Newsletter | December 5, 2024

12.05.24 -- One Percent Of A Hundred People's Efforts

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Break Down Roadblocks To Commercial Manufacturing Success

Selection and implementation of a commercial manufacturing strategy is among the most critical decisions a biopharmaceutical company will make. Rely on an experienced CDMO partner with the ability to maximize the quality and cost-effectiveness of your antibody process at commercial scale. Explore key considerations for process optimization and process validation here.

FEATURED EDITORIAL

One Percent Of A Hundred People's Efforts

Persephoni BioPartners CEO Hilary Shultz, and newly hired Chief Scientific Officer William Heath – a 34-year veteran of Eli Lilly – explain their biotech-forming business model, dubbed a venture studio, and provide sound advice on working with CDMOs.

Should We Explore Suicidality In Animals During Preclinical Drug Development?

An adverse side effect for some drugs is suicidal ideation and behavior (SIB). Investigating SIB in animal studies represents the closest approximation to human SIB, yet the FDA Modernization Act 3.0 obligates us to reduce unnecessary animal testing. Let's examine this with data-driven research.

INDUSTRY INSIGHTS

A Tale Of Two Brothers: The Abpro Founders

By founding their latest venture, Abpro, Ian and Eugene Chan are using their synergistic skillsets in business and medicine to rapidly generate antibodies that treat cancer and autoimmune diseases.

The BIOSECURE Act: Implications For US-Based Biopharmaceutical Companies

Uncover the implications of the BIOSECURE Act and how US-based pharmaceutical companies and CDMOs are adapting to the new legislative landscape in order to remain competitive.

What Are The 5 Key Differences Between A Good CDMO And A Great One?

Market dynamics will continue to favor engaging with CDMO partners who have the capabilities and experience to manage short-term needs while anticipating and planning for long-term requirements.

Decoding A B-Cell Fingerprint: All You Need To Know

Explore how, much like a fingerprint, each B-cell possesses a unique identity, and how deciphering this code can unlock a wealth of possibilities in antibody development, immunotherapy, and beyond.

Reducing ADC Timelines With Integrated Development And Manufacturing

ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.

Vial Fogging: Practical Considerations For Vial Selection

Vial fogging is a common phenomenon observed in lyophilized biologic drug products. Here, we present two case studies that explore factors contributing to vial fogging and inform vial selection decisions.

A Deep Dive Into Expression Approaches For Biotherapeutics

Whether you’re at the discovery stage or thinking about commercial production, gain useful insights on expression formats from transient transfection, through stable pools to stable clones.

Assessing A Targeted Molecular Method Against Traditional In Vitro Testing

Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

How Outsourcing RNA-LNP Production Can Have A Competitive Advantage

Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.

Identify The Production Strategy Best Suited For Your Protein Or Peptide

Depending on the protein or peptide of interest for your therapeutic and manufacturing goals, there are a number of different approaches that can prove advantageous. Learn more about these various methods.

Standardizing Process Characterization And Late Phase Development

Consider this approach for process characterization to produce a monoclonal antibody, specifically at the drug substance biomanufacturing step, to improve efficiency and effectiveness.

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In this evolving environment, small to midsize companies without in-house capabilities, expertise and/or equipment are scrutinizing their pick of partners in pursuit of turnkey solutions. Companies are moving away from transactional approaches to more transformational partnerships that help them manage their fast-evolving pipelines and over-capacity scenarios. Now more than ever, companies need an integrated, start-to-finish development and manufacturing partner to help them get to the clinic with more speed and less complexity. Learn more now.

SOLUTIONS

Capacity Update October 2024: ADC

Leverage our integrated CRO and CDMO services for the development and manufacturing of complex biologics, bioconjugates, and ADCs, ensuring high-quality products and data packages.

Capacity Update October 2024: Large Molecule Drug Substance

Gain valuable insights into our mammalian development services, manufacturing solutions, upcoming capacity availability, as well as updates on expansion timelines for external clients.

Integrated Biotech Services: From Strain To Commercial Product

With over 30 years of expertise in biological processing and a proven track record in the chemical and biotechnological industries, we provide customers with a "one-stop-shop" service.

Testing Solutions For Biosimilars

Our scientists offer insights into physicochemical and structural properties, including post-translational modifications, through a range of assays.

Capacity Update October 2024: ADC

Partner with us for full-service ADC development and production, from feasibility to GMP manufacturing, with industry-leading standards and flexible capacities.

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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