Newsletter | June 27, 2025

06.27.25 -- AI's Potential To Aid Multispecific Analytical Characterization

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Webinar: Best Practices for PUPSIT Assembly Design and Operation

This webinar explores the design and implementation of PUPSIT in sterile filtration, covering regulatory expectations, system configurations, equipment layout, and integration into existing processes. It includes practical examples, design challenges, and best practices for integrity testing. Key topics include regulatory guidance, single-use integration, common test devices, and pitfalls to avoid, with a Q&A session for participant-specific concerns. Click here to learn more.

FOCUS ON QUALITY/ANALYTICAL METHODS

AI's Potential To Aid Multispecific Analytical Characterization

Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies.

 

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.

Linking mAb Product Quality Profile Changes To Your BioProcess

Optimize your bioprocess and product quality with high-frequency data. Discover how to streamline mAb characterization and link process changes to product attributes.

Overcoming The Challenges Of Product Concentration Monitoring At A CDMO

See how simplified, in-line analytics are changing the way CDMOs manage product concentration in fed-batch and perfusion processes.

Analytics: A Referee Between MSC-EVs' Nature And Nurture

Like a referee in a contest, advanced analytical methods are essential to mediate the push and pull of different factors influencing therapeutic efficacy.

Real-Time Viable Particle Detection For Definitive Root Cause Investigation

Investigations into viable air excursions are difficult to perform using traditional methods. Discover why a real-time viable particle counter is key to providing process improvement.

2025 State Of Validation: Key Insights

Discover what’s driving change in validation in your industry in 2025 by exploring key Insights for a first look at this year’s top trends, challenges, and opportunities in validation.

Evaluating The Expression Patterns Of Multiple Inhibitory Receptors

Discover how an innovative approach to interpreting T-cell exhaustion and inhibitory receptor expression is paving the way for innovative therapeutic approaches aimed at rejuvenating T-cell function.

Streamlining Drug Development Through Bioassays, Functional Assessments

Discover how strategically selecting and applying the right functional assessments can unlock the full potential of your therapeutic candidates and accelerate their path to success.

IVT mRNA Encapsulation Efficiency Assessment

In vitro transcribed mRNA revolutionizes biotherapeutics, which necessitates thorough quality assessments. Discover how an analyzer system enhances encapsulation efficiency and critical quality attributes in IVT mRNA workflows.

Best Practices In HCP Assay Development, Integration Of Advanced Orthogonal Methods

Learn the best practices in HCP immunoassay development, common mistakes and misconceptions , and advanced orthogonal methods of immunoaffinity chromatography and mass spectrometry.

Reshaping Biotherapeutics Development At Johnson & Johnson

Learn how innovative protein stability technology is providing deeper understanding and quality control for biotherapeutics within demanding, regulated pharmaceutical environments.

Product Transition Guide: Legacy Protein A Resins To Praesto AP+80

Streamline mAb production and cut costs with advanced chromatography resins. This guide explores transitioning to high-efficiency options, comparing performance and key factors for seamless integration.

Excipient GMP: Elevating Standards In Cell Culture Solutions

The quality of non-active ingredients, or excipients, directly impacts product safety and efficacy. Learn why Excipient GMP is vital for cell culture solutions and how it elevates manufacturing standards.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Commissioning, Qualification, Regulatory Compliance Services - CAI

Protein Analytics - Aragen

Accelerate Biologics Development With Electroporation Technology - MaxCyte, Inc.

Thermal Analyzers For The Most Demanding Biopharma Applications - TA Instruments

FOCUS ON REGULATORY

Unlocking The Potential Of Digital Transformation Tools In Biopharma

Why do many BioPharma organizations still struggle to gain the crucial benefits they desire from their data and digital transformation tools?

What Is The Position Of Regulatory Authorities On PUPSIT?

PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

Why And Where To Monitor In Aseptic Processing Areas

Annex 1 mandates a risk assessment to identify optimal sample point locations. Explore factors in risk assessment, equipment selection, and system design to maximize data value.

REGULATORY SOLUTIONS

SecurityLink HPLC/UHPLC Fingertight Fittings - Danaher Life Sciences

Flexible Manufacturing Solutions, Services To Meet Evolving Needs - Jubilant HollisterStier

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