SimpliFiH™ Solutions for Phase I Clinical Studies

Take your BA-challenged molecule to Phase I in 32 weeks or less

Start with a partner that can accelerate your bioavailabilty-challenged molecule to phase I, and on to commercialization

Lonza’s integrated first-in-human services for bioavailability-challenged molecules.

With the pharmaceutical industry’s focus on accelerating all aspects of drug discovery and development, it is increasingly critical to reduce the timeline from initial idea to first-in-human (FIH) clinical verification.  Aligning with a single, integrated and proven service partner can reduce timelines, as well as reduce the complexity, risks and costs associated with engaging multiple partners.

Bioavailability challenges, which are often a challenge in advancing new molecules and require enabling technologies even for phase I studies, must be factored into the choice of development partners. 

Another factor is phase-appropriate processing for API, particle engineering and specialized finished drug products which can further accelerate the pathway to and through phase I.

SimpliFiH Solutions is  specifically designed to reduce phase I timelines by at least 3 months vs traditional approaches.  This service is also designed for the flexibility required to fit your molecule and drug program:

  • API to OEB 4 – dedicated kilo-labs and teams in place to provide the quantities necessary for preclinical and early clinical trials
  • Solid state characterization – API physicochemical characterization, aqueous solubility, salt and polymorph screening services
  • Solubility and solubility rate enhancement – proprietary modeling / technology selection services and manufacture of enabled phase I drug product with required dissolution rate and/or aqueous solubility
  • Drug product in phase-appropriate format: powder-in-capsule, powder-in-bottle, liquid-filled hard capsules or tablets

SimpliFiH Solutions centers on a rapid technology selection methodology that requires a single gram of API to identify a phase I appropriate approach to address poor bioavailability and solubility: particle size reduction, spray dried dispersion (SDD) technology or liquid/lipid based technology.  Eliminating parallel technology evaluations saves precious API and time in reaching phase I clinical trials.

Powder-in-capsule / powder-in-bottle formulations utilize our proprietary Xcelodose® Precision Powder Micro-dosing Technology for early phase drug product evaluations.  These systems can accurately dose to as low as 100 mcg, and accelerate phase I pathways by up to 17 weeks by avoiding time-consuming excipient compatibility studies. 

One partner for integrated API and drug product development to reduce program timelines, complexity and risk.  Start with a proven and flexible service provider that can simplify your journey to phase I and onwards - Lonza.

“What makes them better? … technical competence, straight-forward communication, a collaborative approach and their ability to provide the flexibility we need”
A Lonza client for small molecule product development services
By using a single service provider, an estimated 19 weeks can be saved through phase I..
“Assessing the Economics of Single-Source vs. Multi-Vendor Manufacturing” Oct. 2017, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston MA.

We have leveraged our extensive technologies and early phase capabilities, and the experience of developing and advancing thousands of molecules, to develop a service package that fit the needs of phase I studies. 

Our basic SimpliFiH Solutions package is designed to meet the vast majority of phase Iprograms that we have conducted over 25 plus years’ experience, and provide integrated drug substance and drug product in 32 weeks for as little as $400K.  The basic SimpliFiH Solutions package includes:

  • Single project manager for ease of communication
  • Simple and phase-appropriate service agreements, terms & conditions 
  • Fit-for-purpose process development 
  • Phase I qualified drug product methods
  • GMP documentation, including batch records and CoA
  • Suitable drug product stability package 
  • Options for program customization

Service Component

Timing

API Only

16 weeks

API + PIC / PIB

32 weeks

API + micronization* + PIC / PIB

32 weeks

API + LFHC*

32 weeks

API + SDD*

32 weeks

* Technology Selection included in the timing and pricing

 
The basic package can be customized to include full product development, full analytical method development and validation, CMC documentation and regulatory services to support your IND / IMPD submission requirements.  
 
And our track record gives you the security you seek – our site network have been routinely inspected by global regulatory agencies inclusive of the US FDA, MHRA, ANSM, PMDA, Swissmedic, and SFDA.

For further information contact us a SimpliFiH@lonza.com.