Newsletter | March 13, 2025

03.13.25 -- Challenges And Opportunities Of Outsourcing Biopharma Development

SPONSOR

Webinar: Rapid Delivery of Toxicological Study Material: The new critical path for accelerating biopharmaceutical drug development.

With ever increasing speed from DNA to IND, the window for toxicological data generation is becoming shorter and more critical. In this webinar we explore the key strategies and technologies designed to address the analytical considerations and material flows to facilitate the rapid delivery of toxicological material. Click here to learn more.

FOCUS ON OUTSOURCING

Challenges And Opportunities Of Outsourcing Biopharma Development

By Williams Olughu, Ph.D., Ipsen

Oversight, knowledge management, and operational/compliance risk make up the three key challenge classifications to consider when approaching a new outsourcing agreement.

Tech Transfer: 7 Unique Challenges For Advanced Therapeutics

Article | WuXi Advanced Therapies

Ensure the success of your tech transfer by addressing these key challenges and optimizing your processes for seamless scalability and compliance.

De-Risk And Streamline Your Drug Substance & Drug Product Testing

White Paper | Labcorp Biopharmaceutical CMC Services

The key to navigating the biologic development journey lies in CMC. By analyzing and characterizing the drug's properties, CMC teams ensure a smooth path from bench to patient care.

Expanding The Boundaries Of Sub-Cutaneous Injections

Article | By Ahmed Besheer, Lonza

As the field of biologics increases its focus on identifying new diseases to target and novel constructs to treat them, innovative administration devices are once again in the spotlight.

Overcoming HCP Co-Elution Issues Using Cell Line Engineering

Case Study | AGC Biologics

Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

Why A CDMO In Poland Might Be Your Secret Weapon

Article | By Nigel Stapleton and Slawomir Jaros, Mabion

The current geopolitical climate is leading drug developers to consider global manufacturing partnerships strategically. Identify a CDMO partner that will help protect your IP, save money, and mitigate risk.

A Robust And Scalable Suspension Platform For AAV Manufacturing

Webinar | Andelyn Biosciences

Review the demands for AAV manufacturing using a suspension process and the DOE-based strategy used to achieve a scalable process both in terms production and quality of AAV purified.

SPONSOR

The rapid advance of ADCs has tested the fine balance between speed to IND and process development that stands up to the rigors of scale-up and transfer. Explore the processes leading ADC developers are employing to mitigate manufacturing-scale risk, and how automation and artificial intelligence are beginning to inform their work. Join Bioprocess Online Live for this interactive discussion. Registration is free thanks to the support of Thermo Fisher Scientific.

OUTSOURCING SOLUTIONS

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Our Capabilities - VintaBio

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Pionyr: Selecting A CDMO To Scale-Up Manufacturing - Lonza

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Boehringer Ingelheim BIOXCELLENCE - Boehringer Ingelheim Biopharmaceuticals GmbH

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Capacity Update January 2025: Large Molecule Development - Cytovance Biologics

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Capacity Update January 2025: Large Molecule Development - KBI Biopharma

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