Newsletter | June 20, 2025

06.20.25 -- We Must Rethink The Solvents We Use For Peptide Synthesis

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Transforming the Biopharma Supply Chain, eData Solutions for Agility and Manufacturing Efficiency

Watch our engaging webinar to discover how eData empowers biopharma supply chains with process automation, critical analytics, and predictive logistics. Learn how manufacturers can proactively mitigate disruptions and adopt a standardized digital platform for resilient operations here.

FOCUS ON SUPPLY CHAIN

We Must Rethink The Solvents We Use For Peptide Synthesis

While the effectiveness of GLP-1 in weight loss is good news, the use of organic solvents in the GLP-1 synthesis and purification process is a growing pain that needs to be addressed.

The Case For Early Use Of cGMP Raw Materials

Using cGMP grade reagents earlier makes for a seamless transition while maintaining quality and viability.

Cold-Wall Or Convection? Critical Considerations For Application Selection

Explore both traditional cold-wall and convection technology options thoroughly to discern which is most suitable for meeting your cold storage requirements for upcoming projects.

Polymer Technology Takes Freeze Containers Beyond The Breaking Point

Learn about new materials being considered for single-use cold chain storage containers to reduce or eliminate issues with durability at cold temperatures.

SUPPLY CHAIN SOLUTIONS

Flexible Freeze Containers - W.L. Gore & Associates

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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 PROCESS ENGINEERING

Process Development For Lyophilized Products

Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

Understanding Magnetic Tweezers Use In Single Molecule Microscopy

Magnetic tweezer experiments often seek to measure changes in the extension or relaxation of a polymer, a functionality useful in exploring how different enzymes manipulate polymer structures.

Considerations In CMC For Antibody-Drug Conjugates

The complex nature of ADCs necessitates meticulous attention to CMC. Gain valuable insights for navigating CMC development, ensuring the delivery of safe and efficacious biopharmaceutical products.

Complexities And Pitfalls Associated With cGMP Tissue Sourcing

Review the elements of a complex process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity and pass BLA approval.

Improving Safety And Efficacy With Charged Variant Characterization

Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.

Lyophilization: Protecting And Preserving Biologics

Discover how lyophilization revolutionizes biologic drug manufacturing and ensures potent, stable treatments for complex diseases.

Genomic Medicine Demands Manufacturing Innovation

The promise of novel therapeutic modalities can only be realized when effective science is paired with efficient manufacturing to provide cost-effective therapies to patients in need.

Identifying New, Enhanced Device Delivery Solutions For Chronic Diseases

Needle innovations, like the use of ultra-thin wall technology for prefilled syringes, support the delivery of drugs with greater volumes and viscosities, which greatly enhances end-user experience.

Charting A Successful CMC Journey For Your ADC Drug Product

These real-world case studies highlight best practices and strategies to optimize bioconjugate drug product tech transfers and supplies in the clinical or commercial phase.

ADCs: The Next Phase Of Innovation

Explore the pivotal advancements in ADCs that focus on high-DAR, multispecific designs, and novel payloads, while addressing challenges in manufacturability, scalability, regulatory acceptance, and commercial viability.

Universal AAV Enhancer For Better Titers, Quality, And Lower Costs

AAV therapies require high quality and high titers of viral genomes per dosage, prompting the need for a more efficient AAV manufacturing method to reduce overall costs.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

Pioneering Scalable Solutions In AAV Manufacturing And Testing

Learn how pharmaceutical and biotech companies can leverage cutting-edge technology to bring transformative gene therapies to market, making treatments more readily available to patients worldwide.

Demonstration Of Scalability For A Novel Fixed Bed Reactor Platform

Designed to enable efficient scalability, a new FBR platform allows operators to use one technology, with a standardized workflow, for their process development, scale-up, and manufacturing processes.

PROCESS ENGINEERING SOLUTIONS

Equip Your Team With Expert Pharmaceutical Training - Federal Equipment Company

ADCs: Analytical Considerations For QC Release, Stability Testing, Characterization, Comparability - Labcorp Biopharmaceutical CMC Services

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