Newsletter | December 2, 2025

12.02.25 -- We're A Virtual Biotech. CDMOs Should Treat Us As A Priority

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Best Practices, Strategies, And Utilization Of Novel Biological Responses For Robust Cell-Based Potency Assays

Learn how to confidently evaluate the biological activity of your therapeutics while ensuring its potency and efficacy with a GMP-compliant potency bioassay, designed to deliver precise and reliable real-time assessments for GMP release and stability testing. Click here to learn more.

FOCUS ON OUTSOURCING

We're A Virtual Biotech. CDMOs Should Treat Us As A Priority

Outsourced Pharma Chief Editor Louis Garguilo says he's sure some readers will smirk at this headline. CDMOs are running a business; they may attempt to treat all customers equally, but they focus where the most financial gain is. Nonetheless, according to a very experienced outsourcing professional, there's nothing humorous here at all.

Breaking The Cell Therapy Manufacturing Bottleneck

Discover the potential of T1 cell-derived nanoparticles (CDNPs) to accelerate T-cell activation. See how CDNPs’ unique mechanism of mimicking physiological immune stimulation positions them for broad use.

The Key To Viral Vector Success

Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.

Stopper Migration In Frozen Pre-Filled Syringes

Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

Antibody-Drug Conjugate (ADC) – From Bioassays To Linker-Payloads

ADCs have emerged as a promising class of targeted cancer therapies. Explore linker-payload design elements, conjugation and characterization of ADCs, and the different bioassays used to screen ADCs.

Put Your AAV On The Fast-Track To The Clinic

Review an innovative method to fast-tracking AAVs through a platform approach that easily scales as the project progresses to late-stage GMP production and to market.

Best Tech Transfer Practices To Optimize Clinical And Commercial Supply

Facing challenges transferring your biological product from development to manufacturing? Delve into strategies for tech transfer processes, ensuring regulatory compliance, quality, and consistency.

Expert Insights On Outsourcing In A Dynamic Biopharma Landscape

An end-to-end, multi-plant biomanufacturing model enables faster timelines, greater flexibility, and consistent global quality, turning CDMO partnerships into a sustained competitive advantage.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

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

The Challenges Of Moving A Bioconjugate From Clinic To Market

Working with a partner that provides a one-stop shop for bioconjugate development and manufacturing helps prevent missteps that threaten the delivery of life-saving drugs to patients who need them.

Collaborate With A Partner To Bring Your Rare Disease Therapy To Clinic

Choosing the CDMO best suited to manufacture your rare disease therapy can be challenging. Ideally, a CDMO will prioritize your goals while working to ensure quality and regulatory success.

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.

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Live Event: How Digital Tools Are Accelerating Biopharma Development

Register today for this digital event led by Bioprocess Online’s chief editor, Tyler Menichiello, features industry experts who will share for an engaging panel discussion on how companies are deploying advanced technologies and tools to accelerate biopharmaceutical development. This event is free to attend thanks to Cytiva.

OUTSOURCING SOLUTIONS

Capacity Update October 2025: Large Molecule - AGC Biologics

You Make The Discovery. We Help Make It Reality. - Avid Bioservices

mRNA/LNP Development And Manufacturing Services - Lonza

Capacity Update October 2025: Large Molecule - Boehringer Ingelheim Biopharmaceuticals GmbH

The Power Of Small: Nanoplasmid Vector Platform - Aldevron

Handle Your Drug Product With The Highest Quality And Safety - FUJIFILM Biotechnologies

Best-In-Class Nanodevelopment Capabilities - Nanoform

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