Newsletter | July 31, 2025

07.31.25 -- Relationship Equity With CDMOs Is Real, Take It From A Packaging Pro

INDUSTRY INSIGHTS

Adapt Or Fail: The Urgency Of Pandemic Preparedness For Sterile Injectables

A successful large-scale public health emergency response requires adaptable manufacturing capabilities, an experienced workforce, and effective private-public partnerships.

Virtual Quality Audits — Overcoming Limitations

A properly executed virtual audit facilitates thorough qualification, condenses production timelines, enhances relationship-building, and provides early insight into a CDMO’s capability and expertise.

Discovery Through Commercialization: A Biologic Drug's Analytical Journey

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based, biochemical assays, and more.

FEATURED EDITORIAL

Relationship Equity With CDMOs Is Real, Take It From A Packaging Pro

A pharma professional of packaging who has weaved through positions in Big Pharma says you should understand any points of leverage you have with a CDMO. However, when leverage is minimal, creating "relationship equity" is the key to win-win relationships for sponsor and provider. After a decade, a well-timed follow up conversation with Dan Marasco.

Creating Your ADC Supply Chain

Antibody-drug conjugates (ADCs) are on the rise. Supply chains to serve ADC developers can be complicated, and spread out. Reza Oliyai has some key interpretations of how these therapies can string together optimal - and at times far-reaching - supply chains.

INDUSTRY INSIGHTS CONTINUED

Focus On Your Core Business Strategy

Observe how we helped a Southeast U.S. manufacturer by transitioning key staff, reducing costs, and fully managing a compliant GMP QC lab program.

Formulation Through Manufacturing Under One Roof

Partner with a CDMO that understands the unique challenges of emerging biopharma, providing expert guidance in formulation development, manufacturing, and regulatory navigation.

Streamlining Antibody Capture With Multi-Column Chromatography

Explore innovative solutions to overcome the limitations of traditional batch chromatography, improving efficiency, reducing costs, and optimizing production for complex biologics like monoclonal antibodies.

Tips For Successfully Scaling From R&D To Manufacturing

By partnering with a trusted company that offers expertise in navigating the challenges of scale up, drug developers can have confidence in their ability to successfully bring their products to market.

Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

Examine the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

Optimizing The Progression Of Biotherapeutic Candidates To FIH Studies

Consider 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.

SOLUTIONS

Reconstituted Nasal Epithelium As A Model For Nasal Drug Delivery

Examine a human-relevant model that outperforms frozen mucosa and aligns better with clinical outcomes for opioid formulations.

Use The Right Tools To Improve Cell Lines And Production Yields

Learn about antibody production and purification, as well as antibody humanization, while exploring an integrated pipeline that enables the direct application of machine learning tools.

Dream Plant: Within Your Reach. Built For Your Success.

As pressure to accelerate timelines mounts, finding a CDMO committed to optimizing processes with innovative technologies is key for adding efficiency while maintaining quality standards.

Speed Ahead With Transient Expression System

Streamline your journey to market by using the same proven CHO cell line and vectors from discovery through to commercial production.

Capacity Update April 2025: Fill/Finish

Witness how proven sterile fill-finish expertise, high-potency capabilities, and customizable cleanrooms can support your product from development to commercialization.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

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

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