Clinical Supply Manufacturing Articles

31. When Does GMP Matter In Non-GMP Settings? 4/5/2024

    Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.

32. Have We Got Novel Drug Production And Compliance Timelines All Wrong? 6/13/2024

    Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

33. Scaling RNA Production From The Lab To The Clinic 8/9/2024

    Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.

34. How To Build Clinical Supply Into Drug Development From The Start 8/21/2026

    Clinical supply can do more than execute development decisions. Bringing it in early can expose product, process, packaging, and patient-access risks while they can still be changed.

35. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

    Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

36. Compliance, Costs, And Site Readiness In CAR-T Clinical Trials 3/19/2026

    Navigate CAR-T trial complexity: uncover key compliance, budgeting, and site readiness strategies to ensure safe, efficient, and successful patient care.

37. A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies 10/2/2024

    This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. 

38. What's A “Hybrid Externalized” Manufacturing Model? 3/10/2022

    Anthos Therapeutics’ phase 2 antibody candidate abelacimab could dramatically improve the way clinicians treat very common, high-risk arterial and venous thromboembolic events. The company is exercising manufacturing creativity to maintain clinical supply. Anthos CEO John Glasspool shares on the Anthos approach to outsourcing. 

39. Managing Supply Chain Risk In Scale-Up And Multisite Trials 1/23/2026

    Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.

40. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.