Newsletter | February 14, 2025

02.14.25 -- They Said What? Unexpected Insights Into CDMO Selection

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FEATURED EDITORIAL

They Said What? Unexpected Insights Into CDMO Selection

A series of conversations with seasoned biopharma executives have revealed surprising insights into CDMO selection. In this overview, I explore key topics such as preparation strategies, stakeholder responsibilities, and recent intriguing behaviors observed among CDMOs.

Computer Systems Validation Pitfalls, Part 4: Inattention To Details

The authors conclude their four-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.

INDUSTRY INSIGHTS

Media Selection For In Vitro Testing Of Poorly Soluble Drugs

Lonza principle scientist Deanna Mudie Ph.D. covers the design of dissolution media to support biopredictive dissolution testing and how the properties of a drug and formulation affect performance.

Fundamentals Of Particle Size Analysis

Explore the importance of particle size characterization and the advanced analytical techniques employed to assess micronized particles effectively.

Shedding Light On Photostability Forced Degradation

Ensure drug stability and safety with forced degradation and photo-stability testing, following ICH and FDA guidelines to identify degradation pathways and light exposure risks.

Building A Resilient Supply Chain For Your Next-Generation Peptide Therapeutic

As peptide therapeutics continue to establish themselves as a leading technology for treating chronic indications, drug sponsors must identify reliable building block suppliers to secure high-quality materials.

Implementing A Disaster Recovery Plan

When facing a malfunction, having an effective disaster recovery plan can make the difference between a swift fix, and losing your samples and time.

From Bench To Batch: Strategies For Scaling HPAPI Production

Highly potent materials bring additional challenges to manufacturing processes. Examine considerations for optimizing HPAPI production methods to reduce risk and deliver therapies to patients with speed.

SOLUTIONS

Contract Pharmaceutical Blister Packaging Services

Consider contract blister packaging services from a partner that can produce blister packaging in several different forms, including regular thermo-form, cold-formed, and heat-sealed blister cards.

Technology To Overcome Absorption Hurdles And Solubility Limitations

For poorly soluble drugs, overcoming absorption hurdles can hinder development. Consider a solution that empowers researchers to overcome solubility limitations and accelerate drug development.

PBPK Predictive Modeling Services

Early identification of potential absorption risks is critical for rapid and efficient drug development. Lonza's PBPK modeling services are designed to de-risk your drug development program.

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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