Industry Insights

  1. Aseptic Filling And Processing Considerations For Biosimilars 10/11/2023

    One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Explore the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.

  2. Leveraging ISA-95 In A Pharma 4.0 World 1/22/2024

    Explore core elements of the ISA-95 specification and how life sciences manufacturers can apply them within an integration solution designed for industrial data modeling, delivery, and governance.

  3. An Intro To Environmental Monitoring And Cleaning For Aseptic Environments 8/21/2017

    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. This article will address concepts of environmental monitoring and the importance of disinfectant efficacy and proper cleaning in cleanrooms.

  4. Overcome Single-Use Customization Misconceptions 6/21/2022

    Single-use strategies and tools are constantly evolving to better serve industry needs, and adept solutions providers can help streamline development with simple, custom adaptations.

  5. Beyond Conventional: How This CDMO Model Is Empowering Emerging Biotechs 10/2/2024

    For emerging biotechs looking to refine their development processes and boost their chances of commercial success, exploring these partnership opportunities could prove invaluable.

  6. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

    When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.

  7. Eliminating Analytical Bottlenecks And Streamlining Drug Discovery 5/13/2024

    Advanced analytical methods play a crucial role in drug development pipelines by providing accurate data for informed decision-making. However, the increasing complexity and volume of data present challenges in managing and analyzing it effectively.

  8. Regulatory Intelligence: It's More Than Just Compliance 12/3/2021

    Every pharmaceutical company is under pressure to monitor the changes that are taking place in the regulated landscape and respond to them accordingly. Regulatory intelligence activities include collecting, evaluating, and analyzing various pieces of information to position your company for success.

  9. Advanced, Cost-Saving Techniques Improving Cell Therapy Production 9/30/2024

    Low throughput and intense resource demand limit patient access to cell therapies. Automation and in vivo manufacturing are poised to lower those barriers.

  10. Single-Use Technologies: A Game Changer For Expanding mAb Production 3/4/2022

    A biotech company that this author worked with had an expanding pipeline and needed to increase its manufacturing capacity, so single-use technologies were implemented from media prep through buff prep, to seed train and through the downstream process. The company saw a dramatic reduction of production costs.