R & D
R & D
R&D. Committed to delivering forward thinking and sustainable non-invasive delivery technologies.
Every day at LTS, our work is focused on the delivery of safe and innovative technologies, that are positively welcomed by patients and can be readily adopted by our pharma partners.
With extensive experience in this space, we know that APIs can present certain challenges, such as low bioavailability and GI-tract related side-effects. In response, we can work together with your API to develop formulations that have the desired characteristics in terms of stability and bioavailability. We will transform your formulations into effective and commercially viable therapies via alternative dosage forms, whether optimized for transdermal, topical, oral or nasal delivery.
Our staff of more than 150 product and technical development specialists are based at dedicated LTS R&D centers in Germany and the USA. They are organized into focused project teams with an average of 15+ years’ experience in the development of drug delivery formulations, and each with a multi-disciplinary skillset across analytics, excipients, formulation, skin permeation, and scale-up. These specialties support our capabilities in:
Feasibility studies
Formulation development
Stability testing
Clinical trial supply
Scale-up/process qualification
Nasal: LTS provides comprehensive end-to-end support for pharma partners capitalizing on the benefits of nasal drug delivery. Our recently expanded R&D laboratory in Lakewood, NJ, USA is complemented by a complete suite of clinical manufacturing services, enabling your project deadlines and development objectives to be met in full.
Our nasal services include:
Pre-formulation & formulation development
Analytical development and validation
Spray characterization method development and validation
Device selection
Process development and validation
Clinical trial material (CTM) manufacturing
Quality by Design (QbD) services
Lab scale / clinical trial material / scale-up support
On-site stability programs (ICH and custom)
Validation and regulatory support
Sterility testing
Reliability and in-vitro bioequivalence studies
Secondary packaging
Maintaining an excellent compliance record globally
The controlled-access areas within our R&D facilities feature formulation labs with specifically designed containments for handling high potency APIs, state-of-the-art analytical labs, and multiple walk-in stability chambers, including the infrastructure for controlled substances (DEA I-IV) handling. To facilitate fast, small-scale testing, we have developed a broad portfolio of transdermal, topical, nasal, oral film or microneedle formulation designs.
Clinical trial supplies and scale-up activities are conducted within our designated GMP area. When it comes to manufacture, the experience and expertise of our dedicated engineers ensure manufacturing equipment can be configured and customized to the individual needs of each specific client project.