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The Next Leap in Bioconjugate Development...

Bioconjugates pose complex development and manufacturing challenges. This brochure describes Lonza's manufacturing capabilities and the advantages of its simplified supply chain in which intermediates and the drug substance are manufactured under one quality system, reducing risk and accelerating the timeline to clinical trials and market. To learn more, please see our brochure.
Publish Date: 03-Feb-2020

Improving Solubility of Cannabinoids

As more cannabinoid-based pharmaceuticals are approved worldwide, interest is increasing in addressing the formulation challenges cannabinoid derivatives pose. In this Pharmaceutical Technology interview, Alyn McNaughton, technical director at Lonza, discusses common cannabinoid formulation and development issues , as well as potential solutions to those challenges. To learn more, please read this interview.
Authors: Dr. Alyn McNaughton
Publish Date: 02-Feb-2020

Selection of In Vivo Predictive Dissolution Media Using Drug Substance and Physiological Properties

The rate and extent of drug dissolution in the gastrointestinal (GI) tract are highly dependent upon drug physicochemical properties and GI fluid properties. Biorelevant dissolution media (BDM), which aim to facilitate in vitro prediction of in vivo dissolution performance, have evolved with our understanding of GI physiology. To learn more, please read our publication.
Authors: Dr. Deanna Mudie
Publish Date: 27-Jan-2020

Addressing Complexity in ADC Production

Maurits Janssen, Head of Commercial Development, API, and Bernhard Stump, Head of Process Development, Bioconjugates, write about the advanced capabilities needed to handle, formulate and scale antibody-drug conjugates (ADCs), as well as the benefits of partnering with an external CDMO.
Authors: Dr. Maurits Janssen, Dr. Bernhard Stump
Publish Date: 24-Jan-2020

A Mechanistic Physiologically-Based Biopharmaceutics Modeling Approach to Assess the In Vivo Performance of an Orally Administered Drug Product: From IVIVC to IVIVP

The application of in silico modeling to predict the in vivo outcome of an oral drug product is gaining a lot of interest. Fully relying on these models as a surrogate tool requires continuous optimization and validation. Establishing the link between biopredictive in vitro dissolution testing and mechanistic oral absorption modeling (i.e., physiologically-based biopharmaceutics modeling (PBBM)) creates an opportunity to potentially request biowaivers in the near future for orally administered drug products, regardless of its classification according to the Biopharmaceutics Classification System (BCS). To learn more, please view our publication.
Authors: Dr. Deanna Mudie
Publish Date: 17-Jan-2020

Effect of Spray-Dried Particle Morphology on Mechanical and Flow Properties of Felodipine in PVP VA Amorphous Solid Dispersions

Although amorphous solid dispersions (ASDs) successfully increase bioavailability, they can result in high tablet masses. This paper describes work to reduce the tablet mass of an ASD prepared from a low-Tg, rapidly crystallizing compound. Two polymers were strategically combined to prepare a high-drug-loading ASD tablet with a 40% lower tablet mass. The tablet had similar physical stability and in vitro performance as the benchmark and exhibited excellent downstream manufacturability. To learn more, please see our publication.
Authors: Dr. Alyssa Ekdahl, Dr. Deanna Mudie, Dr. David Malewski, Dr. Gregory Amidon, Dr. Aaron Goodwin
Publish Date: 12-Jan-2020

A Novel Architecture for Achieving High Drug Loading in Amorphous Spray-Dried Dispersion Tablets

Although amorphous solid dispersions (ASDs) effectively increase bioavailability, tablet mass can be high due to the large fraction of excipients needed. This publication describes work to reduce the mass of an ASD tablet made from rapidly crystallizing drug with a low glass-transition temperature (Tg). A high-loaded dosage form (HLDF), made by strategically combining two polymers within the tablet, was used to reduce tablet mass by 40%. The resulting formulation had similar physical stability and in vitro performance as the benchmark formulation and exhibited excellent downstream manufacturability. To learn more, please read our publication.
Authors: Dr. Deanna Mudie, Stephanie Buchanan, Aaron Stewart, Adam Smith, Dr. Kimberly Shepard, Nishant Biswas, Derrick Marshall, Dr. Alyssa Ekdahl, Amanda Pluntze, Christopher Craig, Dr. Michael Morgen, John Baumann, Dr. David Vodak
Publish Date: 12-Jan-2020

Requirements for Fully Integrated Offerings in a HPAPI and Cytotoxic Environment

The development of drug products based on potent compounds can be challenging, plus complications with the interface between operations in drug substance and drug product handling can result in increased program complexity and cost. This presentation describes best practices and infrastructure requirements that facilitate accelerated timelines to clinic and market. Topics include containment requirements, the impact of integrated service offerings on expansion strategies, and a case study of the development and commercialization of a highly potent drug substance. To learn more about this presentation, please view the summary.
Authors: Dr. Maurits Janssen
Publish Date: 18-Dec-2019

SimpliFIH® Solutions: Integrated Approach To First-in-Human for Bioavailability-Challenged Molecules

Oral administration of small molecules has become increasingly difficult because most new candidates demonstrate poor aqueous solubility. The bioavailability hurdle is made more challenging with the accelerated timelines, limited drug substance availability, and financial restrictions. This presentation discusses a proven model-based technology-selection methodology for poorly soluble molecules and an integrated formulation approach to minimize first-in-human (FIH) timelines. The role of API development and supply, solid state characterization, micro-dosing and encapsulation best practices for FIH studies is also be discussed along with representative case studies. To learn more, please watch our webinar.
Authors: Ben Sahacic
Publish Date: 24-Nov-2019

Practical Approach to Modeling the Impact of Amorphous Drug Nanoparticles on the Oral Absorption of Poorly Soluble Drugs

This paper describes a study that evaluated the mechanisms by which drug nanoparticles may enhance bioavailability by acting as  "shuttles" for drug across the unstirred water layer (UWL). Using three case studies, the nanomodified permeability method proved to be a suitable, fit-for-purpose in silico approach for evaluating or predicting oral absorption of poorly soluble, UWL-limited drugs from formulations that produce a significant number of amorphous drug nanoparticles. To learn more, please read our publication.
Authors: Dr. Aaron Stewart, Dr. Michael Grass
Publish Date: 19-Nov-2019