Blog

Challenges Implementing a Dark Factory in Biotechnology Manufacturing

December 11, 2023 || David Shenberger
 
The concept of a “dark factory” conjures images of secrecy and clandestine operations, but in the world of biotechnology manufacturing, it represents an innovative approach to production that promises increased efficiency, quality, and safety. A dark factory is an automated facility that minimizes human intervention, and the operations are primarily…

CAI: Evolving Past Commissioning  

December 7, 2023 || David Shenberger
 
In the dynamic world of life sciences, companies that embrace change and adapt to changing market needs are the ones that thrive. Our journey began in 1996 with a singular purpose: to change how the life sciences industry delivers facilities through robust commissioning. As we have grown and gained valuable…

Emerging Therapeutics and Personalized Medicine 

December 6, 2023 || Robert Ossig
 
A Personalized Medicines Overview  Personalized medicine, also known as precision medicine, represents a paradigm shift in healthcare, emphasizing the customization of medical treatments to individual characteristics and challenging the existing pharmaceutical manufacturing paradigm. Within this evolving field, various categories of personalized medicines have emerged, each aiming to optimize therapeutic outcomes…

Unlock the True Potential of Project Management: Power Skills Edition

December 6, 2023 || Patrick Hayes, Ph.D.
 
Introducing the Game-Changing Power Skills for Project Managers In today’s fast-paced and ever-changing world of project management, technical expertise alone is no longer enough. The true difference-maker lies in harnessing Power Skills – the secret sauce that propels project managers to new heights of success! The Evolution of Soft Skills:…

Reflecting Again on GMP Requirements for Marketing Authorization Holder

November 27, 2023 || Geraldine Carr-Mulry
 
In July 2021, the European Medicines Agency (EMA) published their reflection paper entitled “Good Manufacturing Practice (GMP ) and the Marketing Authorisation Holder (MAH)”. This paper, updated in January 2022, serves as an important guideline for MAH to understand their GMP responsibilities, especially in cases where they may not be…

State of Validation

November 27, 2023 || Jonathon Thompson, Director - Product Management
 
CAI, Kneat Solutions, and others have partnered again in 2023 to conduct the annual State of Validation survey.  The survey targets current professionals in a validation, quality, or compliance function in industries governed by Data Integrity or ICH, FDA, and EU GMP Guidelines. This year’s survey results concluded that the…

Compliance: Framing Success Utilizing PIC/S and EU GMP

November 21, 2023 || LeAnna Pearson
 
Introduction PIC/S was founded in 1995 as an extension of PIC  (Pharmaceutical Inspection Convention).  They are a non-binding cooperative arrangement between 56 different Regulatory Authorities.  Just seeing the number 56 does not have the same impact as seeing the map below and understanding the true global reach of PIC/S.  Their…

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

November 20, 2023 || Rosario Hughes-Kielty
 
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 Risk Management (QRM) principles have emerged as a key strategy in achieving this goal. QRM details a comprehensive evaluation of risks associated with both patient…

Solving Drug Shortages With AI

November 10, 2023 || Nick Armstrong
 
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, and supply chain optimization. However, as we unlock the potential of AI, we acknowledge and tackle concerns like data quality, fairness, and regulatory compliance for responsible implementation. Join us in revolutionizing drug manufacturing and ensuring reliable access to essential medications through the transformative power of AI.