Archives

Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
Blog Post

Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities

Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect...

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Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline
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Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline

To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality...

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Biotech’s Compliance Odyssey: Navigating the Revamped EU GMP Annex 1 in the Age of Innovation and Accountability
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Biotech’s Compliance Odyssey: Navigating the Revamped EU GMP Annex 1 in the Age of Innovation and Accountability

In the dynamic world of biotechnology, where innovation is moving at a rapid pace and patient safety is paramount, compliance with regulatory standards is non-negotiable....

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Solving Drug Shortages With AI
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Solving Drug Shortages With AI

Explore the positive impact of artificial intelligence (AI) on pharmaceutical manufacturing, addressing persistent drug shortages. Dive into the benefits of predictive analytics, quality control enhancements,...

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Revolutionizing Drug Manufacturing: A closer look at pending Facility Applications for GMP Inspections
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Revolutionizing Drug Manufacturing: A closer look at pending Facility Applications for GMP Inspections

COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. Whilst certain aspects of the pandemic have gone away,...

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The Pollinator-Friendly Data Centre Industry In Ireland That Is Helping To Save The Bees.
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The Pollinator-Friendly Data Centre Industry In Ireland That Is Helping To Save The Bees.

"The bee is more honoured than other animals, not because she labours, but because she labours for others." - St. John Chrysostom There appears to...

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Overcoming Commissioning Challenges to Achieve Operational Readiness
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Overcoming Commissioning Challenges to Achieve Operational Readiness

As the data center market continues to grow exponentially, 3rd party testing and commissioning becomes vital to achieving Operational Readiness on time and in budget....

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Revolutionizing Drug Development: The Role of AI in Protein Folding and its Impact on the ATMP Industry
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Revolutionizing Drug Development: The Role of AI in Protein Folding and its Impact on the ATMP Industry

Protein Folding BackgroundIn the realm of drug development, the intricacies of protein folding have long posed a significant challenge. The way a protein folds directly...

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The Knowledge Transfer Stage of Technology Transfer
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The Knowledge Transfer Stage of Technology Transfer

Knowledge Transfer: The Crucial Stage of Successful Tech Transfer Technology transfer (TT) is a pivotal process in the lifecycle of any product, ensuring the smooth...

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Achieving Operational Excellence in Pharmaceutical Manufacturing through Program Management
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Achieving Operational Excellence in Pharmaceutical Manufacturing through Program Management

In the fast-paced and highly regulated world of Biotech and Pharma manufacturing and operations, achieving Operational Excellence is paramount. It requires streamlined processes, efficient resource...

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The Power of AI Augmentation: Unraveling Insights through Human-Generated Unstructured Data
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The Power of AI Augmentation: Unraveling Insights through Human-Generated Unstructured Data

Introduction Artificial Intelligence (AI) has emerged as a game-changer, revolutionizing industries and transforming the way we live. Rather than replacing people, AI complements and augments...

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