Newsletter | September 3, 2026

09.03.26 -- Catalent Says It's Not Our Facility; It Belongs To Novo Nordisk

INDUSTRY INSIGHTS

 

Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool

Transferring cell cultures between scales is challenging and error-prone. See how bioreactor scaling software predicts optimal settings to enable efficient scale-up and faster progression to clinical studies.

 

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

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

 

Aqueous Cleaning Processes

What does the BATH-O-CARD acronym represent, and how can it help you during your aqueous cleaning process?

FEATURED EDITORIAL

Catalent Says It's Not Our Facility; It Belongs To Novo Nordisk

In April, the FDA again informed us that the Bloomington, Indiana facilities — owned by Catalent until their December 2024 sale to Novo Nordisk — still haven't resolved their quality issues, adding to an inspection and remediation history years in the making. How are we witnessing this at a U.S. facility run by a name-brand CDMO and then Big Pharma? Catalent, for its part, wants to stop "inaccuracies in media coverage." Here's analysis from our own Chief Editor Louis Garguilo, with perspective from an experienced pharma professional.

 

Quality Oversight: How FDA And Pharma Are Rethinking Data, AI, Culture

Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

INDUSTRY INSIGHTS CONTINUED

 

Keeping The Client In Mind: A Customer-Centric Approach To Scale-Up

In today's fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise—see how collaboration can transform scale-up and drive confident progress.

 

Why Upstream-Downstream Alignment Determines Success

Aligning early upstream choices, downstream purification, and analytical testing prevents scale-up delays, reduces process variability, and protects timelines for complex biologics.

 

From The Army Commander To The CDMO Corner Office

A conversation on what drives CDMO success — from operational discipline and leadership to complex manufacturing challenges and industry trends.

 

Starting With The End In Mind

Complex biologics need scalable, GMP-ready development from the start. Early decisions, scientific continuity, and strong partnerships help reduce delays and rework.

 

Where Innovation And Investment Reduce Drug Development Risk

How strategic investments in development, manufacturing, and clinical supply are helping organizations reduce risk and accelerate drug development.

 

Scaling Clinical To Commercial With One CDMO

Deciding whether to stay or switch CDMOs means balancing continuity benefits, capability gaps, and transfer costs to ensure efficient, low-risk clinical-to-commercial progress.

 

IP Considerations In Drug Development For Biotech Companies

Integrate a strategic intellectual property approach early in drug development to streamline research, uncover opportunities, and maximize the return on your investment.

 

Water For Injection: Strategic Utility And The Case For Outsourcing

Water for Injection is a critical, highly regulated component of sterile drug manufacturing. Outsourcing its production offers faster timelines, reduced risk, and improved operational and cost efficiency.

 

Enhancing AAV Manufacturing Yield Via Mini-Helper Plasmid

Learn how rational plasmid engineering and promoter optimization can boost AAV productivity while reducing plasmid burden — paving the way for more efficient, scalable viral vector manufacturing.

 

N-1 Perfusion Strategies For Commercial-Ready Biologics

Uncover how modular N-1 perfusion strategies shorten seed train timelines and reduce facility strain — enabling upstream processes that scale efficiently and reliably for commercial manufacturing.

 

Quicker Development Using Cell Line Integration, End-To-End Support

Despite challenges with mammalian host cell line diversity, Lonza's mitigation strategies drive efficiency and reproducibility, maximizing cell growth and product quality.

 

Enabling Subcutaneous Delivery For Improved Patient Compliance

Administering high-dose biologics subcutaneously offers real benefits — reduced treatment burden, greater patient convenience, and improved adherence.

 

Microbial Biomanufacturing: Where We've Been And Where We Are Going

Explore the technologies driving the shift to microbial expression — and how the right outsourcing partner helps you capture the benefits of these therapeutics.

SOLUTIONS

Pull Your Fill/Finish Line Closer

One Partner, Every Step Of Your ADC Program

Capabilities Update June 2026: ADC

A Digital Platform That Monitors, Predicts, And Controls Bioprocesses

OPCU May 2026: Highly Potent Drug Development & Manufacturing

Unlocking Strategic Value Across The Biopharma Landscape

From Sequence To Clinic: Faster Decisions Through In Silico Insights

Speed, Precision, Impact: The CRO Revolutionizing Bioanalysis

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

 

Connect With Outsourced Pharma: