European Pharmaceutical Review

MARCH 28, 2023

Eli Lilly and Company will double its investment to nearly $1 billion at its new biologics drug manufacturing facility, in Raheen, Limerick, stated Ireland’s Industrial Development Agency (IDA). Eli Lilly claimed that based on current design estimates, Limerick is estimated to produce 3.17

Pharmaceutical Companies 72

Pharmaceutical Companies Pharmaceutical Companies 72

European Pharmaceutical Review

MARCH 6, 2023

The Oxfordshire campus comprises of Europe’s largest collection of open access, publicly funded scientific facilities. ” Post-construction, the facility “will harness mRNA science that aims to develop and deliver innovative vaccines to the UK public that address emerging threats from respiratory viruses.”

Vaccines 83

Vaccines FDA 83

ISPE

FEBRUARY 17, 2023

Key among these included a presentation by the director of FDA’s CBER on cell and gene therapy manufacturing and a range of considerations behind new facility planning from a Janssen Pharmaceuticals executive whose company has been paving the road ahead with its facilities. The facility does a lot of multivariate analysis.

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FDA Vaccines 98

ISPE

JUNE 23, 2023

Presentations will discuss harmonized approaches to advancements in drug development, design and equipment solutions, and project delivery strategies to ensure that quality therapeutic products are brought to market in an efficient and sustainable manner to improve patient health. and Chugai Pharma Manufacturing Co.

Pharmaceutical Companies 94

Pharmaceutical Companies Pharmaceutical Companies 94

ISPE

SEPTEMBER 29, 2023

While it is very energy-consuming to produce these therapies, Takeda paid special attention to the facility’s design to optimize the processes and to make them, and the site, as energy efficient as possible in keeping with their commitment to minimize environmental impact and progress towards future sustainability goals.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Labelling Patient Care 52

Pharma Manufacturing

MAY 26, 2022

With utility costs on the rise, many pharma manufacturers are taking a closer look at their facilities and finding that better facility design, resource management and maintenance strategies can offer sources of overlooked savings, as well as opportunities for sustainability.

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European Pharmaceutical Review

NOVEMBER 16, 2022

For young biotechs, scaling up production brings green-field challenges, while for more established pharma a shift may be required to ensure that facilities are optimised for new ways of working. Achieving commercial scale as a biotech: embracing quality by design. Embracing the spirit rather than the letter of regulations.

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Documentation Vaccines 111

pharmaphorum

SEPTEMBER 23, 2020

Sixfold Bioscience in partnership with Medicines Discovery Catapult, has been given the green light, through the award of an Innovate UK Smart Grant to test a pioneering system designed to deliver drugs directly to cancerous cells, without impacting the healthy cells around it.

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European Pharmaceutical Review

FEBRUARY 22, 2023

This means practices are designed to work together to achieve proactive contamination control and are evaluated for their collective effectiveness. Dr Madina Karimova, Quality Assurance Manager at Sanofi shared her opinion on PDA’s TR 90 report, highlighting parts she found valuable.

Documentation 88

Documentation 88

ISPE

JUNE 15, 2023

Manufacturing Execution Systems & Electronic Production Records Management: A Building Block for Pharma 4.0™ ™ & Your Organisation’s Digitlization Journey Trudy Patterson Thu, 06/15/2023 - 09:27 iSpeak Blog iSpeak Manufacturing Execution Systems & Electronic Production Records Management: A Building Block for Pharma 4.0™ ™ Pharma 4.0™

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European Pharmaceutical Review

MARCH 7, 2024

Last month, construction began on Europe’s first industrial-scale facility dedicated to the production of lead-212 based radioligand therapies. Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Immunization FDA 52

The 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. 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 72

pharmaphorum

SEPTEMBER 2, 2020

The 3rd Lab Asset & Facility Management in Pharma will return this Winter as your ONLY industry led meeting focusing on R&D asset and FM, enabling you to regain control of your assets , optimize your space and benchmark best practices to stay ahead of the curve. What’s New in 2020? Streamed Content.

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ISPE

SEPTEMBER 28, 2023

All these factors and more have transformed California into a leading destination for life sciences facilities, making the state as well known for medical breakthroughs and biotech as it is for telecommunications and software. This method extended to reviewing the design and energy models, all contributing to a more thorough pricing strategy.

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Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 98

Pharmaceutical Technology

APRIL 25, 2023

The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US. The audit was focused on the quality management systems and platform AAV manufacturing process of the facility. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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European Pharmaceutical Review

MARCH 5, 2024

He asserted that the biotech plans to handle this by “operating our own manufacturing facilities for both small molecule medicines and large molecule biologics to support ongoing clinical research and global commercialisation of our internally developed medicines.”

Medical Schools 92

Medical Schools 92

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.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Packaging Labelling 40

European Pharmaceutical Review

AUGUST 29, 2022

During the design process, spent media samples can be analysed for amino acids and nutrients to fine-tune the media based on the cells’ needs” However, some groups want to use their own current media as a starting point for further optimisation. Discussions with the client enables the right service to be selected for their needs.

Process Improvement 88

Process Improvement 88

pharmaphorum

AUGUST 1, 2022

This article follows part one of our two-part series, where we discussed how Philips designs innovation and digital health solutions for areas of India’s healthcare system where options are sparse. . In contrast to India, there’s not only a lack of healthcare facilities, but the facilities are not offering the services needed.

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Packaging Insurance Communication Hospitals 76

European Pharmaceutical Review

AUGUST 2, 2023

The authors explained that an innovative analytical strategy is essential for building resilience and managing risks in manufacturing quality as well as for gaining competitiveness in the industry. Therefore, designing an instrument that reduces sample and reagent consumption to a few microliters is more advantageous, Wu et al.

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ISPE

SEPTEMBER 21, 2023

This track will delve into five important topics where you will hear from speakers who will help answer your questions and provide you with the necessary information to make confident decisions regarding any updated changes to your facility, equipment, procedures, and documents.

Documentation 98

Documentation FDA 98

pharmaphorum

JULY 25, 2022

Approximately 75% of the population resides in rural tier two and tier three cities and villages in India, and less than 20% of the country’s medical facilities are in those regions, creating an enormous imbalance and leading to immense inaccessibility for millions of rural residents. Not so much in tier two and tier three.”.

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Communication Hospitals 120

European Pharmaceutical Review

NOVEMBER 9, 2023

Through process optimisation and investment in such technologies, MSD’s Dublin Biotech site has managed to “triple output annually,” site head Liam Dunne explains. When it comes to biologics, scaling up production to ensure global supply is a remarkable process that embodies Industry 4.0

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indispensable health

SEPTEMBER 7, 2021

Department of Justice and the Drug Enforcement Administration (DEA) Regulate Controlled Substances Within Multiple Healthcare Settings These regulations require every healthcare setting (acute care facility, pharmacy, outpatient surgery center, long-term care facility, distributor, manufacturer, etc.) Pharmacy Management Services.

Controlled Substances 52

Controlled Substances Long-Term Care Facilities Dosage 52

ISPE

SEPTEMBER 15, 2022

Special focus of the completely revised Annex 1 is the application of the Quality Risk Management methodology to manufacturing, especially to the Contamination Control Strategy, the technical environment for aseptic filling, the technical conditions for clean utilities, especially for the production and storage distribution of Water for Injection.

Documentation 97

Documentation FDA 97

ISPE

FEBRUARY 7, 2023

™, emerging technologies, and facility design and construction. For the latter two, some medications can be combined for cardiovascular treatment with less frequent dosages, which helps ensure older patients who may struggle more with maintaining a drug taking schedule receive the medications needed to manage the condition.

Vaccines 88

Vaccines Dosage Hospitals 88

Dr. Jamie Hardy: The Lifestyle Pharmacist

NOVEMBER 5, 2023

At Be Fab, we are committed to helping you achieve total wellness and reach your weight management goals. That’s why we have carefully curated two incredible bundles that are designed to support your overall well-being and help you on your weight management journey. Ready to get serious about your health journey?

Immunization 52

Immunization FDA 52

ISPE

OCTOBER 25, 2022

She also worked on design and CQV projects of all sizes and provided business solutions to spearhead expansion of NNE and ADVENT. For the past 10 years, she has provided consulting services to many bio-pharma companies across the globe and grew several life-science consulting organizations while managing their business functions.

Vaccines 98

Vaccines 98

Pharmaceutical Technology

JUNE 19, 2023

A few aspects that are oftentimes overlooked include the importance of mapping all of the lanes from your depot or storage facility to the clinic, but also who will be met at the site and where. Designing a world-class gene therapy suite Cryostorage is an important feature of any advanced therapy facility.

Packaging 52

Packaging Compounding Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 24, 2023

The answer is yes…as long as they are designed with data security in mind. But a well-designed cloud application that complies with modern security standards and regulations can actually be more secure than holding data on an internal network. CSPs should design their security programs in compliance with ISO 27001.

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Communication Documentation 98

pharmaphorum

JANUARY 6, 2021

In 2018, we were preparing to build a European facility to produce individualised cell therapies for the treatment of cancer. In my experience, completing the design and build of a facility such as this, through to qualification, licence and becoming fully operational, would normally take four to five years.

Hospitals 117

Hospitals Communication 117

ISPE

SEPTEMBER 1, 2023

The answer is yes…as long as they are designed with data security in mind. 1 Important to Note: In the context of industrial processes and manufacturing, plant process management (PPM) refers to the systematic planning, implementation, and control of processes to ensure efficiency, quality, and productivity in a production environment.

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Communication Documentation 98

ISPE

MARCH 30, 2023

Greenfield facilities that have been the first to embrace the tools of Pharma 4.0 However, for many organisations and facilities, being sold the advantages of digital twins, real-time predictive analytics, advanced robotics, and artificial intelligence, can feel like hearing a distant pipe dream. Industry 4.0,

Documentation 98

Documentation 98

Pharmaceutical Technology

OCTOBER 6, 2022

According to Adam Bradbury, GlobalData PharmSource analyst “[…] evidence indicates that containment facilities are in high demand and will be increasingly so in future as the oncology pipeline and the use of cytotoxic drugs continues to grow.” Protecting product characteristics.

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Omnicell

JANUARY 10, 2023

Stephanie Gallagher, PharmD, MBA Senior Clinical Product Marketing Manager, Omnicell Despite the reality that intravenous (IV) compounding is among the highest risk areas in the continuum of acute care when it comes to the potential for possible patient harm, IV systems are often the last to be impacted by advances in pharmacy automation.

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Sterile Compounds Compounding Omnicell Hospitals 52

The Checkup by Singlecare

FEBRUARY 28, 2024

To qualify for Medicaid in Pennsylvania, residents must meet certain income, age, disability designation, citizenship status, and/or healthcare needs requirements. Included services can range from getting assistance with activities of daily living at home to receiving advanced medical care in a nursing facility.

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Packaging Documentation Hospitals Insurance 52

Board Vitals - Pharmacist

JANUARY 11, 2024

According to The Pharmacy Times , Pemberton first created the carbonated drink from coca leaves (cocaine) and kola nuts to manage his war-injury pain. Insurance providers: Consultant pharmacists advise healthcare facilities or insurance providers on patient medication use or on how to improve pharmacy services. According to the U.S.

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Retail Drug Stores Hospitals Insurance Patient Care 98