PRODUCTS & SERVICES

FORMULATION SERVICES

 

KelSie specializes in dry powder Formulation development, which encompasses processes that incorporate an Active Pharmaceutical Ingredient (API) into a drug product.  While biological activity is a prerequisite for a successful dosage form, it is not the sole determinant.  Factors such as stability, processibility, delivery, and availability to the target organ contribute to an efficacious pharmaceutical system.  

 
The following is a brief description of the key critical factors, which KelSie considers during formulation:

 

  • Stability: A common concern when considering the option to reformulate an active ingredient into a dry powder is the likelihood of degradation.  In order to stabilize the active ingredients and assist in achieving the optimum properties, additives known as excipients are commonly introduced. These excipients improve the physical or chemical stability of the formulation, and function as a carrier for the active ingredient.  KelSie Biotech has successfully reformulated a wide array of small molecules, antibodies, proteins, nucleic acids, inorganics, antibiotics, and even live, attenuated vaccines into powders suitable for a variety of applications, such as respiratory delivery, stable suspension, and rapid dissolution, with minimal loss of activity.  

  • Processibility: KelSie’s Senior Scientific and Management Staff have spent years developing and perfecting their bubble drying process on a wide variety of applications. Over the past few years they have turned their efforts to developing non-lactose based formulations, with great success.

  • Delivery: Many pure organic substances are crystalline in nature and have an aerodynamic diameter too large to achieve deep lung penetration. Achieving an aerodynamic particle diameter of 1-5 µm, which is necessary for deep lung penetration, is the single most important design variable of a DPI formulation.  Our vast formulation experience, paired with our exclusive technology, affords us the ability to tailor design your dry powder according to your specific application.  KelSie has been testing its formulations with an Andersen cascade impactor, which is recommended by both the U.S. and European Pharmacopeias.

  • Availability to Target Site: By generating specified particle sizes in the formulation/particle formation process, the active ingredients are able to reach the desired delivery location where the dry powder is dissolved and absorbed upon contact with the membrane, increasing the absorption rate and efficacy.  Delivery of APIs in this manner avoids the first-pass metabolism of the liver, and increases the bioavailability of the drug.  The onset of effects of the Active is also accelerated by the delivery directly to the bloodstream.

Each of KelSie’s formulations undergoes rigorous pre-and-post testing via high-performance liquid chromatography (HPLC), gas chromatography (GC), microbial and heavy metal screening as well as respirable fraction determination by Anderson cascade impaction, nuclear magnetic resonance (NMR) spectroscopy and scanning electron microscopy depending on the regulations, intended use and form factor.

 
 

TESTING

 

KelSie is please to extend its testing expertise to ongoing clients as wells as on a project by project basis. The following is a list of commonly performed testing methodologies:

 

  • Quantitative Nuclear Magnetic Resonance Spectroscopy (qNMR)

 

  • High Performance Liquid Chromatography (HPLC)

 

  • Gas Chromatography (GC)

 

  • Inductively-Coupled Plasma Mass Spectrometry (ICP-MS)

 

  • Scanning Electron Microscopy (SEM)

 

  • Coulometric Karl Fischer Titration (KF)

 

  • Andersen Cascade Impaction (ACI)

 

  • Emitted Dose (ED)

 

  • Microbial Testing

 

  • Stability testing

 

LICENSING

 

KelSie maintains its interest in conducting collaborative Research and Development activities with Academic, Research, Government Agencies and  Foundations as well as commercial entities to mutually benefit all parties. To this end, KelSie welcomes opportunities to collaborate with research initiatives related to the formulation, testing and efficacy of products that focus on specific diseases or medical conditions, with the objective of considering entering into a Joint Venture with, or sub-licensing its technology to, selected entities in a defined “Field of Interest” for commercialization.

 

TRIAL DESIGN

 

KelSie has experience in clinical trial design and implementation, with successful projects both domestically and internationally. In addition, KelSie has the equipment necessary to produce highly replicable, robust, pre-clinical and clinical research studies, aimed at the delivery and bioavailability of numerous fine particle formulations. KelSie has the ability to tap into a vast network of academic institutions and professional resources that make the process of trial design and implementation as efficient and cost effective as possible. In addition, KelSie is able to aid in:

 

  • Institutional review board certification process

  • Participant recruitment and selection

  • Demographic analysis

  • In house analytic testing

  • In house delivered dose metric tools and QA

 

ENGINEERING & MANUFACTURING

 

KelSie’s design-engineers have experience in creating custom solutions for a wide variety of applications in the pharmaceutical and nutraceutical spaces. Some of those service include:

 

  • Computer-aided design (CAD)

  • Computational fluid dynamics (CFD) evaluation

  • GMP equipment design

  • HMI implementation

  • Process design & optimization

  • High Performance Cyclone design

  • Solution flow characteristics determination and optimization

  • Powder collection customization

  • Optimization of Thermodynamic properties

  • Delivery device design & testing

 

CONSULTING

 

In addition to the products and services listed above, KelSie offers both remote and on-site consulting services relating to the following areas:

 

Formulation

  • Design & Feasibility

  • Testing

  • SOP auditing

 

CAN-BD

  • Research, Viability/Testing

  • Anderson Cascade Impaction

  • Device compatibility

 

Process & Productivity

  • Efficiency & Organization

  • Quality & Standardization

  • Design & Engineering

© 2020 by KelSie Biotech