Newsletter | August 29, 2024

08.29.24 -- Wearable Injectors: An Alternative To Traditional Intravenous Administration

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Connect science and compliance at the 19th annual PDA Pharmaceutical Microbiology Conference, October 7 - 9 in Washington, DC, and navigate the crucial nexus between scientific advancement and regulatory adherence! Don’t miss out on directly interacting with the experts, poster presentations, and the Exhibit Hall where leading companies will showcase the latest technologies, equipment, and applications. This conference sells out quickly! View the agenda and register today.

FEATURED EDITORIAL

Report: Single-Use Bioreactor Uptake Plateaued, Other SUT On The Rise

BioPlan Associates' latest manufacturing survey found signs of a maturing market and strong demand for innovation upstream and downstream.

Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations

ICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.

Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection

This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.

INDUSTRY INSIGHTS

Wearable Injectors: An Alternative To Traditional Intravenous Administration

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

Understanding Injectable Drug Container Closure Systems

Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

5 Areas To Focus Your QRM Strategy For Sterile Drug Products

Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.

NEWS HEADLINES

Tanvex BioPharma USA, Inc. Achieves Dual U.S. Regulatory Milestones: FDA Approves Nypozi And FDA Accepts Biosimilar Biologics License Application For TX-05

Biosimilars Forum Calls On CMS To Support Lower-Cost Biosimilars And Increase Access For Patients

GlycoNex Successfully Completes Phase 1 Study Of Denosumab Biosimilar, SPD8