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Changing Lives with Gene Therapies Pharmaceutical Engineering

The process of bringing new drugs and products to market requires creativity, thinking outside the box, and the courage to fail numerous times before making a single discovery. This rings especially true now, as the industry faces the COVID-19 pandemic and doubts about vaccines and therapies getting to market in record time to improve human health. This article presents a deep dive into gene

Actived: 6 days ago

URL: https://ispe.org/pharmaceutical-engineering/november-december-2021/changing-lives-gene-therapies

What You Need to Know About GAMP® 5 Guide, 2nd Edition

WebISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, 2nd Edition) maintains the principles and …

Category: Health Go Health

Challenges & Opportunities in Emerging Digital Health …

WebDigital health is transforming the health care landscape through new technologies and platforms in patient care management, conducting of clinical trials, …

Category: Health Go Health

Pharmaceutical Engineering Home ISPE International Society for

Web6 March 2024. ISPE’s Regulatory Quality Harmonization Committee (RQHC) is structured with four Regional Focus Groups (RFGs): Asia-Pacific, Europe/Middle East/Africa, Latin …

Category: Health Go Health

Live Biotherapeutic Products: Moving the Microbiome to the …

WebLive biotherapeutic products (LBPs) have the potential to treat a wide range of ailments. However, these living microorganisms are difficult to produce due to evolving …

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What is GMP cGMP Good Manufacturing Practice

WebWhat is GMP? GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and …

Category: Food Go Health

Personalized Medicine: The Industry’s Future

WebThe future of true personalized medicine is the design and manufacture of one drug for one patient; 2 whether this is possible or sustainable for the pharmaceutical industry depends …

Category: Medicine Go Health

A Vision for ICH Q12: Current Experience, Future Perspectives

WebCurrent Adoption by Global Regulators. The final draft of ICH Q12 was adopted by the ICH Assembly in November 2019 (Step 4), and the guideline is now in Step 5, with regional …

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Bowtie Analysis and Barrier-Based Risk Management

WebThe bowtie enhances understanding of industry-specific scenarios and provides clear indication that the safeguards (risk-control measures) are in place and performing. It …

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Research Triangle: Building a Foundation for Pharmaceutical and

WebNorth Carolina’s Research Triangle is the largest of its kind in the US. Thanks to years of effort from industry, pharmaceutical professionals, and education institutions, …

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Engage with Health Authorities to Mitigate & Prevent Drug …

WebWhen faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and business continuity plans of drug manufacturers and …

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Building Resilient and Sustainable Pharmaceutical Supply Chains

WebThe global pharmaceutical industry has faced unprecedented challenges in recent years, with the COVID-19 pandemic serving as a wake-up call for the …

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ICH Quality Guidelines: Present Initiatives & ISPE Involvement

WebApproved Quality Guidelines. In the first decade, ICH teams worked on quality topics described in ICH Q1–Q6, working from a prioritized list (as given on the ICH website6 …

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Good Engineering Practice in Risk-Based Commissioning

WebOver the years, the roles and responsibilities of engineering and quality/validation personnel for commissioning and qualification (C&Q) activities have …

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Sustainability & the Life Sciences Industry: A Global Introduction

WebIn this issue of Pharmaceutical Engineering®, we address an array of sustainability topics. This article surveys topics that will likely have a significant global …

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Why ISPE GAMP® Supports the FDA CDRH: Case for Quality …

WebThe US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric …

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Cleaning Validation Program Maintenance in a Process Life-Cycle …

WebThe process life-cycle model, as discussed in the US FDA guidance on process validation, is a significant change in how we view validation.1 The three-stage …

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Pharmaceutical Cleanroom Design & ISO 14644-16

WebIn relation to ventilation efficiency, ISO 14644-16 specifies two types of ventilation efficiency: CRE and ACE. ACE is determined according to AN-SI/ASHRAE 129-1997, 12 which …

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Quality Risk Management (QRM) Workshop Training Course

WebQuality Risk Management Workshop (T42) Overview. Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on …

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Automating MACO Calculations in Cleaning Validation

WebThe CVLM program calculates MACO using four methods: health-based exposure limit (HBEL), therapeutic dose, toxicological, and 10-ppm approaches. Different …

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Nandita Kamdar is a Director in the Engineering & Property …

WebNandita Kamdar is a Director in the Engineering & Property Services (E&PS) Group at Johnson & Johnson in New Brunswick, NJ. She joined Johnson & Johnson in 2012.

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ISPE NJ Newsletter

Webprospective Young Professional members join us, along with a number of current YP members. This was a great networking event, at a pleasant, comfortable

Category: Health Go Health

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