The Klyo Advantage
Klyo is a Greek work that means “to hear, to listen.” If you are producing biopharmaceutical material, of any quantity and anywhere along the drug development lifecycle, let’s talk.
If you do, 300+ cumulative years of biopharmaceutical experience will sitdown with you and your team, to hear your latest challenges and to help you solve problems. That’s the Klyo advantage.
We truly do listen. We know that it is the only way we can understand where we might fit in.
Scientists are not always engineers. While scientists provide the sweat, time and inspiration behind every new therapeutic, the team that finds a way to deliver cGMP compliant kilograms of material necessary for clinical trial, or builds the commercial facility to do so, will ultimately have a huge part in determining the commercial viability of a new drug.
If you need to understand the economics of scale-up after a successful Phase I, we can help. If you are working on biosimilars, we hear you. Having trouble manufacturing enough Lenti or AAV Vector material? Let’s hear it. We can provide you with a package that maps the journey from Phase II to Phase III. Need to get to market faster? We have ideas. Thinking acquisition? We can help you value the possibilities.
Our greatest challenge is actually developing a hardcopy list of the services we offer, because KLYO is about having no boundaries on what we can discuss. If you are producing biopharmaceutical material, of any quantity and anywhere along the drug development lifecycle, call us for a chat. The insight gained will be worth the time. (see What Clients Say About Us).
This is group of individuals who want to work on projects in our industry that will make a difference. To you, to the industry and to the patients whose lives we can improve.
Product/Process Development and Manufacturing expertise:
• Biologics, Biosimilars, MAb’s, Vaccines, rProteins
• Drugs: Oral Solid Dosage
• Cell, Gene and DNA/RNA therapies
• Medical Devices / Disposables
Lifecycle Continuum Strategies to reduce Time-to-Market
Strategic planning for Value Creation
Quality, Regulatory, Scientific, and Clinical development services for the US and global markets
Predictive Tools for Process Automation of Facility Estimating
Facility Design including Multi-variable Modeling
Scale-up at each stage of Biopharmaceutical Development
Optimization of Automation and Information Management Systems
Supply Chain, Inventory Control, and Logistics Strategies
Experience gained from numerous, successful INDs and product licensures in the US, EU, Japan and Australia: Four Continents (and counting)
Record of Success – INDs, NDAs, BLAs, 510(k)s and IDEs
cGMP Facility Design / Build with full Compliance and Commissioning
We use predictive and proactive tools to enable visualization of everything we discuss.