Pharmaceutical Technology

MARCH 8, 2023

The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products. Its focus areas include human systems, precision diagnostics, data sciences, next-generation biomanufacturing, and genomic medicines. Topic sponsors are not involved in the creation of editorial content.

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Communication FDA 97

ISPE

OCTOBER 28, 2022

Communities of Practice Profiles: Shaping the Future of the Combination Products Industry. Communities of Practice Profiles: Shaping the Future of the Combination Products Industry. Combination Products is one of ISPE’s newest Communities of Practice (CoPs). Combination Products Consulting Services LLC. Trudy Patterson.

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FDA 52

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. The company will also receive net sales milestones and royalties on future products.

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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. This is one of the most critical success factors for biotech companies and their products.

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Documentation FDA 98

Pharmaceutical Technology

AUGUST 17, 2022

The alliance will merge the cell and media products and process development services of RoosterBio with the worldwide cell and gene therapy manufacturing expertise of AGC. . To create strong and scalable processes for hMSC and exosome therapies, RoosterBio will leverage its broad-ranging cell and media product portfolio.

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Vaccines 52

Hospital Pharmacy Europe

AUGUST 17, 2023

In the last decade, immunotherapies that treat cancers using the patient’s immune system to recognise, attack and kill malignant cells have reached the market. The engineered cells are expanded in a dedicated production facility and then administered via infusion to the patient. The guidance is divided into two sections.

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Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

ISPE

FEBRUARY 7, 2023

The two-day conference on 31 January–1 February featured a range of sessions on topics including biomanufacturing, cell and gene therapy, digital transformation and Pharma 4.0™, Hartman noted the importance of attendees’ work in bringing pharmaceuticals to patients. ™, emerging technologies, and facility design and construction.

Vaccines 88

Vaccines Dosage Hospitals 88

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.

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Method Validation Documentation Packaging Compounding 52

ISPE

NOVEMBER 23, 2022

Development of the Regulatory and Quality track was led by Ciby Abraham, Senior Director and Group Manager, Project and Product Leadership, AstraZeneca who is a member of the RQHC North America Regional Group; and Connie Langer, CMC-Global Regulatory, Pfizer, who is a member of the PQLI Committee’s Q12 Implementation team.

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FDA Documentation 52

Pharmaceutical Technology

FEBRUARY 23, 2023

The company will also receive tiered royalties on the worldwide net sales of products developed from the collaboration. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Topic sponsors are not involved in the creation of editorial content.

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Communication 59

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

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?

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication Patient Care 52

ISPE

NOVEMBER 2, 2022

Executive Director, Computer Systems Quality & Data Integrity. He thanked the outgoing Board members for their contributions: Heather Bennett-Kelley, Project Manager/Engineer, ACCO Systems; Chris Chen, CEO, WuXi Biologics Co. Project Manager/ Engineer. ACCO Engineered Systems. Nephron Pharmaceuticals.

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Documentation Compounding Communication FDA 52

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

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

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

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

OCTOBER 28, 2022

This artificial intelligence (AI) retrofit project was a unique approach to implementing AI technology in a pharmaceutical environment within three months. Visual inspection is an essential step in parenteral drug production, as it ensures the safety of the drug product in its container. Christian Stirnimann. Julien Janda.

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Labelling Pharmaceutical Companies Pharmaceutical Companies 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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FDA Insurance Chemotherapy Documentation 98

Viseven

JANUARY 13, 2023

Evaluation of drug efficiency on a dedicated market is a complex process that requires HEOR experts to measure multiple indicators to understand the actual market value of the product. Without such an assessment, it would be too risky to launch new products into development or even enter a new market. What is HEOR Data?

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Pharmaceutical Companies Pharmaceutical Companies Dosage Documentation 40

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.

Immunization 52

Immunization 52

ISPE

FEBRUARY 21, 2023

ISPE’s Women in Pharma initiative is committed to diversifying the pharmaceutical industry, paving the way for a more inclusive work culture. Women in Pharma aspires to create a pharmaceutical industry that is equitable, inclusive, free of biases and stereotypes, where diversity of thought thrives. Women in Pharma

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Insurance 52

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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Hospitals Vaccines Pharmaceutical Companies Pharmaceutical Companies 52

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

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

JULY 19, 2023

has taken on significantly increasing momentum in the pharmaceutical industry. ™ is now probably the most important industrial approach or pharma manufacturing, particularly for sterile and aseptic products. ™ opens new opportunities for quality, safety, productivity, and patient benefit. The concept of Industry 4.0

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Documentation FDA Labelling Communication 98

ISPE

JULY 10, 2023

But can we imagine applying a tool like ChatGPT in a safety-critical, product-related environment? 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.

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Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

OCTOBER 2, 2023

Attendees can plan meetings, bookmark interesting exhibitions and products, and receive personalised recommendations from AI regarding products, exhibitions and relevant content sessions. Aser Alonso, Vice President engineering & transformation, GE Healthcare, starts us off with a keynote address for drug manufacturing.

Packaging 102

Packaging 102

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. His facility gained regulatory approval and supplied the first chimeric antigen receptor T cells (CAR-T) product to young patients with leukemia. FBRI at Kobe.He

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Documentation Compounding Hospitals Immunization 98

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. Clinical trials are a key topic for these interactions. As a result of this progression, our industry developed the notion of patient-centricity.

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Immunization Pharmaceutical Companies Pharmaceutical Companies Hospitals 40

European Pharmaceutical Review

DECEMBER 21, 2022

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Organic compounds are arguably the foundation of the pharmaceutical industry.

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Compounding Pharmaceutical Companies Pharmaceutical Companies Packaging 82

ISPE

SEPTEMBER 11, 2023

In comparison to traditional large-scale manufacturing operations, decentralized modes of manufacturing can be more agile, more transportable, and tailored for specific modalities or production processes. 10 Similarly, POC manufacturing describes production at or near the location of the patient.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

OCTOBER 26, 2022

These technologically advanced systems have enabled substantially smaller platform and factory footprints that, in turn, have fueled an uptick in the design and construction of transportable single-unit operations platforms and multi-unit-operations facilities. Principal Engineer. Deputy Director, Office of Pharmaceutical Quality.

FDA 52

FDA 52

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.

Communication 52

Communication 52

PharmaShots

FEBRUARY 27, 2023

The sole purpose of the conference was to highlight the need to develop focus of the Indian pharma industry from majorly developing generics to marking its presence for innovation for the development of new products. Both days were highly productive and enlightening experiences full of energy and enthusiasm.

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Packaging Hospitals FDA Pharmaceutical Companies 40

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.

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Communication 52