Newsletter | February 20, 2025

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

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Are you attending World ADC London this year? On March 4th, don't miss our presentation on "Technical Excellence in Development and Manufacturing of Bioconjugates". Visit booth #10 to meet our team and discover how we can accelerate your ADC, bioconjugate, or small molecule conjugate program. Request a meeting to discuss your needs with our experts and discover how we can support you with our 15+ years of experience and leading expertise in contract development and manufacturing.

FEATURED EDITORIAL

They Said What? Unexpected Insights Into CDMO Selection

An assortment of conversations with experienced biopharma executives have generated some surprising commentary about CDMO selection. Here, I put those insights together, which include selection preparation/responsibilities, and some interesting CDMO behaviors of late.

Emerging Trends In mAbs Manufacturing In 2025 And Beyond

Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing.

INDUSTRY INSIGHTS

Effective Process Validation Accelerates Your Drug To Market

Discover how building a product development program with a long-term vision and adopting a holistic PPQ and CPV strategy from the outset are now crucial.

Plan Your CDMO Search On A Foundation For Long-Term Success

Capacity constraints typically are accompanied by other challenges, including missed timelines, defect rates, and overall decreased satisfaction with pharma companies’ bioprocessing CDMOs.

Regulatory Considerations For First-Time Drug Developers

Navigate the challenging path from concept to clinical reality by partnering with an experienced CDMO that can provide the expertise needed to move your therapeutic forward.

Application Of Plant And Process Models

Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.

Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions

This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

Analytical Strategies For The Biologics Development Life Cycle

A miscalculated analytical approach can be costly to develop, perform, and maintain. Many organizations also lack appropriate resources to create optimal testing methods and protocols.

Overcoming The Challenges In Fabs And Fc-Fusion Development Programs

Consider an integrated drug substance and drug product CMC strategy, along with technical case studies from process and analytical development that provide insight into tailored product-specific solutions.

Hosts For Vaccine And Virus Expression: Insect Cell Expression Systems

Choosing the right host is key to creating reliable commercial processes. Review common challenges associated with the insect cell culture/baculovirus expression vector systems platform.

Why A Leading Manufacturing Partner Chose NeoTOP Packaging Machines

Learn how a leading CDMO partnered with Körber to quickly deploy a high-speed packaging solution to meet tight production deadlines in the face of a global pandemic.

The Critical Role Of Comparative Analytical Assessments

Utilizing expert analytical testing services can unlock the potential of biosimilars and bring cost-effective treatments to market faster.

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Webinar: Get $mart: 1 Year Out from Phase 1 Injectable Trials, Avoid 3 Expensive Mistakes

Join us on March 6th with Singota to explore strategies for scaling up drug development from bench to Phase 1 clinical trials. Learn how to navigate cold chain logistics, develop robust analytical methods, and avoid compromising your core values. Discover insights from Singota’s 20+ years of experience helping early-stage biopharma teams succeed. Click here to learn more.

SOLUTIONS

Contract Manufacturing Success Story: Mapping Catheter

This flyer explains the challenges SMC Ltd. was presented with when they partnered with an OEM to create an intricate atrial fibrillation vascular catheter.

Aseptic Fill Finish Services To Support Your Success

Our comprehensive inspection systems, designed to adhere to the strictest regulatory standards, offer robust quality assurance, safeguarding the integrity of your product from development through to market.

Bioengineering Solutions Using A Fully Integrated Ecosystem

Find solutions to meet your gene, protein, antibody, or cell line needs using two gene synthesis platforms that enable the design of constructs optimized for maximal expression/yield in your system.

PCI Pharma Services ESG Report

Review PCI's commitment to environmental and social responsibility, including its ambitious sustainability goals and achievements across various categories.

Flexible Manufacturing Solutions, Services To Meet Evolving Industry Needs

Take a look at our full range of support services to streamline manufacturing processes through to commercialization of aseptic and lyophilized products.

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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