85

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.

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Packaging Packaging Containment Production 52

Roots Analysis

MAY 24, 2024

They are generally used in combination with primary containers, such as prefilled syringes and cartridges. These autoinjectors offer several advantages, including simplified drug administration process, safer injection, reduced risk of contamination and minimized maintenance ( due to elimination of cleaning and sterilization steps ).

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Roots Analysis

OCTOBER 24, 2023

Different Types of HPAPIs The new generation of APIs being developed are highly complex in nature, including peptides, HPAPIs, oligonucleotides and sterile APIs. This precaution is taken to prevent any potentially harmful contaminant from escaping the production area.

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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.” These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility.

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FDA Approval Manufacturing Compliance Contamination 72

Cloudbyz

APRIL 9, 2023

By implementing recycling programs and using reusable containers, it is possible to significantly reduce the amount of waste generated. For example, using reusable containers for shipping materials can reduce the amount of packaging waste.

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Clinical Trials Clinical Trials Trials Biohazard 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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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. Each module is built of six ISO sized containers (2.6m Together with BioNTech’s Co-Founders Prof. Ugur Sahin, CEO, and Prof.

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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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Drug Delivery Contamination Drugs Production 40

Roots Analysis

SEPTEMBER 20, 2023

In fact, owing to the various therapeutic applications, the government in different nations have legalized various pharmaceutical compositions containing cannabis for medical use. Cannabis-infused products primarily contain the cannabinoids cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC).

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The Pharma Data

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. 28, 2021 11:00 UTC. About MultiStem ®. About Athersys.

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The Pharma Data

DECEMBER 28, 2020

MydCombi was developed to address several needs of the eye care practitioner’s office. With no protruding parts and recessed nozzle and shutter, Optejet’s design enables touch-free mydriasis and helps reduce the risk of cross contamination.”. The NDA submission was based on the MIST-1 and MIST-2 studies. About Eyenovia, Inc.

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Roots Analysis

SEPTEMBER 20, 2023

Further, the development of cell therapy products require a robust population of cells that can be subjected to genetic alterations, without being damaged in this process. In addition, the technology platforms used for the development of such advanced therapy medicinal products (ATMPs) need to be approved by regulatory authorities.

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Roots Analysis

JUNE 6, 2024

Autoinjectors Market Manufacturers & Current Landscape Presently, close to 150 autoinjectors have been commercialized / being developed by more than 50 players for the treatment of various therapeutic areas, including diabetes, multiple sclerosis and rheumatoid arthritis.

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The Pharma Data

NOVEMBER 18, 2020

Services for safely containing, emptying, transporting and treating human waste, and preventing pits and septic tanks from contaminating groundwater and open drains are needed, but without regulation, investments will not prioritize public health outcomes.

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The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. Shah previously served as Chief Executive Officer and a member of the board of directors of BioMotiv, an accelerator company aligned with the Harrington Project for Discovery & Development, a U.S.

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Pharmacy Checkers

NOVEMBER 21, 2019

So, without further ado, a moment of praise amongst the criticism: Despite its inability to please everyone, the FDA protects, lengthens, and improves the quality of hundreds of millions of lives through its work regulating the development, creation and distribution of medical products. The medications that we obtain in the U.S.,

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Generic Drugs Manufacturing Drugs Regulation 68