Industry Insights

31. Bringing Allogeneic Cell Therapy To Patient Care 11/1/2022

    Bringing allogeneic cell therapy to patient care will require flexible, closed, and automated solutions to support the treatment options and increasing scale of the industry.

32. How To Choose The Right CDMO Partner For Fill & Finish 11/24/2025

    CDMO selection requires evaluating experience, quality standards, and flexibility. Assess technical transfer skills, supply chain security, and collaborative approach for a reliable, long-term project fit.

33. Considerations For Microbial Enumeration Methods When Working With CDMOs 1/23/2023

    In microbial enumeration testing, the product-specific interferences are addressed during method development. The execution can vary between laboratories. This article examines general considerations, membrane filtration, and the pour plate method.

34. Pediatric Dosage Form Development: Taste/PK Assessments, Clinical Supplies And Commercial Manufacturing 6/8/2022

    Given that in-house Large Pharma and the CMO service sector have traditionally focused on high-volume and low-variation drug products, there is an emerging industry need for smaller-scale, batch manufacturing.

35. Facility Design For OSD Continuous Manufacturing 12/29/2022

    Facility design for continuous manufacturing of oral solid dose (OSD) drugs differs significantly from design of facilities dedicated to batch processing. The primary differences reside within the facility layout, in terms of consolidation of unit operations, utility sizing, and limited manual process involvement, which minimizes the number of required personnel.

36. Soluble Versus Insoluble Expression In Microbial Fermentation

    Expression of inclusion bodies has historically suffered a bad reputation in the industry. So, how do these two routes, soluble and insoluble, compare in terms of their advantages and challenges?

37. Key To Formulation Development Is In The Details 7/20/2023

    Find out how to face the challenges in tablet manufacturing environments through supportive vendor partnerships.

38. FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs 5/4/2023

    In April 2023, the FDA issued an updated guidance superseding and replacing the previous 2020 document about managing drug shortages and explaining what was expected of industry and how the agency was going to manage the shortfalls. This article summarizes the guidance in a helpful FAQ format.

39. EU Module 15 Safety Communications 3/26/2013

    On January 24, 2013 the EMA’s latest Good PV Practices Module 15 on Safety Communications came into force. By Bart Cobert

40. Successful Regulatory Submission Via The Trifecta Of Awesomeness 1/17/2025

    Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.