Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.
Lonza Pharma & Biotech’s SimpliFiH Services takes an integrated approach to addressing bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.
According to the company, as drug discovery and development accelerate and solubility and dissolution rate challenges become more complex, new solutions are required to reduce the timeline from initial idea to a first-in-human clinical verification. Lonza’s new service package is suited for companies that have solubility-challenged molecules and require drug substance and drug product services for early-stage development and first-in-human studies. The company states that it has also developed streamlined service agreement templates specific to the SimpliFiH package to reduce time, cost, and complexity for these studies.
The company’s proprietary bioavailability enhancement technology selection methodology serves as the foundation of the services. This methodology consists of databases and models based on more than 25 years’ experience advancing thousands of molecules to Phase I across all key enabling technologies-particle size reduction, solid dispersions, and lipid-based formulations. By using this methodology, a single-enabling approach for early first-in-human studies can be rapidly identified without extensive solubility screening, which reduces early phase clinical timelines and API requirements, according to Lonza.
The services include key drug substance and drug product components required for first-in-human studies for small molecules: drug substance development and supply, solid-state characterization/bioavailability enhancement, and phase-appropriate drug product in powder-in-capsule, powder-in-bottle, liquid-filled hard capsule, or tablet format. Basic analytical services inclusive of stability studies are included in the service package. Regulatory services for supporting, consulting on, or writing investigational new drug and investigational medicinal product dossier applications are available to support first-in-human requirements.
Source: Lonza Pharma & Biotech
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.
Exosomes Field Advances with Milestones Achieved by EXO Biologics and ExoXpert
December 4th 2024EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.