Industry Insights

  1. Emerging Partnership Trends In Oligo-Based Medicines 11/6/2024

    The oligonucleotides sector is quickly evolving and seeing more industry partnerships than ever before. We caught up with DeciBio's Carl Schoellhammer and Phillip Leclair for their analysis.

  2. A Closer Look At Buffer Recycling For More Sustainable Bioprocessing 4/8/2025

    Recognizing the unexplored potential to save resources, one researcher realized consumption reduction of up to 50% during a key phase of downstream processing.

  3. Using Novel Biological Responses For Robust Cell-Based Potency Assays 12/2/2024

    Ensure the potency and efficacy of your biologic products with a GMP-compliant potency bioassay, offering accurate real-time assessments for GMP release and stability testing.

  4. The Fourth Industrial Revolution: Robotics And The Laboratory 10/20/2025

    Integration of robotics and automated systems across laboratory services significantly decreases experimental timelines, tightens precision, and enhances scientists' capacity for critical thinking.

  5. How Clinical Execs Can Embrace Technology (& How To Find Activated Patients Who Do, Too) 5/18/2021

    How can we make the clinical trial process more efficient and effective? By embracing technology (for example, AI and machine learning) and finding patients who embrace technology, too. The former deputy chief medical officer for the American Cancer Society shares his thoughts.

  6. Quantitative Systems Pharmacology Brings Value To Drug Development 1/12/2016

    Quantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.

  7. Scaling Cell and Gene Therapy Manufacturing Operations 10/13/2020

    Manufacturing autologous cell therapy products faces few key complications, which is typically why CAR-T manufacturing runs at two or three sigma operations.

  8. When Conflict Arises With Your CDMO 3/24/2025

    Outsourced Pharma Advisory Board Member Sean Eisenberg details how to handle and overcome conflicts between drug sponsors and CDMOs. This is part one of a two-part dissertation on a subject that, if you outsource, will certainly arise ... if it hasn't already.

  9. Key Regulatory Considerations For The Next Wave Of Gene Therapies 2/21/2025

    The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.

  10. A Biosimilar Applicant's (Illusory?) Right To Declaratory Relief 8/9/2018

    This article explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.