Biomanufacturing Featured Articles

  1. Data Quality Issues At The Heart Of FDA's DSCSA Troubles 10/18/2024

    Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

  2. What's In The Leukopak Matters For Cell Therapy Manufacturing 10/11/2024

    Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.

  3. 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.

  4. Choosing The Optimal Biopharmaceutical Cold Storage Solution 9/26/2024

    Choosing the right cold storage freezer can be challenging. High storage density, modular shelving, and controlled temperature are a few key considerations for superior long-term cold storage.

  5. A Guide To Pharmaceutical Cold Chain Management 9/26/2024

    Pharmaceutical cold chain management ensures temperature-controlled storage and transport of sensitive drugs. Learn about the key freezing ranges and their importance for various biopharmaceuticals.

  6. Transport And Storage Of Antibody Drug Conjugates 8/14/2024

    Explore the benefits of single-use technologies to enhance safety, streamline your operations, and elevate your biopharmaceutical processes as they relate to ADCs.

  7. Solving 5 Overlooked Challenges In ADC Manufacturing 8/14/2024

    Delve into the intricacies of ADC production and learn how cutting-edge technologies are being deployed to overcome these hurdles to bring life-saving treatments to patients.

  8. The Patchwork Of Outsourced ADC Manufacturing 7/29/2024

    Antibody-drug conjugate (ADC) manufacturing is complicated, to say the least, and it relies on a diversity of expertise. In a recent Bioprocess Online Live event, Chief Editor Matt Pillar talks with expert panelists about how this unique modality requires unique manufacturing considerations.

  9. Optimizing End-To-End Contract Analytical Support For Cell And Gene Therapies 7/11/2024

    The development and production of CGTs presents unparalleled complexities. Learn how a partner with robust end-to-end services can help you overcome challenges at every step of the drug lifecycle.

  10. New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability 6/28/2024

    A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.