Newsletter | March 1, 2024

03.01.24 -- New DSCSA Guidance Details Layers Of Verification System Requirements

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8th CCP Summit | March 26-28, 2024 | Boston, MA

The 8th CCP Summit offers a content-rich experience with cutting-edge presentations from leading pharma and biotech, covering content across small molecules, biologics, and ATMPs. This forum will harmoniously pair technical case studies with the business case realities to leave you with the definitive answer of why NOT continuous processing. Download the full event guide to learn more.

FEATURED EDITORIAL

New DSCSA Guidance Details Layers Of Verification System Requirements

A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.

INDUSTRY INSIGHTS

Emerging Trends And Challenges For Pharmaceutical Production

Anticyclical by tradition, the pharmaceutical industry is one of the sectors that copes best with the difficulties caused by the pandemic. Learn about the growing market, emerging challenges, and more.

Four Reasons For The Rise In Blister Packaging

Here are the factors that are driving blister to the forefront of pharmaceutical packaging, and at an even faster rate than its current growth.

Biopharma Drug Development Workflow And Techniques

Drug development is a long and complex process, and every step has specific goals. Explore the relevant objectives and techniques used in each stage of antibody drug development.

Driving Sustainability In Spray Drying Through Enabling Technologies

By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.

The Advantages Of Blow/Fill/Seal Processing For Vaccine Production

Multicomponent filling and sterilizing systems represent unique advantages for vaccine production. Learn how B/F/S systems can be adapted for vaccine production without incurring any product degradation.

Accelerating cGMP Production Using Rapid Tech Transfer

A partnership between Cytiva and Teva Pharmaceuticals showcases tech transfer success through effective communication, diligent project management, and a wide range of expertise.

Aseptic Environmental Monitoring For Vaccine Manufacturing

To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.

Challenges Associated With In-Use Simulated Administration Of Biologics

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

Leveraging Bio-Functional Assays For Charged Variants Characterization

The heterogeneity of a biologic product has implications for the safety and efficacy of the final therapy. Gain insight into the challenges associated with charged variants, including mAbs and fusion proteins.

SOLUTIONS

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Data Management System For The Pharmaceutical Industry

Pilot Scale/Laboratory High Voltage Leak Detection System For IV Bags

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