ISPE

FEBRUARY 7, 2023

Hartman noted the importance of attendees’ work in bringing pharmaceuticals to patients. A previous presenter on issues related to the pandemic, he observed that it was good to be able to return to reflect on “where we were a year ago and where we are today.” Initiatives in the pharmaceutical industry include the NIIMBL consortium.

Vaccines 88

Vaccines Dosage Hospitals 88

European Pharmaceutical Review

DECEMBER 6, 2023

Historically, pharmaceutical manufacturers have built sufficient capacity so that they can leverage sudden surges in demand. So first you need to deploy engines that will selectively provide the data that you’re looking for. So, we’ve been having issues there. Thus, we are hiring more engineers.

Packaging 86

Packaging Vaccines 86

ISPE

SEPTEMBER 8, 2023

This article outlines ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients (APIs). This article outlines these initiatives. This article outlines these initiatives.

Documentation 91

Documentation 91

ISPE

OCTOBER 28, 2022

“Membrane-based water for injection is a state-of-the-art method that should be used whenever possible,” said Good Practice Guide (GPG) Co-lead Fritz Roeder, Global Engineering Manager, Merck Healthcare KGaA. Learn More & Purchase. Meet the ISPE Staff: Tim Postlethwaite. Meet Tim Postlethwaite, Director of Technical Communities.

Documentation 52

Documentation 52

Pharmaceutical Technology

JUNE 26, 2022

MAX can predict maintenance issues and send alerts to elevator engineers to replace components and systems before the end of the product lifecycle. It provides real-time alerts to service engineers and technicians on pre-issue repairs, making property owners more proactive with customers.

Communication 52

Communication 52

European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Despite issues of potential toxicity and biocompatibility, several polymers have advanced to clinical trial stages. Pharmaceutics. Curr Opin Biotechnol. 2022; 78:102785.

FDA 94

FDA Vaccines Immunization Compounding 94

ISPE

MARCH 8, 2023

Introducing CoP Leader Profiles: Rachel Owen Trudy Patterson Wed, 03/08/2023 - 09:46 InTouch March / April 2023 Introducing CoP Leader Profiles: Rachel Owen Marcy Sanford 1 March 2023 With this issue, Pharmaceutical Engineering ® launches a new feature in P+E: profiles of Communities of Practice (CoP) leaders.

Controlled Substances 52

Controlled Substances 52

European Pharmaceutical Review

SEPTEMBER 30, 2022

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St.

Hospitals 127

Hospitals 127

Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. The pharmaceutical freeze-drying systems market is expected to be driven by the integration of smarter technologies in lyophilisation methods such as electron microscopy, biochemistry, and advancement in surgeries.

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Documentation Packaging Vaccines 59

European Pharmaceutical Review

JANUARY 26, 2023

CAR T-cell therapy engineers a patient’s own immune cells (T-cells) to detect, target and destroy cancer cells. EC approves CAR T-Cell therapy for B-cell lymphoma The post First CAR T-cell therapy recommended on NHS appeared first on European Pharmaceutical Review. What is CAR T-cell therapy?

Chemotherapy 122

Chemotherapy Immunization 122

Pharmaceutical Technology

SEPTEMBER 16, 2022

degree rise proposed in the Paris Climate Agreement is well understood by leaders in the pharmaceutical industry. And despite the recent pandemic that forced the industry to develop and deliver treatments and vaccines all over the world, the issue of reducing emissions has remained high on industry leaders’ agendas. 1] [link]. [2]

Vaccines 52

Vaccines Labelling 52

European Pharmaceutical Review

JANUARY 27, 2023

Once implemented the manufacturing regulatory framework will apply to all point of care (POC) products manufactured in the UK, such as: Advanced therapy medicinal products (ATMPs), such as cell therapy , gene therapy and tissue engineered products 3D printed products Blood products Medicinal gasses.

Hospitals 94

Hospitals 94

pharmaphorum

NOVEMBER 11, 2020

Abid Rahman from Intouch Group tells pharmaphorum how AI-based technology is solving challenges across healthcare systems, pharmaceutical companies, and patient treatment. With AI already the key engine for a growing list of consumer devices, the trend has created exciting opportunities for pharma and healthcare. “We

Pharmaceutical Companies 139

Pharmaceutical Companies Pharmaceutical Companies Communication Hospitals 139

European Pharmaceutical Review

FEBRUARY 22, 2024

Current challenges In her presentation, she shared that within the AMR therapeutics space, especially for SME biotechs, there are “funding issues… the broken commercial market for antimicrobials, [as well as] challenges of investment in this space versus other therapeutic areas.” Public Health. 2024; 12; 12.

Compounding 52

Compounding 52

European Pharmaceutical Review

NOVEMBER 16, 2022

Engineering or redesigning facilities without due consideration of what is needed, of what may be superfluous, or of how systems and processes will be validated over time, could lead to costly remedial action and delays in getting important and premium new products to market. Embracing the spirit rather than the letter of regulations.

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Documentation Vaccines 116

ISPE

JULY 10, 2023

It offers potential safety benefits and requires a smaller facility footprint,” said Guide Co-lead Dave DiProspero, Director of Pharmaceutical Process Technology, CRB. The consensus among experienced practitioners is that the continuous approach has numerous benefits. However, there are still many challenges to widespread adoption.

Dosage 52

Dosage Pharmaceutical Companies Pharmaceutical Companies Communication 52

Pharmaceutical Technology

APRIL 5, 2023

This includes the first potential approval of a CRISPR-based gene therapy called exa-cel , which is developed by CRISPR Therapeutics and Vertex Pharmaceuticals. In an exclusive interview with Pharmaceutical Technology , Bruce Levine, PhD, talks about the past, present, and future of CAR-T therapies and what challenges lie ahead.

FDA 59

FDA Immunization 59

ISPE

NOVEMBER 2, 2022

Applying what has been learned over the last three years to update pharmaceutical companies’ approaches to development and implementation is key as the industry crafts its strategies in an increasingly digital and global environment. Geopolitical: what’s happening around the world. Sustainability. President, U.S. Business Unit and U.S.

Vaccines 98

Vaccines Pharmaceutical Companies Pharmaceutical Companies Hospitals 98

pharmaphorum

JUNE 9, 2022

Antimicrobial resistance (AMR) is an issue of global concern, killing roughly 1.2 In order to reduce the global healthcare impact of the evolving AMR situation, companies such as Micreos Pharmaceuticals are taking a novel and highly innovative approach to antibacterial drug development by developing targeted antimicrobial products.

Chemotherapy 103

Chemotherapy 103

European Pharmaceutical Review

JUNE 27, 2023

“On a steep learning curve, manufacturers of mAb therapies have dealt with issues such as immunogenicity, adverse events linked to blockade of the specific target of the mAb, such as infections from tumour necrosis factor inhibitors) and others.” There were no maternal or infant deaths and there were no reports of foetal hydrops.”

Immunization 89

Immunization 89

European Pharmaceutical Review

SEPTEMBER 28, 2023

Technology advancement Chornet reflected that the pharmaceutical industry has seen changes in the past few years, not only in vaccines manufacturing, but more broadly in the biotech sector, too. He has over 20 years of experience in manufacturing and operations within the pharmaceutical industry.

Vaccines 90

Vaccines 90

Hospital Pharmacy Europe

AUGUST 17, 2023

In CAR T-cell therapy, which is classified as an advanced therapy medicinal product, autologous T-cells are genetically engineered ex vivo to express CARs that direct the patient’s lymphocytes to kill the tumour cells. The engineered cells are expanded in a dedicated production facility and then administered via infusion to the patient.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

pharmaphorum

OCTOBER 27, 2022

The Guidance applies to all member companies of EFPIA and IFPMA, but also acts as useful guidance for all pharmaceutical companies as to how the authorities will interpret the legislative provisions to social media channels. Influences and opinion leaders may be media figures within a particular sector or experts on specific issues.

Communication 98

Communication Packaging Documentation Pharmaceutical Companies 98

European Pharmaceutical Review

AUGUST 23, 2022

1 Simply, pharmaceutical products are the most vulnerable to counterfeiting. 2 The global counterfeit pharmaceuticals trade is estimated to be worth billions annually, 3 bolstered significantly by the increased illicit online pharmacies that emerged during the COVID-19 pandemic. This allows for a cyber?physical All protein?based

Dosage 95

Dosage Packaging Pharmaceutical Companies Pharmaceutical Companies 95

ISPE

MARCH 8, 2023

ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Cultural Excellence provides a quality management framework for assessing and advancing an organization’s culture of quality. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes.

Documentation 52

Documentation Communication 52

ISPE

OCTOBER 28, 2022

Pharmaceutical Engineering® recently spoke with Neadle about the Communities of Practice and issues related to the importance of combination products in the industry. We have industry representatives spanning international pharmaceutical, biotech, and device companies, as well as consultants.

FDA 52

FDA 52

ISPE

AUGUST 1, 2023

As a distinguished member of the pharmaceutical industry, you wouldn't want to miss this exciting event. Embracing Industry Trends - Conference Tracks Discover the pulse of the pharmaceutical industry through our five concurrent tracks, designed to tackle pressing challenges and opportunities.

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ISPE

DECEMBER 1, 2022

For the fourth consecutive year, the annual ISPE Italy Affiliate Award for women in the pharmaceutical sector will be organized by the local group of ISPE Women in Pharma® (WIP). The “Graziella Molinari Women in Pharma Award” Announced for 2022 Edition at the ISPE Italy Affiliate. 1 December 2022. perspective. .

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98

ISPE

APRIL 12, 2023

Paper-Based Validation in Biotech: No Longer a Choice The complexities of biological processes like cell line development, protein expression, and capsid engineering demand extreme precision and thorough documentation for regulatory bodies. Pharmaceutical Engineering. The continued use of paper validation in a Pharma 4.0

Documentation 98

Documentation FDA 98

European Pharmaceutical Review

JUNE 22, 2023

Through the certification, we are verifying whether environmental and waste controls are in place throughout the antibiotic supply chain production and chain of custody, from where the drug is manufactured from the active pharmaceutical ingredient (API) stage towards finished drug production. Internet] UNEP. cited 2023Jun].

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86

European Pharmaceutical Review

AUGUST 24, 2022

The fundamental basis of engineering ADCs is to conjugate specific antibodies, using a chemical linker, to a potent anti-cancer drug – often referred to as a cytotoxic payload in the context of ADCs. Prior to his role at Tubulis, Jonas gained 10 years of field experience, deepening his knowledge of biotechnology and antibody engineering.

Compounding 90

Compounding Pharmaceutical Companies Pharmaceutical Companies 90

European Pharmaceutical Review

OCTOBER 6, 2022

Bacterial identification systems are analytical techniques and technology used in microbiology, biotechnology, genetic engineering and medical industries. The report presented common methodical issues that result in inaccurate findings during microbial identification. billion by 2032 appeared first on European Pharmaceutical Review.

Compounding 93

Compounding 93

European Pharmaceutical Review

OCTOBER 20, 2022

In particular, purified water and WFI are critical when producing sterile pharmaceutical drug products. In fact, process analytical technology (PAT) probes face many of the same issues with representativeness as grab sampling. This naturally sets different requirements for the two types of water. This is only true if there is time?dependent

Pharmaceutical Companies 94

Pharmaceutical Companies Pharmaceutical Companies FDA 94

ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality. Quality, Defined.

FDA 98

FDA Insurance Chemotherapy Documentation 98

ISPE

SEPTEMBER 22, 2022

The need for accelerated project delivery in pharmaceutical drug development and manufacturing has become a common practice. VTU Engineering. Project Manager & Pharmaceutical Consultant. In response to Covid-19, the global drug development community has moved faster and further than ever before. Bart Briers. Joris Buffels.

Vaccines 52

Vaccines 52

Pharmaceutical Technology

NOVEMBER 29, 2022

The treatment, sold under the brand name Spravato by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson , is also indicated for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal thoughts. Still, Funding is not the only issue. Impact of long-term use unclear.

Pharmaceutical Companies 110

Pharmaceutical Companies Pharmaceutical Companies Labelling FDA 110

ISPE

SEPTEMBER 28, 2023

It's no wonder that global pharmaceutical companies are increasingly sourcing innovation through alliances and partnerships with their peers in California. This issue was resolved using communication methods and reprogramming strategies from the TI and core and shell sides. Management WoF

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Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 98