Digital Library
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Poster: Discover the importance of an appropriate linker and the need for thorough product characterization in order to understand the structure-function relationships of an ADC.
Application Note: Evaluate the physical compatibility and extractable results of a proposed single-use solution for conjugation, purification and sterile filtration for ADCs.
White Paper: Explore best practices for ensuring a seamless transition of API raw material supply at critical junctions on the path from preclinical development to commercial manufacturing of small molecule drugs.
White Paper: Discover the most important aspects to consider for lipid-based formulations, strategies in drug development of RNA therapeutics as well as raw material selection.
White Paper: Learn three techniques for modifying the physical state of APIs with the aim of enhancing solubility by converting the poorly soluble drug from its crystalline form into a stabilized amorphous structure.
White Paper: Discover the relevant laws and guidelines, as well as voluntary standards developed by the industry to foster implementation.
Poster: See how to establish a flexible formulation platform for PVA based coatings and to apply novel analytical technologies to improve the performance of the coating system in early stages of development.
Webinar Library
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Learn how the single-use technology vendor and the ADC manufacturer play a role in designing, qualifying, and implementing fit-to-purpose single-use equipment, flowpaths, and processes to deliver consistent and scalable ADC chemistry and functionality with desired final product specifications and high yield. (45:53)
Hear the story of a CMO preparing for the manufacture of a Commercial Antibody Drug Conjugate (ADC). Learn how to properly structure your development work, perform a thorough process risk assessment, prepare for pre-approval inspection. (53:37)
Learn more about the types of PEGs that are used in ADCs and find examples of successful implementation to change the biophysical properties of the construct. Explore why activated PEGs are widely used to improve the pharmacokinetics of drugs. (41:27)
Hear from our experts how amorphous stability from a theoretical perspective in the context of polymeric solid dispersions and mesoporous silica formulations. This recent data demonstrates the potential of mesoporous silica for superior amorphous stabilization of poor glass formers. (48:30)
Explore the benefits of adding excipients during downstream processing on protein stability, chromatographic performance and viral inactivation. (52:09)
Learn more about advantages of the SynBiosys® polymer based sustained release microparticle technology platform. (48:55)
Learn more about amorphous solid dispersions and their preparation by hot melt extrusion. Explore how to identify the right polymer at early development stages and how to improve the performance of your formulation by using polyvinyl alcohol. (53:54)
Learn more about the root causes that led to Nitrosamine contaminations in APIs and various potential sources for nitrosamine formation and/or introduction, approach for nitrosamine risk assessment for pharmaceutical starting materials. (1:06:56)
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