Newsletter | April 24, 2025

04.24.25 -- Pharmaceutical Sovereignty: The Resilience We Cannot Outsource

SPONSOR

Webinar: From Cell Line Development to Upstream Optimization: Enhancing Biologics Quality and Productivity

Join Samsung as they share how to enhance purity, stability, overall performance and further increase productivity by 2-fold while maintaining quality. In addition, learn how the S-AfuCHO™ cell line, developed from its proprietary S-CHOice® host cell, produces fucose-free antibodies with significantly enhanced ADCC activity, leading to more potent therapeutic effects. Click here to learn more.

FOCUS ON OUTSOURCING

Pharmaceutical Sovereignty: The Resilience We Cannot Outsource

By Ajaz S. Hussain, Ph.D.

Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration. 

Tips For Successfully Scaling From R&D To Manufacturing

Article | Cytovance Biologics

By partnering with a trusted company that offers expertise in navigating the challenges of scale up, drug developers can have confidence in their ability to successfully bring their products to market.

Seasonal Vaccine Manufacturing

White Paper | By Elizabeth Joseph, Simtra BioPharma Solutions

Explore how our contract manufacturing solutions can help you meet the growing demand for seasonal influenza vaccines efficiently and effectively.

Understanding Process Development Of Antibody-Drug Conjugates

e-book | By Reese Chung, Mycenax

Examine a platform process that is emerging as a simplified and reliable solution for ADC manufacturing, offering efficient process development, purification techniques, and optimization strategies.

Tech Transfer In Sterile Injectables: 3 Phases Of Success

Webinar | Pfizer CentreOne

Journey through the 3 phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.

Set Your Cell And Gene Therapy Program Up For Success From Day One

White Paper | Aldevron

Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.

Transforming Safety: A Customer Centric Model For Patients And Employees

Webinar | FUJIFILM Diosynth Biotechnologies

Learn about unique infrastructure around safety operations and quality, with a focus on a new product introduction process with respect to risk assessment.

SPONSOR

The biotechnology sector is transforming with AI, automation, and digitalization playing key roles in drug development and manufacturing. As the industry moves toward end-to-end digitalization, don't miss the opportunity to join the 2025 ISPE Biotechnology Conference, 2 – 3 June in Boston, Massachusetts, USA, and virtually, to gain a holistic perspective on how to view and apply digital transformation in biopharmaceutical manufacturing. Register today: visit ISPE.org/Bio25.

OUTSOURCING SOLUTIONS

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mAb/Recombinant Protein Lot Release Package - WuXi Advanced Therapies

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Argonaut Quality Control Services - Argonaut Manufacturing Services

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CDO Services: Agile. Flexible. Focused On You. - Samsung Biologics

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Mammalian Cell Culture: Process R&D Services - Lonza

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Biologics Discovery, Development, And Manufacturing - Curia

SPONSOR

Multispecific molecules bring added complexity to downstream purification—think incorrect chain pairings, aggregation, fragmentation, and lower yields. Join Bioprocess Online Live as we explore how developers are addressing these challenges to achieve high purity and efficient processes. Gain insights into key considerations for downstream teams when designing purification strategies for these advanced biologics. Registration is free thanks to the support of Thermo Fisher Scientific.

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