OP White Papers - random
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Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility
10/16/2024
The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
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Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators
4/28/2025
Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
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Sterile Filtration And Quality Risk Management
8/31/2023
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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AI Implementation To Enhance Quality
2/11/2025
Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.
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Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?
9/5/2023
Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.
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The Relevance Of Polymorph Screening In The Pharmaceutical Industry
3/31/2025
Polymorph screening identifies different solid forms of active pharmaceutical ingredients, optimizing drug stability, solubility, and manufacturability. This process ensures quality, regulatory compliance, and intellectual property protection in pharmaceutical development.
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Development And Regulation Of Veterinary Monoclonals
2/8/2024
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
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Inspecting On The Edge — Understanding Punch Tip Wear
7/30/2024
Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?
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Analytical Development Services
4/28/2025
Understand the basic principles of analytical development for cGMP assays and the assays that are generally relevant to major biopharmaceutical modalities.
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Preclinical Immuno-Oncology Models For CAR T-Cell Therapy Development
5/21/2025
The following preclinical IND-enabling oncology studies conducted by scientists at Aragen over the past 10 years highlight the role of robust preclinical models in advancing the fight against cancer.