KelSie Biotech
KelSie Biotech is a biotechnology company headquartered in Boulder, CO, specializing in formulating and delivering sensitive Active Pharmaceutical Ingredients (APIs) through its patented CAN-BD process. The company focuses on innovative drug delivery systems including inhalable powders, sublingual wafers, nasal sprays, and topical formulations, aiming to improve bioavailability, stability, and targeted delivery of pharmaceuticals. KelSie collaborates with academic, research, and commercial entities to develop and commercialize advanced pharmaceutical products, leveraging its expertise in formulation, testing, licensing, trial design, and manufacturing.
Industries
Nr. of Employees
small (1-50)
Products
Dry powder inhalable formulations
Stable dry powder formulations engineered for pulmonary delivery with controlled particle morphology and aerodynamic size for deep lung uptake, intended as needle-free alternatives to injectables.
Sublingual wafers and buccal dissolvable formulations
Powder-processed wafers and tablets formulated to dissolve under the tongue or buccal mucosa to enable direct systemic absorption and reduce first-pass hepatic metabolism.
Nasal powder formulations
Powder formulations optimized for nasal mucosa delivery to support assisted delivery for children, elderly or patients with compromised lung capacity.
Topical powder formulations
Formulations designed for topical application to promote rapid local absorption or treat surface wounds and lacerations.
Device-compatible powder product prototypes
Pre-formulation and prototype powders tailored for compatibility with single-dose DPIs, multi-dose blister DPIs and pressurized metered-dose inhalers to ensure consistent metering and dispersibility.
Dry powder inhalable formulations
Stable dry powder formulations engineered for pulmonary delivery with controlled particle morphology and aerodynamic size for deep lung uptake, intended as needle-free alternatives to injectables.
Sublingual wafers and buccal dissolvable formulations
Powder-processed wafers and tablets formulated to dissolve under the tongue or buccal mucosa to enable direct systemic absorption and reduce first-pass hepatic metabolism.
Nasal powder formulations
Powder formulations optimized for nasal mucosa delivery to support assisted delivery for children, elderly or patients with compromised lung capacity.
Topical powder formulations
Formulations designed for topical application to promote rapid local absorption or treat surface wounds and lacerations.
Device-compatible powder product prototypes
Pre-formulation and prototype powders tailored for compatibility with single-dose DPIs, multi-dose blister DPIs and pressurized metered-dose inhalers to ensure consistent metering and dispersibility.
Services
Formulation services
Development of dry powder formulations for APIs and biologics including excipient selection, stability optimization, particle engineering and delivery-site targeting for inhalation, sublingual and topical use.
Analytical and testing services
Provision of analytical testing and characterization including qNMR, HPLC, GC, ICP-MS, SEM, Karl Fischer titration, microbial and stability testing, emitted dose measurement, and respirable fraction determination by cascade impactor.
Licensing and collaborative R&D
Engagement in collaborative R&D and licensing, including joint ventures and sub-licensing of formulation and bubble-drying process technology in defined fields of interest.
Clinical trial design and support
Design and implementation support for pre-clinical and clinical studies focused on delivery and bioavailability of particulate formulations, including IRB support, recruitment, demographic analysis and in-house QA/analytics.
Engineering and manufacturing consulting
Engineering services including CAD, CFD evaluation, GMP equipment design, HMI implementation, process optimization, cyclone design, powder collection customization and delivery device design/testing.
Formulation and process consulting
Remote and on-site consulting covering formulation design and feasibility, testing, SOP auditing, process viability testing, cascade impactor testing, device compatibility and process/productivity improvements.
Formulation services
Development of dry powder formulations for APIs and biologics including excipient selection, stability optimization, particle engineering and delivery-site targeting for inhalation, sublingual and topical use.
Analytical and testing services
Provision of analytical testing and characterization including qNMR, HPLC, GC, ICP-MS, SEM, Karl Fischer titration, microbial and stability testing, emitted dose measurement, and respirable fraction determination by cascade impactor.
Licensing and collaborative R&D
Engagement in collaborative R&D and licensing, including joint ventures and sub-licensing of formulation and bubble-drying process technology in defined fields of interest.
Clinical trial design and support
Design and implementation support for pre-clinical and clinical studies focused on delivery and bioavailability of particulate formulations, including IRB support, recruitment, demographic analysis and in-house QA/analytics.
Engineering and manufacturing consulting
Engineering services including CAD, CFD evaluation, GMP equipment design, HMI implementation, process optimization, cyclone design, powder collection customization and delivery device design/testing.
Formulation and process consulting
Remote and on-site consulting covering formulation design and feasibility, testing, SOP auditing, process viability testing, cascade impactor testing, device compatibility and process/productivity improvements.
Expertise Areas
- Dry powder formulation development
- Inhalation and mucosal delivery
- Particle engineering for pulmonary delivery
- Analytical characterization of inhalable products
Key Technologies
- CO2-assisted nebulization with bubble drying (supercritical fluid nebulization and bubble drying)
- Dry powder inhalation formulations
- Sublingual wafer formulation
- Particle size control (10 nm–20 µm; target 1–5 µm respirable range)