Newsletter | July 25, 2025

07.25.25 -- Peeling Back The Layers Of Radiolabeled Peptide Production

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Single-use systems (SUS) are everywhere—but standardization hasn’t caught up. Join Bioprocess Online Live for a timely discussion on how the lack of SUS standards is impacting implementation, tech transfer, and supply chain stability—and what the industry must do next. Registration is free thanks to the support of CPC.

FOCUS ON SUPPLY CHAIN

Peeling Back The Layers Of Radiolabeled Peptide Production

From the moment radiolabeled drugs are made, it’s a race to get them to patients. Radioactive decay is just one of many complications. Here’s one company’s approach.

 

 

Raw Materials Considerations When Manufacturing Biologics

Discover key considerations for qualifying GMP raw materials in CGT manufacturing, emphasizing quality control, supplier selection, and regulatory compliance to ensure therapeutic safety and efficacy.

 

Understanding Refrigerator, Freezer, And Incubator Performance Metrics

Learn more about how these tools are vital to scientific progress to preserve samples, support experiments, and ensure the integrity of life-saving research in every modern laboratory.

 

Preventing Gas Ingress In Single-Layer Fluoropolymer Bags

While barrier films in bags can be useful for cold chain applications, they do not fully protect against gas ingress and ignore other sources of permeability.

 

Solving 5 Overlooked Challenges In ADC Manufacturing

Delve into the intricacies of ADC production and learn how cutting-edge technologies are being deployed to overcome these hurdles to bring life-saving treatments to patients.

SUPPLY CHAIN SOLUTIONS

DEHP-Free CryoProtect™ Bio-Container - Charter Medical

FOCUS ON PROCESS ENGINEERING

Using Algae To Manufacture Oral Biologics With Lumen Bioscience's Craig Behnke, Ph.D.

Lumen Bioscience is putting the farm in biopharma — literally! In this episode of Better Biopharma, Lumen's EVP of production and development, Craig Behnke, Ph.D., explains the company's chlorophyll-powered approach to bioprocessing using photosynthetic cyanobacteria.

 

 

Embracing Quality-By-Design For Enhanced Development Strategies

In the biopharmaceutical development world, Quality by Design cuts risk, streamlines processes, and speeds up regulatory approval.

 

Optimizing The Progression Of Biotherapeutic Candidates To FIH Studies

Learn actionable strategies that can lead to higher success rates and smarter resource investment, paving the way for a successful path to IND submissions and commercialization.

 

A 5-Step Guide To Achieving Your Biosimilar Milestones On Time

As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.

 

Process Development: Understanding Its Importance And Proper Execution

High-quality process development aims to maintain a consistent process from toxicology through to GMP production runs, and can be aided by a capable, adaptable CDMO.

 

Mastering QbD For Process Validation And Biologics Manufacturing

In this presentation, industry-leading bioprocess experts explore the challenges and opportunities that arise when implementing Quality by Design (QbD) in biologics development and manufacturing.

 

Protein Stress Testing

Start your forced degradation studies early to uncover molecular risks, strengthen product stability, and ensure regulatory-ready development from the start.

 

Optimize mAb Process Development To Reach Your Goals Quickly

In the pursuit of making your mAb process as efficient as possible, it is vital to identify the cell line, media, feed, and resin that best suit your productivity goals.

 

Balancing The Scales: The Ups And Downs Of Bioprocess Scale-Up

Learna about the complexities of scaling decisions with insights from biopharma developers and a CDMO. Discover their shared interest in achieving successful scale-up and strategies for avoiding common pitfalls.

 

GENE TO GMP*: First-In-Human In 8 Months With Optimized Cost

We drive innovation and excellence in biologics, offering integrated solutions that help clients efficiently advance their research and successfully bring their products to market.

PROCESS ENGINEERING SOLUTIONS

Microcalorimeters For In-Depth Characterization - TA Instruments

Process Development Services - RoosterBio

Nanopositioner Focusing Elements: Nano-F Series Datasheet - Mad City Labs, Inc.

Meet The Most Effective QbD Implementation Platform - ValGenesis

IVGE Scale-Up And Value - Roche CustomBiotech

Flexible Manufacturing Solutions For An Evolving Industry - Jubilant HollisterStier

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