Newsletter | February 23, 2024

02.23.24 -- Getting Out Of The Doldrums: Analyzing And Kickstarting Organizational Quality Maturity

FEATURED EDITORIAL

Analyzing And Kickstarting Organizational Quality Maturity

It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.

INDUSTRY INSIGHTS

To GMP Or Not To GMP? That Is The (Plasmid) Question

As critical raw materials for viral vector production, plasmids are in high demand. Finding an experienced, GMP grade plasmid supplier for your process can mitigate risk and yield reliable results.

Leveraging Novel Analytical Approaches For Advanced Therapies

Review the advantages and limitations of transcriptional assays versus reporter gene assays and how the transcriptional assay compares to ddPCR and flow cytometry for analysis of CGTs.

Scale-Up And BLA Planning For Microbial Biomanufacturing

Early planning for scale-up and biologics license application activities can maximize your chances of success by allowing sufficient time to develop launch options and prevent costly delays and setbacks.

Designing An Environmental Monitoring Solution For cGMP Manufacturing

Environmental monitoring in cleanrooms should be performed using suitable techniques that meet the needs of the risk assessment. Learn about the requirements, typical instrumentation features, and more.

Five Biggest Considerations When Choosing A Buffer Management Solution

Discover the five most significant considerations when choosing a buffer management solution that will aid manufacturers trying to decide which is suitable for their unique circumstances.

CCIT Solutions For The Pharmaceutical Industry

The quality and effectiveness of drugs significantly depend on their packaging. Explore a wide range of leak testing methods that address package integrity challenges in the life sciences industry.

Fundamentals Of Real-Time Viable Particle Monitoring: How Does It Work?

Real-time viable particle monitoring instruments have been available for over five years. Learn in detail about this technology and how it is used to detect viable particles in real time.

Leveraging A Biomanufacturing Legacy To Support New Business

Seven diverse experts discuss how Grifols Recombinant Protein CDMO's legacy and recent investments support its future in providing recombinant protein CDMO services.

Combination Sterile Connections For Single-Use Applications

Gain insight into why combination connections are used in single-use bioprocessing and explore guidance on how single-use systems can be designed to integrate the combination connectors.

SOLUTIONS

Analytical And Testing Services

Solid Form Services

A Gloveless Aseptic Filling System For Vials, Syringes, And Cartridges

Smart-Read Biological Monitoring System

A HPLC System For Easy Method Migration

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