Industry Insights

1. Key Considerations For Cryogenic Preservation And T Cell Viability 7/31/2020

   Illustrating how mammalian cells change when frozen, we offer cryopreservation strategies and identify temperatures at which it's safe to stop controlled cooling and transfer drug product to cryogenic storage.

2. Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs 11/20/2023

   Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

3. Why Pharma Risk Assessments Should Include 'Working Together Alone' 4/16/2025

   When understood and managed properly, subjectivity becomes a source of creativity. It reveals hidden hazards and unlocks more effective risk controls.

4. How To Hire A Qualified Contingent Recruiter 8/7/2023

   It is important for the pharma, biopharma, and medical device industries to obtain the most qualified candidates during these fast-paced technological times for either the short- or long-term (i.e., specialized consultants) or direct hire full-time employees. In this article, we focus on hiring the right qualified contingent recruiter (contingency and retained search).

5. 4 Tips For Medical Device Design Success 1/12/2022

   We are all eagerly anticipating what 2022 will bring us. This author found that when developing a forward vision, it always helps to look back and see what we learned in the past. He uses some personal experiences of designing surgical robotics for these 4 tips.

6. Solving Bioassay Challenges For Cell And Gene Therapies 7/1/2022

   A recap of USP's bioassay training workshop that included regulatory considerations, analytical validation, and case studies related to bioassays for cell and gene therapy products.

7. 3 Steps To Achieve Total Quality Management In Pharma Manufacturing 2/17/2023

   How can your company capitalize on the latest quality management trends by adding Total Quality Management tools to their toolboxes?

8. The 6 Pillars Of Effectively Managing Up In Clinical Development 7/22/2021

   Managing up, regardless of title, can be a challenging skill to master from the onset. Laurie Halloran and Michelle Pratt of Halloran Consulting share their 6 key lessons that they've learned along their careers in clinical development. This article will help you manage your relationships with your colleagues in a more senior role, while also positioning yourself for success.

9. Is The SDV In Risk-Based Monitoring Misunderstood?

   What’s in a name?  Not much according to Shakespeare.  But the man who penned “A rose by any other name would smell as sweet” was a 16^th century poet and playwright, not a 21^st century clinical research professional.  For us, names matter.  Despite recent efforts to standardize the definition of Source Data Verification (SDV), the term still means different things to different people, and that needs to be navigated very carefully. By Laurie Meehan, Polaris Compliance Consultants

    

10. Impurity Control Strategies For Therapeutic Peptides 8/12/2022

    Peptides are an important class of molecules placed between small molecules and biomolecules. Synthetic peptide-related impurities can originate from raw materials, manufacturing processes, degradation, and other causes. This article shares perspectives and recommendations discussed at USP's recent 2022 workshop on the topic.