Newsletter | March 10, 2025

03.10.25 -- 'Fractional Hiring' At Your CDMO. Okay With You?

SPONSOR

Webinar: Shifting the Future of Drug Development with Advanced Analytical Characterization

Understanding the structural properties and impurities of biotherapeutic molecules is crucial for regulatory submissions and product development. As biotherapeutics become more complex, new analytical challenges emerge. This webinar covers advanced tools like mass spectrometry, biophysical characterization, and high throughput analytics to ensure safe, compliant medicines. Click here to learn more.

INDUSTRY INSIGHTS

Pairing Robust Analytical Methods With Efficient Process Development

Analytical method development is a critical phase in development, and its successful implementation is essential for delivering high-quality products to market efficiently and effectively.

N-Glycan Characterization With LC-MS

Glycosylation, a prevalent modification of mAbs, significantly impacts their function. Delve into various techniques for analyzing released glycans and their relative efficacy in HILIC-FLR-MS.

Cell Line Development Screening: A Key Step For Yield And Quality

The selection of representative cell lines for expressing bispecific antibodies (BsAbs) is a crucial initial development stage that significantly influences overall process yield and quality.

A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS

Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.

Challenges And Solutions For Viral Product Development, Manufacturing

To execute complex viral product manufacturing, a service provider needs expertise in adherent cell culture capabilities, cell line productivity, and the intricacies associated with these products.

Avoiding The Pitfalls Of LNPs And Complex Formulations

Review the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.

Leveraging Novel Analytical Approaches For Advanced Therapies

Compare the advantages and limitations of transcriptional assays versus reporter gene assays and how the transcriptional assay compares to ddPCR and flow cytometry for analysis of CGTs.

The Increasing Demand For Sterile Filtration Of High Concentration Drugs

Based on the current trends and challenges with manufacturing high-concentration drug products, consider this approach to performing filterability trials without a high quantity of expensive products.

Wearable Injectors: An Alternative To Traditional Intravenous Administration

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

FEATURED EDITORIAL

'Fractional Hiring' At Your CDMO. Okay With You?

The biopharma industry needs a dynamic and flexible hiring marketplace — an ecosystem that boosts awareness among professionals and students about available opportunities. “It’s no longer just about posting full-time jobs,” says Chris Frew, founder and CEO of BioBuzz Networks. What about part-time roles at your CDMOs?

How To Optimize Downstream Separation With Tagless Proteins

The intein-based magnetic bead system enables effective affinity capture, tag removal, and buffer exchange, supporting direct analytical applications.

SPONSOR

Take a tour of Nanoform's best-in-class nanodevelopment capabilities, setting new standards in innovation. Their highly specialized team excels in creating unique nanoparticles for both small and large molecule APIs. With 14 development lines for small molecules and 5 for large molecules, Nanoform offers unmatched scalability and precision. Leveraging cutting-edge technology, they produce nanoformed materials as small as 10 nanometers. Learn more.

SOLUTIONS

Cleanroom Collaboration

Learn how INCOG BioPharma's speed and flexibility can help your organization with your drug product, from clinical to commercial, with our high-performing cleanroom facility and filling technology.

Quality Management System (QMS) For Drug Manufacturing

It's time to close the loop on quality — from quality event management to document management and training — and see how MasterControl quality management system can transform your business.

Package Design Development Services

Our pharmaceutical packaging design department provides insightful packaging design and practical knowledge to deliver differentiated and cost-effective packaging solutions.

Complex Chemistry For Antibody-Drug Conjugates And Beyond

With extensive experience, we deliver scalable, high-quality solutions for complex molecular constructs, ensuring efficient and safe production of advanced therapeutic modalities.

ATON Bio Capacity Update July 2024: Large Molecule Development

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

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.

Connect With Outsourced Pharma: