Newsletter | June 18, 2024

06.18.24 -- ADCs Ignited With Daiichi Sankyo Inc.'s Ken Keller

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Webinar: AAV Transient Transfection and Producer Cell Line Platforms to Accelerate your Path to IND

Learn about two exciting, high-performing AAV manufacturing platforms, using transient transfection and stable producer cell lines (PCL) technologies to address common challenges with productivity, scalability, cost, supply chain and batch-to-batch variation. Together, our AAV platforms can enable high quantity and quality of commercial AAV manufacturing at needed scale for your valuable therapies. Click here to learn more.

FOCUS ON OUTSOURCING

ADCs Ignited With Daiichi Sankyo Inc.'s Ken Keller

Just a few years ago, Daiichi Sankyo wasn't considered a player in the oncology therapeutics space, and it certainly wasn't a player in ADCs. But then, just a few years ago, who was? Fast forward to 2023, and we see an ADC arena that drove nearly $100 billion in M&A, licensing, and partnership deals, and a Daiichi Sankyo that can rightfully lay claim to lighting that fire.

Protecting Your Intellectual Property Rights In Drug Manufacturing

Being aware and proactive in addressing IP risks and challenges, especially for drug developers and sponsors operating in Asia, is critical. Delve into the IP landscape of several Asian countries.

Realizing A New Approach To Allogeneic Cell Therapy Process Development

Increased investment in allogeneic therapies and process-level advancements to achieve commercial scale are paving the way for streamlined, standardized cell therapy development and manufacturing.

What Are The Five 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.

Current And Emerging Technologies To Optimize mRNA Manufacturing

Explore the benefits of using mRNA for vaccines and therapeutics, and learn how to address technical, intellectual property, and cost considerations when considering commercial production.

Navigate The Evolving Antibody Therapeutic Landscape

There are several important factors that developers and manufacturers will need to consider to effectively support antibody therapeutics and navigate the trends and challenges on the horizon.

Biopharma Tech Transfer: Facility Fit And Process Gap Assessments

Biopharmaceutical tech transfer, critical to the successful development and manufacture of an asset, requires careful planning and evaluation to meet project timelines for scale up and GMP.

Avoid Clinical Manufacturing Pitfalls With These Tech Transfer Best Practices

Ensure a smooth transition from development to manufacturing by implementing a strategic tech transfer process. Review key practices for effective communication, collaboration, and risk mitigation.

Buffer And Process Liquid Considerations For Scale-Up And Outsourcing

For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce risk.

CRISPR Gene Editing, CDMOs, And The Art Of "Just Right"

Learn how finding the right combination of capabilities and expertise in a CDMO can set you up for success and keep your innovative project on time and within budget.

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A ballooning clinical-stage ADC development community is putting stress on both manufacturing capacity and antibody engineering and conjugation talent. What does this burgeon mean for ADC manufacturing, process development, and, ultimately, clinical progress? Join Bioprocess Online Live on July 9th as we navigate the complexity of the ADC manufacturing environment. From linkers to payloads to conjugation, we’ll cover the lay of the land for developers. Registration is free thanks to the support of Cytiva.

OUTSOURCING SOLUTIONS

Looking For Scalability In Clinical Manufacturing? - Andelyn Biosciences

UpTempo AAV Platform Process - Catalent

Antibody Discovery & Engineering Services - Curia

Induced Pluripotent Stem Cells - ElevateBio

Surfactant Analysis Services - Lonza

GMP Manufacturing - Nanoform

Propel Your Biologics Program - Resilience US, Inc.

Capacity Update February 2024: Large Molecule - Simtra BioPharma Solutions

Codex HiCap RNA Polymerase - Aldevron

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