Pharmaceutical Technology

APRIL 20, 2023

CircAde is said to be the most advanced therapeutic concept, and leverages the company’s experience in oncolytic viruses to use engineered adenoviruses to deliver circRNA to cancer cells. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Vaccines 96

Pharmaceutical Technology

MAY 3, 2023

BrightPath Biotherapeutics CEO Kenichi Nagai stated: “This collaboration with Artisan provides us with the potential to create highly engineered allogeneic iNKT cellular therapy programmes for a range of indications, including solid tumours. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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ISPE

SEPTEMBER 2, 2022

Producing pharmaceutical waters requires carefully designed and continuously monitored processes and equipment. Topics covered include: The preparation of pharmaceutical waters. Industry trends for pharmaceutical waters. Ensuring pharmaceutical water compliance in a PAT environment. Pharmacopeia overview.

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Communication 52

ISPE

MARCH 1, 2023

This guide to pharmaceutical waters production covers vital topics, including water purification technologies and system capabilities, global pharmacopeia regulations, the latest technologies and most importantly the four critical compendial measurements to implement for real-time compliance. Leave this field blank

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Communication 52

ISPE

JULY 10, 2023

ChatGPT : “Yes, ChatGPT can be useful in regulated areas of the pharmaceutical industry, such as providing information on drug products, their uses, dos-ages, side effects, and interactions with other medications. However, it does not provide further information on how it could be applied.

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Pharmaceutical Technology

FEBRUARY 23, 2023

Moderna Genomics general manager and chief scientific officer Eric Huang said: “Through our collaboration with Life Edit, we hope to harness the power of gene editing technologies as part of our broader research and development engine, helping to advance our mission and deliver on the promise of mRNA.”

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Communication 59

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. The continued use of paper validation in a Pharma 4.0

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Documentation FDA 98

ISPE

OCTOBER 28, 2022

Given terminology differences across jurisdictions, these products are sometimes more broadly referred to as ‘combined use systems.’. Pharmaceutical Engineering® recently spoke with Neadle about the Communities of Practice and issues related to the importance of combination products in the industry. Neadle, FAAO, FBCLA.

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FDA 52

ISPE

MARCH 28, 2023

With multiple geopolitical and pandemic related challenges in recent years, having a robust supply chain has increasingly become a strategic advantage for the pharmaceutical industry. The pharmaceutical supply chain runs through the entire process of new drugs from innovation to clinical to approval.

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Adverse Reactions Packaging Communication Labelling 52

Viseven

MAY 15, 2023

Pharmaceutical detailing is the most time-tested marketing format in the medical content world. Old-timer sales reps should remember how pharmaceutical companies reckoned face-to-face (F2F) visits with doctors as the most effective approach to achieving their sales targets. What is Pharmaceutical Detailing?

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Pharmaceutical Companies Pharmaceutical Companies Communication Patient Care 52

ISPE

NOVEMBER 23, 2022

ISPE’s regulatory volunteer groups are charged with bringing visibility and solutions to major challenges faced by the industry with regard to regulatory/quality matters, and facilitating the flow of information between ISPE members and global Health Authorities. A presentation on ISPE’s Pharma 4.0®

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ISPE

APRIL 19, 2023

Who oversees the different activities such as construction, commissioning, qualification and validation, equipment manufacturing, IT systems, and other technical aspects of the project? What about the engineers? Perform an Impact Systems Analysis. These can include: Who manages the budget? The analysts? The suppliers?

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Documentation Communication 52

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Published June 2008.

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ISPE

MARCH 28, 2023

2022 ISPE China Pharmaceutical Supply Chain Summit Trudy Patterson Tue, 03/28/2023 - 09:24 iSpeak Blog iSpeak 2022 ISPE China Pharmaceutical Supply Chain Summit 28 March 2023 On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit.

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Adverse Reactions Packaging Communication Labelling 52

ISPE

MARCH 6, 2023

Sustainability Definitions for the Pharmaceutical Industry Trudy Patterson Mon, 03/06/2023 - 10:26 Features March / April 2023 Sustainability Definitions for the Pharmaceutical Industry William G. Green Manufacturing for the Pharmaceutical Industry.” while meeting patient needs as a primary goal. 1 European Commission.

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Communication Patient Care 52

ISPE

OCTOBER 1, 2022

Cost of failure has been a consistent topic in bioprocessing for decades, yet the industry still has significant challenges with manufacturing robustness. For more information or to unsubscribe, review our Privacy Policy or contact us at ask@ispe.org. 1 October 2022. Enter other company type. Leave this field blank.

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Communication 52

ISPE

SEPTEMBER 11, 2023

The COVID-19 pandemic highlighted the need for responsive and agile manufacturing systems that can reliably perform and meet supply chain demands in a rapidly changing environment. 6 MM describes a platform in which unit operations and/or manufacturing activities are conducted in interchangeable components or modules.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 23, 2023

As the momentum grows in the rollout of various digital tools to aid verification and validation in the pharmaceutical space there are many questions in relation to the correct application of the True Copy process to digital evidence within protocols in a paperless validation system.

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Documentation FDA 98

ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. However, some of the products manufactured in a topical drug facility can be difficult to clean. Lopolito Steven M.

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Method Validation Documentation Packaging Compounding 52

ISPE

MARCH 15, 2023

Whitford Emily Heffernan, PE Aoife Kelly 1 March 2023 Many emerging tools and technologies support the environmental sustainability of the pharmaceutical industry. In facility design, solutions are derived through science-based analyses of environmental impacts from the materials, processes, services, and architecture. 7 An integrative (vs.

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Packaging Labelling Health Compliance Process Improvement 52

pharmaphorum

OCTOBER 12, 2020

Over the past few years, 3D Cell Culture has gained momentum within the pharmaceutical industry due to the benefits that this model offers for in vitro applications patient-derived tissues, drug discovery, predictivity and validation, and safety and toxicity. Rhiannon David, Scientific Lead Microphysiological Systems, AstraZeneca.

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Immunization 52

ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. In an attempt to address these challenges, in 2019 the ICH endorsed ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (and Annexes).

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Documentation FDA Communication Packaging 52

ISPE

NOVEMBER 1, 2022

Zipp spoke next to welcome attendees, who she encouraged to make the most of the meeting through sessions and meeting with colleagues, noting that many key topics are being covered. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality. Quality, Defined.

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Viseven

OCTOBER 26, 2022

The pharmaceutical industry still faces significant challenges and is looking for innovative solutions. Below are five of the most significant pharmaceutical industry problems. . Therefore, to reduce the challenges of their pharmaceutical supply chain, they changed their strategy and made the most use of the resources available.

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ISPE

MARCH 7, 2023

Melton, PhD 1 March 2023 The imperative for global action to tackle climate change is clear and the pharmaceutical industry has a key role to play. 1 , 2 The effect to the pharmaceutical industry spans its end-to-end activities, including the residual impact of used and unused medicines on the environment.

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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.

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FDA Immunization 59

pharmaphorum

OCTOBER 2, 2020

New research shows that the COVID-19 pandemic is encouraging people to take their health into their own hands, and experts say this trend towards self-care could be a significant boon for healthcare systems – one the pharma industry should be encouraging. Self-care will even up resources and give a better shape to our healthcare system.”.

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Communication 110

ISPE

NOVEMBER 30, 2022

Moreover, prescriptive analytics enable the user to understand how a piece of equipment will fail, providing information on the most significant contributing factors. Figure 1 shows where PPM fits relative to system performance and quality assessment in an APM strategy. A recent example 5. Register Now.

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Pharmaceutical Companies Pharmaceutical Companies 52

Viseven

JANUARY 13, 2023

So what do exactly HEOR experts do for the pharmaceutical companies and what HEOR-collected data is used for? HEOR collects all reports about health outcomes from patients and physicians and later provides detailed analytics to healthcare providers, clinical outcomes research institutions or pharmaceutical companies. What is HEOR Data?

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Pharmaceutical Companies Pharmaceutical Companies Dosage Documentation 40

ISPE

NOVEMBER 10, 2022

Cell therapy involves modifying the human immune system by introducing cancer-specific T cells or regenerating damaged tissue by transplanting stem cells. Pharmaceutical Engineering® recently spoke with Kawamata about his work. He was appointed as a Senior Researcher at the Institute of Biomedical Research and Innovation at the?FBRI

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ISPE

OCTOBER 27, 2022

Digital health is a broadly defined topic that encompasses the application of digital technologies in health care, living, and society to help deliver or provide access to health care products and services. An EHR is a subset of health information technology and consists of an individual patient record contained within an EHR system.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Digital health is a broadly defined topic that encompasses the application of digital technologies in health care, living, and society to help deliver or provide access to health care products and services. An EHR is a subset of health information technology and consists of an individual patient record contained within an EHR system.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

AUGUST 30, 2022

The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines contain information regarding regulatory requirements for raw materials.

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Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 12, 2022

Director, Office of Pharmaceutical Quality Operations. If health information arises from donor information, there are also risk-reducing actions that can be considered as alternative to recalls. I'd like to concur that data integrity issues and poor data governance can be found in any sector of pharmaceutical manufacturing.

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FDA Documentation Communication 52

PharmaShots

MARCH 6, 2023

Traditionally patients were viewed by pharmaceutical companies as simply users of our products, nowadays they are considered partners working towards a collective goal. In addition, the user can extract the eligibility criteria and other relevant clinical, safety, and regulatory information.

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Immunization Pharmaceutical Companies Pharmaceutical Companies Hospitals 40

European Pharmaceutical Review

OCTOBER 2, 2023

Once the event is finished, you can export the contact information of the connections you made for easy follow-up calls. It will cover topics such as manufacturing challenges for autologous cell therapies and cell therapy roadmaps to address challenges and drive speed-to-market. CEO of the Year 11. Start-Up Initiative 12.

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Packaging 102

ISPE

OCTOBER 28, 2022

The conference focused on the ongoing development and growth in these technologies, and featured speakers on a broad range of topics, including advanced manufacturing and how lessons learned from COVID-19 vaccine development can apply to biologics development. Highlights of the discussion follow. Collaboration.

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