Newsletter | October 23, 2025

10.23.25 -- What To Prioritize When Selecting A Sterile Fill/Finish CDMO

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.

FOCUS ON OUTSOURCING

What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish

Choosing the right CDMO partner for a biotech product isn’t about “capacity at a good price”; it’s about a partner with the right mix of technical expertise, regulatory track record, and more.

Getting To The Heart Of CDMO Tech Transfer Excellence

Discover five key factors that drive a seamless and efficient technology transfer, highlighting how a culture of technical expertise, customer focus, and operational flexibility is crucial to success in the CDMO industry.

What's Driving The Future Of Biopharma And Outsourcing Strategies?

Review the rapidly evolving world of complex drug development and the critical factors that drive success for products made using different molecules beyond the traditional antibodies.

Visualizing Airflow With Smoke Studies For Aseptic Manufacturing Excellence

JHS uses smoke studies to visualize airflow in cleanrooms, ensuring aseptic conditions and regulatory compliance for sterile pharmaceutical production, especially on new aseptic filling lines.

Strategies For Transferring Potency Assays From Lab To GMP Production

With experience in managing assay transfers across diverse sources and development stages, we have identified five factors that can significantly impact the success of potency assay transfers.

Successful Completion Of The Project NaDiNa

Learn how a novel nanotechnology-based anticancer drug was successfully formulated, clinically batched under GMP, and prepared for Phase I trials.

Unlocking Potential: A Deep Dive Into AAV Development And Manufacturing

When it comes to furthering AAV's potential in the wider biopharmaceutical pipeline, partnering with a CDMO that can foment an optimal analytical and manufacturing strategy is crucial.

The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

Optimizing The Path To First-In-Human Clinical Trials: Design And De-Risk

Explore the ways to design and de-risk molecules, streamlining the path to GMP manufacturing and clinical trials, and case studies that provide insight into key activities.

Accelerated Tech Transfer With Integrated Project Management

Observe how integrated project management and co-located DS/DP operations streamline technology transfer, reduce risks, and accelerate biopharmaceutical development timelines.

Transforming Rare Disease Drug Development For A Faster Cure

This comprehensive exploration aims to shed light on the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey.

Single-Use Innovation For The Future Of Therapeutic Manufacturing

Gain insight into these end-to-end plasmid DNA solutions, leveraging robust cGMP-compliant processes and single-use manufacturing platforms to accelerate your cell and gene therapy programs.

SPONSOR

Webinar: Driving Robust Tech Transfer in Biologics: Computational Fluid Dynamics (CFD) Simulation

Biopharmaceutical scale-up success depends on understanding how process conditions impact product quality. Join Samsung Biologics to explore how Computational Fluid Dynamics (CFD) enhances Quality by Design by modeling key parameters like mixing, shear, and oxygen transfer. Learn how virtual experimentation accelerates tech transfer, strengthens process robustness, and drives smarter, risk-based decisions in bioprocess development. Click here to learn more.

OUTSOURCING SOLUTIONS

Deliver Cell Therapies Faster, More Reliably And Enhance Cell Properties - BlueWhale Bio

Quality Control Services - Argonaut Manufacturing Services

Manufacturing With Interconnected Modular Platform Technologies - Resilience US, Inc.

Integrated ADC Offering: From Concept To Commercialization - Lonza

Building The CDMO Of The Future - FUJIFILM Biotechnologies

Capacity Update April 2025: Large Molecule Development - Northway Biotech

Capacity Update April 2025: Fill/Finish - Catalent

Capacity Update July 2025: Large Molecule Drug Substance - Cytovance Biologics

SPONSOR

Sterile and Aseptic Sampling Solutions

NovaSeptum® Sterile Sampling Solutions: closed, plug-and-play systems for safe sampling throughout Single Use or Multi Use manufacturing. Representative sampling protects sample and process integrity. Design flexibility: standard or customized and multiple container options. Suitable for sterility, bioburden, mycoplasma, endotoxin or any other QC testing requirements. Learn more here.

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