Preclinical formulation analysis supports toxicity studies before and after the investigational new drug application (IND). Multiple analytical studies support drug development progression beyond the IND stage. KCAS Bio performs analytical studies for a variety of clients.
How Does KCAS Bio Perform Preclinical Formulation Analysis?
KCAS Bio has completed numerous studies with rapid method development and validation, usually in less than 15 days. We perform analyses for a variety of molecules, both large and small, including peptides, proteins, antibodies, and ADCs. The formulation matrix varies from simple to complex formulations with multiple formulation ingredients. We have expertise with many formulation types, such as liquids, capsules, feed, polymers, and spray-dried formulations. The majority of the studies are GLP 21 CFR 58 compliant.
What Does Quality Assurance Look Like for Dose Form Studies at KCAS Bio?
KCAS Bio dose form studies follow all preclinical regulations and include QA oversight in all aspects of instrumentation, lab procedures, and data review. Clients review validation plans and draft reports with regular study updates. Every GLP study has in-phase, analytical data, and report audits.
KCAS Bio begins validating methods using the available test material until the lot materials needed for the studies are ready. The validation process can be comprehensive, evaluating stability throughout the study’s duration at every storage temperature and container type for short or long-term stability studies.
The drug formulation concentrations determine the analytical techniques used in the study, and KCAS Bio ensures the optimal analytical equipment is used. Most study concentrations are between micrograms to milligrams per milliliter, but lower concentrations are common. KCAS Bio has developed methods using UHPLC, UV-Vis, fluorescence, and LC-MS/MS.
Keeping projects on schedule is a priority for KCAS Bio. We qualify test material under GLP conditions to provide a Certificate of Analysis (CoA) and move projects forward.
What Sets KCAS Bio Apart in Drug Dose Form Studies?
KCAS Bio manages projects and study schedule changes. Our company coordinates supply chain and sample receipt, adhering to all protocols, timelines, and regulatory requirements. The fast pace at which we develop and validate analytical methods, combined with the variety of services we offer, sets us apart from other companies. KCAS Bio provides thorough audited reports with a streamlined process to avoid regulatory or project delays.
KCAS Bio dose form methods and expertise
We utilize a wide variety of tools to complete analytical studies. Our primary instrumentation includes UHPLC, UV, and fluorescence, along with UV-Vis, Solo VPE, and LC-MS/MS, depending on the study’s requirements. Additionally, we have expertise with hundreds of different reagents, including polysorbate and methylcellulose, salts, sugars, sterile vehicles, polyvinylpyrrolidone, palmitate, and cyclodextrins.
Our formulation experience ranges from small molecules, peptides, proteins, and oligonucleotides to antibodies and antibody-drug conjugates. Experts at KCAS Bio analyze this entire molecular range and are specialized in handling analytical challenges that different molecule types can bring. Specifically, KCAS Bio provides analytical expertise for fast GLP method development and validation, enabling rapid dose form analysis.
How Does KCAS Bio Stand Out in the Competitive Preclinical Environment?
KCAS Bio is uniquely positioned to handle large and small molecules, thanks to the expertise of our team. Our specialists in chemical and molecular analysis bring a depth of knowledge that sets us apart for our clients.
“We are experts at completing and communicating all scientific and regulatory requirements to develop testing methods, test validation, sample analysis, and analytical data delivery in less than 5 business days of samples arriving at KCAS Bio.“
It’s important to give our clients the confidence that their studies are progressing with accurate data. We pride ourselves on assuring clients that their studies are on track, with validated methods and verified study results. Global pharma clients come to us to solve analytical challenges, such as preparing methods that meet their acceptance criteria. Our scientists address these challenges and communicate to the team how we solve issues while meeting the study schedule.
Who is the Ideal Client for KCAS Bio’s Drug Dose Form Services?
Individuals or companies at the pre-IND stage are ideal customers for KCAS Bio. We are the perfect company to conduct these studies, having successfully addressed these challenges in over 350 studies over the past five years. With a global team of over 100 scientists and project managers with comprehensive expertise, we ensure efficient analytical problem-solving and keep studies on track.
How to become a KCAS Bio client for dose form analysis?
Interested individuals or companies can reach out to KCAS Bio to get a quote, discuss challenges on a call, and meet the team. Typically, the call lasts around 30 minutes, allowing us to review the upcoming program. For a Tox Safety program, there are usually 6 to 10 studies following method validation. Timelines can range from two weeks to as far out as 6 months. KCAS Bio is efficient, fairly priced, and centrally located in the United States and comes highly recommended by both small and large clients we’ve worked with over the past five years.