Newsletter | May 16, 2025

05.16.25 -- The EU Biotech Act Has Been Delayed — Here's What That Means

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Multispecific molecules bring added complexity to downstream purification—think incorrect chain pairings, aggregation, fragmentation, and lower yields. Join Bioprocess Online Live as we explore how developers are addressing these challenges to achieve high purity and efficient processes. Gain insights into key considerations for downstream teams when designing purification strategies for these advanced biologics. Registration is free thanks to the support of Thermo Fisher Scientific.

FOCUS ON REGULOTORY

The EU Biotech Act Has Been Delayed — Here's What That Means

By Jackie Mulryne and Eleri Abreo, Arnold & Porter

First due at the end of 2025, the act has been delayed until late 2026, which suggests key issues that many say hobble innovation will go unaddressed for longer.

Compressed Gas Risk Assessment: A Significant Step In Your CCS

Webinar | Particle Measuring Systems

Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

Preparing For FDA Pre-Approval Inspection: Quality And Regulatory Topics

Webinar | Lonza

Consider these strategies for meeting quality and regulatory requirements in cell and gene therapies that can also help to identify issues early, reduce risks, and prevent delays and rework.

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Explore the latest biotech equipment and solutions — all online, wherever you are.

Don't miss the next Bio-Expo Live! This interactive, multi-day event is organized by stages of drug development and production, making it easy to find sessions tailored to your company's needs. Browse the full agenda and register for free to join the conversations most relevant to your work.

FOCUS ON QUALITY/ANALYTICAL METHODS

3 Trends Shaping The Future Of Biomanufacturing

Article | Insights from Expert Marius Müller, Ph.D., Johnson & Johnson Innovative Medicine, NanoTemper Technologies, Inc.

Technological advancements are driving significant change in biomanufacturing. An industry expert highlights three pivotal areas: data science, advanced automation, and process analytical technologies.

Keeping Up With New Emerging Analytical Technology

Webinar | Repligen – PAT

Explore advancements in emerging analytical technologies like Process Analytical Technology (PAT) and mass spectrometry, improving drug development through enhanced bioprocess monitoring and control.

Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis

White Paper | By Whitney Pike and Lisa Houston, Agilent Technologies

Discover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.

A Guide To Optimizing Analytical Strategies For Biologics Development

Article | By Roberta Bucci, Catalent

A miscalculated analytical approach can be costly to develop, perform, and maintain. Many organizations also lack appropriate resources to create optimal testing methods and protocols.

QUALITY/ANALYTICAL METHODS SOLUTIONS

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Experience That Accelerates Success - Bora Pharmaceuticals

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Leveraging Biologics Analytical Services - Alcami

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