09.05.24 -- The High Life And Times Of A Qualified Person (QP) In Europe

Many issues can trip up a tech transfer process. Here are nine of them— plus ways to mitigate each one.

What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships?

Discover how whether you’re trying to achieve speed and cost-effectiveness or higher yields and glycosylation capabilities, the right system can be tailored to meet the needs of each unique biologic.

Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.

Explore how an integrated CLD approach, combined with cutting-edge technologies, can drive program success and accelerate the development of protein-based therapeutics.

Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design.

Cell-based assays are challenging due to inherent biological variation present in the starting materials. Explore the development of a cell-based potency assay implemented on an automated platform.

A strategy of building a global network of modular-designed large-scale and single-use facilities enables customers to rapidly ramp up production and transfer processes.

Recognizing what it takes to complete technology transfers effectively and efficiently is crucial to selecting the best partner for your project and product needs.

Innovative, flexible platform technologies drive next-gen bioprocessing efficiencies. Learn how advanced analytics enhance product characterization and support process optimization and regulatory requirements.

An experienced contract manufacturer can help developers to better utilize internal resources, leverage industry experience, and mitigate risk across development cycles.

This series addresses challenges in developing advanced biologics, focusing on CMC development, product purity, comparability studies, and manufacturing of antibody-drug conjugates. It offers guidance on biologics process development, characterization, and formulation, especially for high-concentration subcutaneous products, while aiming to enhance development and commercialization practices. Click here to learn more.

BD Neopak XtraFlow Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.

GS Effex has been engineered to lack the enzyme responsible for the addition of fucose, α1,6-fucosyltransferase. This cell line produces antibodies free of fucose.

Isolator technology can run continuously over several days, minimizing operator interaction and other opportunities to introduce contamination — ideal for high-volume, time-limited production runs.

We provide client-oriented contract development and manufacturing services for biologics, especially monoclonal antibodies and biosimilars.

Explore our installations in upstream development, bioreactors, and fill-finish. This state of the art EU-GMP facility is staffed by 250 professionals, and capacity is now available.