Industry Insights

1. How 3D Cultures Better Mimic In Vivo Conditions In The Field 12/16/2021

   Although the traditional 2D cell culture is still used as a primary experimental tool all across the world, we look into how 3D cultures better mimic in vivo conditions because they provide cells the physical environment they need to interact naturally.

2. Viral Aggregation In Downstream Processing Of Lentiviral Vectors 5/11/2020

   Viral vectors are vehicles for delivery of therapeutic DNA in cell and gene therapies. With over 1,000 cell and gene therapy (CGT) clinical trials underway globally, there is a growing need to address challenges in viral vector manufacturing – both upstream and downstream. Here we explore the concept of viral aggregation and its influence in every step of DSP for LVV.

3. ITC For Binding Characterization In Pharmaceutical Research 4/24/2025

   Discover an Isothermal Titration Calorimetry tool that is precise for characterizing molecular interactions, which is crucial for drug discovery and lead optimization in pharmaceutical research.

4. The OBBBA: Biopharmas Unlock R&D Expensing, Global Tax Efficiencies 8/28/2025

   Biopharma innovators may soon see major tax breaks thanks to the One Big Beautiful Bill Act (OBBBA). The new legislation introduces targeted tax incentives designed to strengthen domestic R&D and capital investment.

5. Is 'Human Error' The Cause Or The Outcome Of GMP Deviations? 10/6/2023

   Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.

6. 7 Crucial Steps In Bioanalysis To Optimize Drug Development 9/1/2024

   On the journey toward creating effective therapies, the development of a rugged method for optimizing small molecule drug development strategies plays a pivotal role.

7. Preformulation Of Excipients In Biologics Development 9/28/2023

   Most of the instability problems of a drug product come from excipients, in particular, they come from impurities in excipients. Those issues are best cleaned up in the preformulation period to determine excipient compatability.

8. A Multi-Attribute Analysis CE Platform Assesses Identity And Titer Of LVVs 3/13/2023

   As lentiviral vectors become more attractive options for CGT applications, sponsors need robust, efficient analytical platforms to accommodate upstream and downstream assessment.

9. Manufacturing Biotherapeutics Based On Synthetic Biology: Lessons Learned 7/8/2022

   In 2014, Synlogic's co-founders formed the first company that would apply the principles of synthetic biology to the creation and development of biotherapeutics. This article shares their journey in overcoming challenges in producing synthetic biotics, considering new approaches in manufacturing, and the benefits of a hybrid production model.

10. Understanding cGMPs For Phase 1 Investigational Drugs 8/15/2025

    Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.