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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Bioequivalency Production Branding Contamination 130

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

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

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

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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Containment Hormones Contamination Packaging 96

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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Manufacturing Hormones Contamination Contract Manufacturing 40

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

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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Compliance Contamination Manufacturing Production 52

XTalks

SEPTEMBER 13, 2022

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. plastic vacuum-packed packages containing ‘GROUND BEEF 85% LEAN/15% FAT’ with codes ‘EST#46841 L1 22 155’ or ‘EST#46841 L5 22 155’ on the side of the packaging.”. While most E.

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Bacteria Packaging Packaging Production 98

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

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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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. Using the contaminated mouthwash can result in “oral and, potentially, systemic infections requiring antibacterial therapy. Shane Erickson Inc.

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Contamination Vaccination Vaccine Pharmacy 52

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

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Biohazard 52

Pharmaceutical Technology

NOVEMBER 17, 2022

According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities. Flexible containment solutions for potent APIs. Partnering with containment experts.

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Containment Contamination Contract Manufacturing Production 130

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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Manufacturing Production Vaccination Vaccine 40

Camargo

NOVEMBER 29, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.

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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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Manufacturing Production Contamination Gene Therapy 40

Advarra

MARCH 31, 2023

This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

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Engineer Genetics Clinical Research Research 52

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

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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Pharmacy Containment Sales Licensing 98

The Pharma Data

FEBRUARY 18, 2022

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if: the first two digits of the code are 22 through 37; and the code on the container contains K8, SH or Z2; and the expiration date is 4-1-2022 (APR 2022) or later. and were likely exported to other countries.

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Production Bacteria Containment Cosmetics 40

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

The Pharma Data

DECEMBER 16, 2020

Cadmium is found in cigarettes and in contaminated vegetables. “Our motivation was to find a modifiable risk factor that can predispose people with COVID-19 infection to develop a severe complication and die of COVID-19,” Park added. “COVID-19 may not be a one-time event. © 2020 HealthDay.

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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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Drugs Production Marketing Contamination 52

XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Trulicity (Dulaglutide) Trulicity sales in 2022: $7.439 billion Company/Developer: Eli Lilly & Co.

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Sales Insulin FDA Approval Drugs 52

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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Contamination Containment Biobanking Packaging 40

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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Regulation Compliance Contamination Marketing 52

XTalks

NOVEMBER 7, 2022

However, Dr. Bahassi reported that the selection of CTCs using this method is often not very efficient and the CTC population is usually highly contaminated with leukocytes. During the webinar, Dr. Bahassi gave a brief schematic of how personalized, targeted assays can be developed to detect somatic mutations from cfDNA ( Figure 1 ).

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Clinical Trials Clinical Trials Trials FDA Approval 98

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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Manufacturing Gene Genome Genomics 98

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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Contamination Filler Bioavailability Production 130

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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Packaging Packaging Containment Production 40

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

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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Vaccination Vaccine Drug Delivery Systems Sales 97

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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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. These host cells alone contain over a thousand HCPs. coli, and Pichia cells.

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Production Gene Protein Vaccination 52

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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