INSIGHTS ON QUALITY ASSURANCE

• Streamlining Change Control For CDMOs

  Here, we outline a holistic approach for CDMOs to streamline the change control process, aiming to enhance quality, compliance, and time-to-market.

• Quality Management Process Improvement

  With the constant introduction of new technologies, employees are regularly overwhelmed by organizational complexity and information overload. Learn how to achieve simplicity in quality management, facilitate change, and more.

• 4 Reasons Your Startup Should Implement QMS

  Explore four reasons why your medtech startups is ready to implement quality management system and move into a new digital age.

• Are Electronic Manufacturing Logbooks Better Than Paper?

  We accept the aid of automated paperless technology in our everyday lives, so why not in life sciences manufacturing? Check out some of the benefits of eLogbook management.

• Monitoring And Determining The Cause Of Antibody Discoloration Using cIEF And EAD

  9/21/2023

  View a study which provides additional insight into the factors that govern the discoloration of protein therapeutics and the role of AGEs in color change.

• Key Pillar Of A Successful CDMO: Exceptional Regulatory Compliance

  10/18/2023

  Ensuring regulatory compliance is paramount for a CDMO to meet manufacturing standards, warrant patient safety, and maintain its reputation.

• Overcome The Hidden Complexities Of mRNA Process Development

  3/22/2023

  Explore the challenges behind the perceived simplicity of mRNA process development, as well as characterization strategies and models for predicting process outcomes at early stages.

• How To Solve Difficult Challenges Of Cell&Gene Therapy Manufacturing

  2/17/2023

  Explore how paper batch records hold back cell and gene therapy manufacturing and the digital solutions that could help improve efficiency.

• Alofisel P3 Cell Therapy Facility

  2/21/2024

  Despite various issues with a client's CQV project, CAI delivered the project on time and significantly contributed to the delivery of the first ATMP facility in Ireland.