Newsletter | November 18, 2025

11.18.25 -- Extreme Weather Is Testing Pharma's Resilience — Is It Ready?

SPONSOR

With more than 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class GMP sterile fill and finish services, deep scientific and technical expertise, and a uniquely collaborative approach to support our customers’ strategic objectives. As two industry-leading CDMOs in the ADC field, MilliporeSigma and Simtra have forged a Strategic Alliance for Drug Substance and Drug Product ADC Manufacturing with the shared goal to delivering your drug development program to market more efficiently.

INDUSTRY INSIGHTS

Advancing Moisture Determination Of Pharmaceutical Products

Learn how water activity testing offers a more predictive, non-destructive alternative to traditional moisture analysis, with insights into USP <922>, lyophilized products, and rapid headspace techniques.

Small Molecule Oral Delivery For Rare Diseases: Complexities As A CDMO

Developing therapies for rare diseases faces hurdles like high costs, small patient populations, and complex small-batch manufacturing. CDMOs offer crucial support, expertise, and flexibility.

Taking An Alternative Approach To Drug Delivery

Novel therapeutics are driving demand for alternative drug delivery methods. Explore the latest approaches and understand the formulation challenges and benefits for specific diseases.

FROM THE EDITOR

Extreme Weather Is Testing Pharma's Resilience — Is It Ready?

It may sound like a stretch, but researchers from Harvard University showed how a disproportionate amount of pharmaceutical manufacturers are in areas of climate-driven extreme weather events. Is the pharmaceutical industry currently set up to withstand them?  

INDUSTRY INSIGHTS CONTINUED

DeltaV PKM For One-Click Tech Transfer

Discover how digital collaboration can streamline technology transfer and reduce errors, as well as learn how centralized process knowledge supports efficiency and scalability across development.

Candidate Screening And Feasibility Studies For Viral Gene Therapies

Create a simple, modular path to cGMP manufacturing that minimizes risk. Examine a strategic approach for early-stage development and how it can propel therapies to the clinic and the market.

Unlocking Efficiency In Large-Scale Microbial Manufacturing

Gain insights into how expert teams and the right tools help build resilience into manufacturing systems and tackle small, often-overlooked issues before they become costly problems.

Assessing Production And Stability Of Antibody Drug Conjugate Platforms

ADCs with similar antibody sequences can behave differently due to linker and payload choices. Analytical tools reveal structural and stability differences critical to therapeutic performance.

How To Evaluate CDMO Communication: A Framework For Biotechs

Evaluate a CDMO's communication by assessing access, transparency, responsiveness, and scalability. Use a framework to ensure your partner builds a strong relationship that endures through any challenge.

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

Building the right cleanroom involves critical early decisions. Review a methodical framework that ensures flexibility, compliance, and operational readiness from initial concept through delivery.

3D Screen Printing: Enabling A New Generation Of Complex Formulations

Screen-Printed Innovative Drug Technology can produce oral, transdermal, and implantable dosage forms while ensuring heterogeneous distribution of active ingredients.

Process Validation For Pharmaceutical Manufacturers

Manufacturers must validate their processes to meet FDA standards and protect consumer safety. Find out how process validation ensures consistent product quality and is a cornerstone of compliance.

Vials And Deep Cold Storage - Determining Mechanical And CCI Performance

Understand the implications of this study on the storage of sensitive molecules that require deep-cold storage and reveal how 2R Fina glass vials are poised to enhance cold storage practices.

Solving Delivery Challenges For Tolerogenic Vaccines

Uncover the advantages offered by an orally dissolving tablet platform relating to large molecule storage, aggregation, and, in some cases, protease activity.

Importance Of Modularity In Drug Manufacturing Aseptic Filling Systems

Learn about a flexible aseptic processing system that provides modular, semi-automated, and fully automated solutions to meet demands at all stages of development.

Recommended Mixing Equipment For Liquid Supplements

Explore the benefits of preparing liquid supplements in a multi-shaft mixer designed for bulk agitation, high-speed solids dispersion, and superior heat transfer.

The Digital Transformation Of A Leading CDMO's Process Development Lab

See how a leading CDMO was able to create a data model for its bioreactors, resulting in easily contextualized data, time savings in manual tasks, and the ability to share insights in real time.

FAT, SAT, IQ, OQ, SMEPAC - What Does It All Really Mean?

Gain insight into the proper timeline for process validation, the importance of linking the User Requirements Specification (URS) to each step of validation to ensure complete compliance, and more.

SPONSOR

Lessons Learned from FDA 483s and Warning Letters – Strengthening GMP Cleanroom Compliance in Life Sciences

Join AES Cleanroom Technology experts as they reveal critical lessons from FDA 483 observations and Warning Letters tied to GMP cleanrooms in the life sciences industry. Through real-world case studies and regulatory insights, attendees will learn how to prevent common compliance failures, strengthen contamination control, and design resilient, inspection-ready facilities aligned with cGMP requirements. Click here to learn more.

SOLUTIONS

The Cost Of Delaying Digital Validation

End-To-End Pharmaceutical Solutions With A Softgel Specialty

At-A-Glance Monitoring: Inside The TSI FMS Web Client Dashboard

Biological Indicators To Fit Your Needs

The Future Of GxP Manufacturing With AI

Leading Solutions For Air And Gas Monitoring

AI-Enabled Route Scouting Service

Robotic Fill-Finish Cell

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