Newsletter | June 30, 2025

06.30.25 -- Lonza Bets The House On Biologics. What's It Mean For You?

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Webinar: Navigating the CMC Regulatory Landscape during Protein Medicinal Product Development and Manufacturing

This webinar outlines the evolving CMC regulatory landscape for protein-based drugs, from preclinical to post-market stages. Through case studies, it shows how Lonza supports clients with integrated regulatory services. Key takeaways include the value of strategic planning, adapting to varied agency expectations, and partnering with experienced CDMOs to ensure regulatory success. Click Here to learn more.

INDUSTRY INSIGHTS

AI-Powered Digital Pathology For Pulmonary Fibrosis Biomarker Quantification

Uncover how technology is revolutionizing the detection and quantification of pulmonary fibrosis markers in whole-lung sections, offering new opportunities for clinical research.

Navigating Sterile Injectable CMO Selection

Learn how to carry out an effective technical and quality assessment and what specific criteria to prioritize when selecting a sterile injectable CMO partner.

Virtual Quality Audits — Overcoming Pandemic 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.

FEATURED EDITORIAL

Lonza Bets The House On Biologics. What's It Mean For You?

It’s a large and universally recognizable CDMO, so this matters. Swiss-based powerhouse Lonza will focus entirely on biologics, and “advanced synthesis” such as complex modalities including antibody-drug conjugates (ADCs), cell and gene therapies (CGT), and mRNA-based therapeutics. What does this say about the future of development outsourcing and our industry? Will other CDMOs follow suit?

You Need 'Brutal Honesty' When Outsourcing

Our Outsourced Pharma Live speakers were adamant: You need a clear and honest assessment of what both the sponsor and CDMO need and bring to the relationship.

INDUSTRY INSIGHTS CONTINUED

Understanding And Mitigating Oxygen Heterogeneity In Large-Scale Bioreactors

Review how oxygen heterogeneity, caused by pressure variations and other factors in large-scale bioreactors, can significantly impact cell growth and product yield.

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.

Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk

Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

Improving Safety And Efficacy With Charged Variant Characterization

Consider 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.

Overcome Common Challenges Through Partnership

The pre-filled syringe space is one of the fastest-growing sectors, offering greater patient safety and lower costs. But pre-filled doesn’t translate to easily filled; there are obstacles to overcome.

3 Keys To Success When Planning With Your CMO Partner

Once you've identified a CMO partner, how do you ensure success? The secret: planning as early as possible – while your product is still in preclinical or clinical development.

SOLUTIONS

Capacity Update July 2024: Large Molecule Development

Gain insights into boosting efficiency, fostering innovation, and how integrated capabilities generate value for innovators.

Expertise In Commercial Fill-Finish For More Than 30 Years

Examine how a new high-speed aseptic filling line can help bring your product to market with speed and efficiency while ensuring safety and high product quality.

Years Of Providing Manufacturing Solutions To Patients

Explore how we’ve spent the past 60 years improving healthcare and shaping the future of injectable pharmaceuticals and where we plan to head next.

Particle Control In Biopharmaceuticals

Observe how we offer a holistic approach to DP development that anticipates and prevents problems early, ensuring the result is a product that is fit for purpose.

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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