Newsletter | October 31, 2024

10.31.24 -- When Should You Select Your Supply Partner?

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Now available on demand! Choosing the right CDMO for antibody development is crucial. The wrong partner can lead to delays and quality issues, while the right one can streamline development and improve commercialization success. Join Outsourced Pharma's expert panel on CDMO selection for biologic drug developers, where experts will discuss qualification processes, partnership management, team and facility compatibility, and how to leverage your CDMO's strategic expertise.

FEATURED EDITORIAL

When Should You Select Your Supply Partner?

In this part two, James Doherty, President and Chief Development Officer, provides readers with a window into the contracting strategy of Acumen Pharmaceuticals, a biotech developing a novel therapeutic for the treatment of Alzheimer’s disease (AD). Acumen has announced it entered a CDMO contract for both clinical and any future commercial supply.

The Regulatory Affairs Function Is Evolving. Are You Evolving With It?

The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.

INDUSTRY INSIGHTS

Quantitation Of Retrovirus-Like Particles (RVLPs) In CHO Derived Products

Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.

Commercial Vs. Technical Priorities: The PM High-Wire Act

Project managers (PMs) must be technically adept enough to understand a project, but their main role is to ensure it delivers in terms of scope and budget.

Advancing Aseptic Filling: Evaluating The Revolutionary SA25 Workcell

Examine how leveraging a fully robotic aseptic filling system enables versatility, high yields, and low losses, as well as precise and repeatable fill parameters batch to batch.

Nasal Vaccine Development, Manufacturing, And Device Selection

A partner experienced in development and manufacturing techniques, capable of guiding a nasal delivery program from small-scale clinical to commercial supply, is 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.

Advancing Biomanufacturing Excellence Through Artificial Intelligence

See how AI is transforming the biomanufacturing industry and how partnerships between pharmaceutical companies and academic institutions are poised to set the new standard.

Does Your Biologics CDMO Truly Have A Culture Of Quality?

Learn how to navigate the wide range of "quality claims" and find a CDMO partner that is committed to a culture of quality, placing safety and product excellence at the core of their operations.

Inclusion Bodies: Mother Nature's Help Or Hindrance?

Consider these strategies to improve the performance of IB processes as well as the pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding.

SOLUTIONS

Downstream Process Development

With insight gained from producing more than 200 biologics to date, we have established downstream platforms that allow us to move quickly into a product’s manufacturing phase.

Biologics Analytical Development

Leveraging robust analytical services at every stage of development and manufacturing is crucial to ensure your therapy reaches patients in need on time and within budget.

Mammalian Cell Culture: Process R&D Services

Discover how our specialized R&D and manufacturing services can support your product development needs at every stage by learning more about our cutting-edge solutions, here.

Handle Your Drug Product With The Highest Quality And Safety

Explore our fill line capabilities, including vial and syringe handling. Schedule an immersive tour of our drug product filling facility in Denmark. Our experienced team is available to discuss your needs.

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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