Newsletter | October 7, 2024

10.07.24 -- Outsourced Complex Protein Development Demands Special Considerations

SPONSOR

Breaking Barriers: Combining Cell Line Development Innovation with Improved Process Development Workflows to Streamline Path to FIH

This webinar will focus on how KBI Biopharma's SUREtechnology Platform™, powered by Selexis®, enables rapid advancement of new complex biologics from early development to first-in-human (FIH). Register to learn how the integration of the SUREtechnology Platform™ accelerates the creation of high-performing, stable cell lines tailored for biologics production. Learn more here.

FEATURED EDITORIAL

Outsourced Complex Protein Development Demands Special Considerations

Complex protein therapeutic innovators are often orchestrating the work of three, four, or more outsourced manufacturing partners at once. What goes into their selection criteria? Experts from ADC and fusion protein sponsors weigh in, with bonus commentary from a CDMO process development specialist.

Team Topologies For Outsourced CMC Development

When functions such as analytics or formulation get outsourced, team dynamics must adapt to ensure cohesive integration and effective communication.

INDUSTRY INSIGHTS

Pairing Robust Analytical Methods With Efficient Process Development

Analytical Method Development is a critical phase in development, and its implementation is essential for delivering high-quality products to market efficiently and effectively.

How Are Vaccines Tested?

Testing vaccines is a rigorous multi-stage process. From initial lab research to human trials and regulatory approval, discover how vaccines undergo scrutiny to protect public health.

An Experienced CDMO Can Be A Differentiator In The Biologics Market

Discover how an experienced CDMO offering a purpose-built facility with flexible capacity can help biopharmaceutical companies bring their products to market quickly and efficiently.

The Right Partnerships Are Key To Harnessing New Sterile Delivery Methods

By leveraging the expertise of CDMOs, pharmaceutical firms can expedite their time to market, reduce costs, and improve patient outcomes, advancing the future of drug delivery methods.

Drug Product Process Characterization For Liquid And Lyophilized DP

Explore important initial steps to consider and implement during the process design phase which is a pre-requisite to a successful PPQ campaign and readiness for commercial manufacturing.

Autoinjectors: A Revolutionary Leap In Drug Delivery

Explore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.

Developability Assessment Of Three Therapeutic Antibodies

This poster reviews studies for three monoclonal antibody drug candidates utilizing a panel of small scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability.

Tech Transfer To Validation: A Client-Centric Approach To Development

If you’re looking to work with a CDMO that can help you save money and ensure efficiency in your therapeutic production, consider the benefits of choosing a Polish partner.

Simplifying Outsourcing For Complex Formulations

Uncover the necessary components of a tech transfer for LNP-based drugs, including the outsourcing strategies needed to avoid pitfalls.

The Scalability Of Depth Filters For CHO Cell Culture Clarification

Clarification using depth filtration is standard in monoclonal antibody (mAb) manufacturing. Here, we showcase the scalability of Stax™ mAx depth filters, demonstrating their effectiveness.

SPONSOR

Join the next Outsourced Pharma Live as our panel explores the critical considerations and best practices for selecting and managing CDMOs in the development of novel therapies, including advanced therapy medicinal products like cell and gene therapies. Industry experts will share insights on evaluating CDMO capabilities, ensuring quality and compliance, and fostering effective partnerships to accelerate innovation while mitigating risks.

SOLUTIONS

Enabling The Delivery Of Complex Biologics With Ergonomic Solutions

The BD UltraSafe Plus passive needle guard for pre-filled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility.

Biologics Manufacturing

Our multi-product manufacturing facilities feature state-of-the-art equipment for animal cell-derived viral and microbial products for your clinical trials, following cGMP guidelines.

Simplify Your Linker-Payload Synthesis

By streamlining the synthesis pathways, see how these products can effectively diminish the requisite number of developmental and manufacturing stages essential for generating payloads.

Testing Solutions For Antibody-Based Products

Our suite of analytical testing services for antibody-based drugs encompasses feasibility studies, method development, validation, routine testing, and stability assessments.

Plant 5 — Dream Plant: Within Your Reach. Built For Your Success.

Finding a CDMO committed to increasing capacity and optimizing processes with innovative technologies is key to adding efficiency while maintaining high quality standards.

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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