Industry Insights

  1. Leverage FDA Feedback To Communicate Risk And Boost Confidence 5/11/2022

    In this blog, discover the tips and tricks to figuring out how to translate the FDA’s feedback into a compelling investor pitch.

  2. Delivering AAV Therapies Via Candidate Screening And Feasibility Studies

    As developers begin their AAV therapy research, opting to conduct early phase studies with an experienced CDMO can help mitigate funding challenges and procure material for clinical data generation.

  3. When Should Filter Validation Be Performed? 8/21/2024

    Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.

  4. Scaling Clinical To Commercial With One CDMO 5/14/2026

    Assessing whether to stay or switch CDMOs means balancing continuity benefits, capability gaps, and transfer costs to ensure efficient, low‑risk clinical‑to‑commercial progress.

  5. Mapping The Development Of A Biosimilar Candidate: Analytical & Regulatory Decisions 10/27/2020

    This article, the first in a two-part series, details the biosimilar development path to identify and evaluate critical quality attributes for both the candidate biosimilar and the reference product, along the regulatory timeline.

  6. The Slow Drift Toward Variability And The Case For Standardization 3/30/2026

    Small, early operational decisions accumulate over time, creating hidden variability that emerges at scale, making standardization essential for stability, reproducibility, and regulatory confidence.

  7. CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward 9/17/2021

    In August 2021, the Centers for Medicare and Medicaid Services (CMS) expanded the chimeric antigen receptor T-cell (CAR-T) diagnosis-related group (DRG). While industry generally views this change as a positive development, significant uncertainties remain as to the specific immunotherapies included and how payment will change over time. To prepare, you should adjust your launch strategies.

  8. Five-Point Checklist For Pharmaceutical Scale-Up 11/29/2016

    Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. A successful drug product may go through a scaling process several times during its life cycle. The laboratory-scale batches used in clinical trials that expand to pilot-scale and finally to commercial-scale production may be just one iteration in a product’s evolution.

  9. What Happens When You Refuse To Compromise On Sustainability? 8/8/2025

    Discover how an empty building shell became a sustainable nanomedicine hub and achieved 47% energy savings and 88% fewer emissions, which sets new standards for innovation in the biologics industry.

  10. Meeting The Challenges Of Gene Therapy Logistics With The Cryoport Elite Ultra Cold 1/8/2025

    Explore how innovative logistics solutions are addressing the critical challenges of gene therapy transportation to ensure safe, reliable delivery of these life-changing treatments.