Biosimilar Manufacturing solution center
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Protein L Affinity Resin Is Ready To Move To Manufacturing
7/12/2023
Discover a protein L affinity chromatography resin that is well suited for use in biomanufacturing and offers increased binding capacities compared to other resins.
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The Cancer Drug Shortage: When Quality Fails
7/7/2023
Our industry is failing cancer patients with the current cancer drug shortage. Why is this happening and what can we do about it? This expert provides her insights from the perspective of a quality control professional.
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Key Considerations In Selecting A Robotic Solution For Endotoxin Testing
7/6/2023
The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.
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Combination Product QMS Requirements For The EU Market
6/30/2023
Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.
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Practical — And Crucial — Actions To Take Now For DSCSA Compliance
6/29/2023
Serialized data exchange, enhanced verification, and tracing, oh my! Many companies are still unprepared for full DSCSA implementation in November. Is your company one of them? Here are the important actions to take now.
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Key Post-Pandemic Trends In Global FDA Observations For Drug Facilities
6/29/2023
These authors undertook a meticulous analysis of FDA drug facility inspection data spanning from July 2021 through May 2023. The resultant trend insights provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities.
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Cleaning Process Development: Using Design Of Experiments To Determine Critical Process Parameters
6/28/2023
ASTM E3106 emphasizes that cleaning agents and cleaning processes should not be adopted randomly, nor should they be chosen simply based on what has been used in the past. In this article, part of the Cleaning Validation For The 21st Century series, let's look at which cleaning parameters are critical and what are the optimal cleaning parameter settings, through the lens of design of experiments (DoE).
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4 Key Considerations For Onshoring Or Nearshoring Of Drug Production
6/28/2023
Is reshoring or nearshoring right for your organization? It's important to undertake rigorous internal assessments to arrive at a decision. Here are four key considerations.
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ICH Q12 Post-Approval Change Management Protocol
6/27/2023
The ICH Q12 guideline includes information about the post-approval change management protocol, which aims to simplify the process of registering site changes under certain criteria through an emphasis on gaining accelerated up-front feedback from the regulator before compiling submissions. Following this protocol reduces the approval cycle by up to six months.
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The Digital Future Of CMC Regulatory Affairs
6/23/2023
This article discusses recent initiatives from the FDA, such as KASA, PQ/CMC, and the ICH SPQS. Let's look at how they could be the early birds of the paradigm shift from electronic CTDs to digital CTDs. The article also addresses what steps the industry should be taking in parallel with the authorities in preparation for this (very near) digital future.