INSIGHTS ON QUALITY CONTROL
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Antibody-Drug Conjugates – Catalysts For Chemistry
Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.
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Water Activity And Primary Packaging For Oral Solid Dose Products
The draft of the general chapter USP<922> says water activity determination can be used to assess the level of protection of primary packaging for an oral solid dosage product over its entire shelf life.
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Chromatography In Biologics Manufacturing: Purification Science, Resin Applications, And System Qualification
Explore chromatography fundamentals, resin selection strategies, and the regulatory frameworks required to qualify automated systems for compliant, commercial-scale biologics manufacturing.
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Compressed Gas Risk Assessment: A Significant Step In Your CCS
Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.
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Lentiviral Vector Upstream Process12/12/2025
Scalable lentiviral vector production is moving beyond adherent systems. Learn how streamlined workflows enable linear scale-up in stirred-tank bioreactors for cost-effective gene therapy manufacturing.
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The Role Of Quality By Design In Pharmaceutical Tablet Development7/30/2024
Quality by Design (QbD) ensures efficiency and high standards in pharmaceutical tablet development. Explore how this proactive approach transforms manufacturing processes and enhances product quality.
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Experience The Future Of Bioseparations4/16/2024
Learn about an HPLC System designed to improve outcomes in QC labs with ease of use and simplicity at its core.
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Building Control Strategies: It's Time To Go Digital1/24/2025
Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.
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Organ-Chips Outperform Animal Models And Spheroids8/2/2024
Examine how 780 human Liver-Chips were assessed for their ability to predict drug-induced liver injury from small molecules.
QUALITY CONTROL SOLUTIONS
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Stainlees Steel Glovebox for Cytotoxic Drug Development designed to provide personnel protection while working with powder substances.
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Sterility testing is a requirement to confirm that pharmaceutical products purporting to be sterile do not contain viable microorganisms before being released and administered to patients. So, it is vital that the method used for testing medical devices, pharmaceutical products, formulations, tissue materials, and other products is both reliable and accurate.
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FTIR Hybrid Isolator designed to provide personnel protection while working with powder substances. The enclosure features include polypropylene superstructure, black phenolic base, removable draftshield (not shown) with 3x 8” oval glove ports, minihelic gauge, Nitrogen tap, compressed air tap, vacuum tap, 3x sealed RJ45 connections, isolation switch, fan and light switch, FS1650 alarm, top mount fan with Bag-In / Bag-Out Dual 99.99% HEPA Filters, inside sliding door, emergency stop button, keyboard arm and tray, and 2x Dual 220V outlets. A 304 Stainless Steel Table with adjustable leveling pads is also included with the enclosure. Acrylic viewing panels and IP67 LED Light Tubes maximize lighting across the workspace.
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The ongoing R&D of PTI continues to build a powerful set of leading-edge inspection technologies that will bring patented and unique solutions to high risk packaging applications. There is continuous development in the field of creating new test methods for container closure integrity, seal integrity testing and package integrity testing.
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The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.