Roots Analysis

JANUARY 27, 2025

It is worth mentioning that the past few decades have witnessed several advances in this domain, particularly in the cell therapy manufacturing process. Steps Involved in Cell Therapy Manufacturing Process Manufacturing biologics and cell therapies is considerably complex when compared to small molecule drugs.

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BioPharma Reporter

OCTOBER 6, 2021

A probe has identified 'human errorâ at the Spanish contract development and manufacturing organization, Rovi, as the reason for the presence of metal contaminants in Moderna COVID-19 vaccine doses, leading to Japanese authorities withdrawing 1.6 million doses of the shot in August.

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Pharmaceutical Technology

DECEMBER 6, 2022

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. HPAPIs may now represent more than 30% of the drug development pipeline. Within that figure, GlobalData estimates that around 60% of pipeline HPAPIs are developed to target oncology. Free Whitepaper.

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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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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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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. Partnering with containment experts.

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pharmaphorum

FEBRUARY 15, 2022

It found that the highest contamination levels were in in sub-Saharan Africa, south Asia, and South America, typically in areas of low- to middle-income countries that have poor wastewater management, rubbish dumping along river banks, and pharmaceutical manufacturing plants.

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Contamination Manufacturing Scientist Research 105

pharmaphorum

NOVEMBER 6, 2022

Eli Lilly plans for a new biopharmaceutical manufacturing facility in Ireland that will be used to produce active ingredients for its biologic medicines, including its new Alzheimer’s candidate donanemab, has been blocked by a planning objection.

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pharmaphorum

NOVEMBER 24, 2022

Now, this service-centred model is delivering advantages in the pharmaceutical industry, with costly manufacturing facilities and processes becoming widely available on an on-demand basis. million to deliver – as well as demanding specialist skills to maintain to industry standards – their widespread development has been slow.

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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. This suggests a move towards high-value specialised manufacturing. What is driving the surge in demand for APIs?

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Pharmaceutical Technology

DECEMBER 20, 2022

From partnerships to open-source technology and data transparency, the culture behind therapeutic development and delivery is shifting towards one that embraces teamwork. Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety.

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pharmaphorum

OCTOBER 14, 2022

The Digital Health in a Circular Economy (DiCE) group was formed earlier this year with the aim of developing ways to “design, collect, directly reuse, refurbish, remanufacture, and recycle digital health devices.” Great to have you on board @ForumWeee , we look forward to the next four years of collaboration!

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Roots Analysis

APRIL 15, 2024

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. Notable examples of fill finish manufacturing companies equipped with SA25 aseptic filling workstation include ( in alphabetical order ) Emergent Bioservices, PCI Pharma Services, Singota Solutions and WuXi Biologics.

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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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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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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. Best practices for ensuring API quality control One of the biggest factors in efficient API manufacturing resulting in a safe product is the control process.

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XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Each BioNTainer is a clean room equipped with state-of-the-art manufacturing solutions.

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Pharmaceutical Technology

JUNE 14, 2023

Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination. GlobalData’s Contract Small Molecule API Manufacturing Industry by the Numbers (2021) analyzed 2,787 small molecule API contract manufacturing facilities.

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pharmaphorum

MAY 5, 2022

Assuring end-patient safety through holistic contamination control. Dissect the framework of a robust Global Contamination Control Program and how to approach implementing a holistic CCS. Workshop Leaders: Ziva Abraham, President, Microrite and Morgan Polen, SME Cleanroom Contamination Control, Microrite.

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Contamination Scientist Regulation Manufacturing 52

pharmaphorum

FEBRUARY 3, 2022

Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches. 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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Roots Analysis

JANUARY 12, 2023

The focus of stakeholders has now shifted to optimizing the cell therapies manufacturing process. For the success of cell-based therapies , an effective manufacturing platform and a robust supply chain model is imperative. The key steps involved in the supply chain of cell therapies manufacturing are presented below.

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Pharma Times

DECEMBER 15, 2023

The combined system works to detect and eliminate airborne pathogens A new air-filtering system developed by the University of Glasgow and Pinpoint Medical aims to detect and eliminate airborne pathogens to combat the spread of infections in hospitals.

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Contamination Engineer Research Manufacturing 84

Roots Analysis

SEPTEMBER 20, 2023

The focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. It is worth noting that manufacturing process biologics and cell therapies is considerably complex when compared to small molecule drugs. The key steps involved in the supply chain of cell therapy manufacturing are presented below.

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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. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments.

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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. However, they are not always a first choice. When launching a new vaccine, vials tend to be chosen.

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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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Pharmaceutical Technology

DECEMBER 13, 2022

The development of a robust drying system for lyophilisation requires four key components: vacuum pumps, pressure gauges, mass spectrometers, and leak detectors. The importance of leak detection in the development of a robust drying system cannot be underestimated. Most of the moisture is removed during the primary drying stage.

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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. ” Laser marking solution company Datalase has developed a system where an inactive compound can be added to the tablet formulation.

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pharmaphorum

JUNE 8, 2022

Driving a Holistic Approach to Assurance of Product Sterility through Aseptic Manufacturing following QRM Principles. 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 This event is CPD Accredited.

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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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Manufacturing Production Development Drugs 59

XTalks

JUNE 14, 2022

Researchers at the Karolinska Institutet in Sweden developed a new nano-sensor for detecting pesticides on produce in a matter of minutes. To overcome this, we developed inexpensive and reproducible nano-sensors that could be used to monitor traces of fruit pesticides at, for example, the store.” .

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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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FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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FDA Law Blog

JULY 29, 2024

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry is intended to be a roadmap that first describes the change notification process outlined in 21 C.F.R. Part 601 delineates those changes as being either major, moderate, or minor.

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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.

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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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