Newsletter | January 31, 2025

01.31.25 -- Will FDA Finally Enforce DSCSA Interoperability In 2025?

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With a third wave of biologics patents expiring, the race is on to seize the booming opportunities in the fast-evolving biosimilars field. What’s driving the patent scramble? What hurdles in manufacturing, regulation, and market access must be cleared for biosimilars to thrive? And how are global industry leaders carving out strategies to dominate the market? Don't miss Bioprocess Online Live happening February 4th. Registration is completely free, thanks to the support of Cytiva and Ecolab Life Sciences.

FOCUS ON SUPPLY CHAIN

Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data

The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.

Trends In Cold Chain Storage For Biologics

Packaging is critical, as biotechnology products requiring colder storage become more valuable. Find out how you can improve your temperature-controlled supply chain and meet cold chain storage demands.

Advancing ATMP Fluid Management

In this e-book we explore what ATMPs are and what they can achieve, the challenges in manufacturing ATMPs, ATMP Fluid Management, and receive expertise advice and answers to common questions.

SUPPLY CHAIN SOLUTIONS

DEHP-Free Fluid Transfer Bags - Charter Medical

FOCUS ON PROCESS ENGINEERING

Technique To Measure The Scattering Contrast And Size Of Nanoparticles

Learn more about the advantages of macro mass photometry including how quickly it can be completed, the limited sample preparation requirements, and its compatibility with aqueous conditions.

A Flexible Approach To CMC For Fab And Fc-Fusion Development Programs

Characterizing Fab and Fc-Fusion proteins and developing robust manufacturing processes can help usher them to market and provide new treatment options for diseases that are challenging to treat.

Leveraging HTS Technologies For In-Depth Characterization Of rAAV Products

Explore advanced sequencing protocols and bioinformatics solutions to achieve comprehensive rAAV characterization, ensuring precise purity and identity analysis for safe and effective gene therapies.

A Lean, Agile Business Model To Deliver High-Quality Oncologic Treatments

No two journeys through the drug pipeline are the same; the ability to leverage a variety of approaches for different products is what sets one lean biotech company apart.

Streamline Process Characterization For Successful Validation Campaigns

Explore how a stepwise approach for process characterization can help target the right experimental design and be tailored for different programs based on prior knowledge and experience.

Streamlining The Importing & Exporting Of Biological Samples

Create a seamless and predictable import and export process by working with experienced bioanalytical laboratory partners, understanding what paperwork samples require, and proactive planning.

Unlock The Therapeutic Potential Of MSC-Derived Exosomes

Explore overcoming the challenges of MSC and EV Production and how bone marrow-MSC EVs with anti-inflammatory activity are being used to treat retinal degeneration and traumatic brain injuries.

Training Biomanufacturing Operators Faster And More Effectively

Could a new approach to operator training help minimize batch loss? Learn how blended learning can enhance training effectiveness and engagement, reducing human error in your production line.

Evaluation of Lentiviral Vector Stability and Development

Discover key findings that highlight the importance of evaluating LVV stability to develop a robust purification process. 

Accelerate Your R&D And QC With These 3 Key Analysis Methods

Learn about three key thermal analysis methods for fast and effective characterization and quality control: differential scanning calorimetry, thermogravimetric analysis, and sorption analysis.

PROCESS ENGINEERING SOLUTIONS

Detergent-Based Viral Inactivation - Avantor

RevIT AAV Enhancer: Higher Titers For Recombinant AAV Production - Mirus Bio

FAQs About Stability Profiling Experiments - NanoTemper Technologies, Inc.

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