Industry Insights

  1. Brazil's Medical Device Market: Patient Demographics, Healthcare System, And Outlook 6/24/2020

    Government initiatives, favorable demographic conditions, and increased patient purchasing power are among the factors that make Brazil an attractive medtech investment definition. Challenges are weighed against opportunities in this article, the second of a two-part series examining the Brazilian medtech market and factors that affect it.

  2. Advantages Of A CDMO With Internal Biosafety Testing Capabilities

    Learn about three biosafety testing methods that are commonly applied: in vitro adventitious virus (IVV), species-specific virus testing such as minute virus of mice (MVM), and mycoplasma.

  3. Harnessing Analytics To Minimize Antibody Variants And Speed Up Development 7/30/2024

    Antibody heterogeneity comes in many flavors — size and charge variants, and from post-translational changes. To control them, start with thorough characterization.

  4. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

  5. All You Need To Know About Contamination Control Strategies, Part 2 5/22/2023

    In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.

  6. 5 Recommendations To Maximize CSV/CSA Outcomes 7/17/2024

    The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.

  7. Flexible Facility Design For Multi-Product Manufacturing Of CGTs 6/10/2022

    Discover principles for the success of advanced therapy manufacturing facilities that benefit developers with established platform processes to sponsors and CDMOs involved in large-scale manufacturing.

  8. 5 Novel Techniques For Solubility Enhancement 2/28/2022

    Thanks to insoluble drug delivery technologies, the practice of reformulating poorly soluble drug products to improve efficacy, patient compliance and safety has now been widely adopted.

  9. Unlock Robust And Reliable Stability Data With The Right Partner 11/19/2025

    Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.

  10. Cell And Gene Therapies: Solving Six Challenges 9/20/2021

    This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.