Validation, Commissioning & Design White Papers & Case Studies

1. Frontage Takes The First Step In Creating Their Intelligent Laboratory 3/15/2024

   Learn how the implementation of a lab management system has enabled Frontage to accelerate its operations and initiate its journey toward establishing a truly intelligent laboratory.

2. Standardizing Content Management Across The Life Sciences Industry 3/13/2024

   Explore a quality reference model that aims to foster further standardization within the life sciences industry, and discover the advantages of leveraging the standardized best practices within.

3. Five Essentials For Accurate Oligonucleotide Chemistry 3/4/2024

   Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.

4. Streamlining Change Control For CDMOs 2/26/2024

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

5. 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.

6. Optimizing Process Loads For VHP Decontamination 2/20/2024

   Explore how CAI helped a company rescue a failing CQV project and create more efficient Vaporized Hydrogen Peroxide Material Air Lock (VHP MAL) Loads to enhance operational efficiency.

7. First-Pass Yield 1/22/2024

   Learn how a life sciences manufacturer generated a contextualized data set that eliminated the manual effort required to curate production data and improved their process in real time.

8. Advancing Compliance And Digital Strategy To Align With Pharma 4.0 11/21/2023

   AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.

9. Reliability Assessments And Benchmarking In Life Sciences 11/7/2023

   Gain insight into how a prominent medical device manufacturer observed a significant improvement in its plant-wide OSHA recordable rate and cost of goods savings of over $100,000/year in just one year.

10. The Role Of The Technical Transfer Executive Sponsor 10/30/2023

    Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.