Newsletter | November 30, 2023

11.30.23 -- Human Performance Theories And SOPs: Human Error Prevention In Manufacturing

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FEATURED EDITORIAL

Human Performance Theories And SOPs: Human Error Prevention In Manufacturing

Standard operating procedures (SOPs) are often viewed as mere documents to be followed, rather than as dynamic tools. Drawing on human performance theories, this article explores how to create, review, and train on SOPs, as well as how manufacturing and quality teams can collaborate to improve oversight, all with human error prevention in mind.

INDUSTRY INSIGHTS

Accelerate Successful Transfer Of Recombinant Protein Analytical Assays

Learn how a CDMO that is experienced in producing and characterizing diverse recombinant proteins is essential when accelerating the successful transfer of recombinant protein analytical assays.

Collaboration For Clinical To Commercial Manufacturing Success

Begin your antibody drug conjugate manufacturing journey by finding a partner that can provide support through every phase of the conjugate life cycle, including process optimization, scale-up, and validation.

Overcoming Late-Stage API Development Bottlenecks

Meeting aggressive development timelines often demands completing remaining process and analytical tasks in parallel, as well as compensating for any lack of information.

The Role Of The Technical Transfer Executive Sponsor

Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

Extractables And Leachables: Risk Management And Analytical Solutions

Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

Bioproduction Analytics To Support Optimized Media Development

Designing and optimizing a cell culture medium can be a complex and time-consuming process, and accurate analytics are vital in streamlining media development to achieve long-term success.

cGMP Manufacturing In The Pharmaceutical Industry

Adhering to cGMP guidelines ensures that pharmaceutical companies offer customers a safe, high-quality product and that production will continue uninterrupted, reducing time-to-market and costs.

2023 Life Sciences Industry And Real Estate Perspective: Part 2

This report ranks top medtech and biomanufacturing markets by applying a concentrated analysis to our model.

How Market Research Can Inform CDMO Selection

Discover how market research is empowering decision makers while helping CDMOs tailor their strategies to better meet sponsor needs.

Improving Sustainability Via Incineration Reduction And Solvent Recovery

Wastewater incineration reduction and solvent recovery are two sustainable process techniques that can be built into the drug manufacturing workflow to significantly reduce carbon emissions and waste.

Technological Innovations In Clinical Supply Chains

Join industry trailblazers as they delve into the challenges the industry is facing, technological solutions revolutionizing the landscape, and the role digital tools will play in shaping the future.

The Benefits Of Downstream Process Connection Technology

Single-use downstream applications including chromatography, filtration, and purification create difficult environments for supplier components due to the presence of chemicals across a wide pH range. 

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