Our integrated first-in-human services specifically designed 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.

We have designed an integrated package to address these challenges and simplify the pathway to FIH.

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 dissolution 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

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

 

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 needs of the vast majority of phase I programs, and provide integrated drug substance and drug product in 32 weeks, incorporating:

  • 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

Regulatory services can include:

  • Developing briefing books and support for Regulatory Authority meetings
  • Writing CMC / Quality sections for global CTA
  • Provide final IMPD / IND CMC sections
  • Commercial eCTD for MAA/NDA/BLA/ANDA

Clinical supply services can also be provided, covering management of clinical supplies, kitting, primary and secondary packaging, global distribution and cold chain logistics, and RAD (returns, accountability, and destruction).

And our track record gives you the security you seek – our site network has been routinely inspected by global regulatory agencies inclusive of the US FDA, MHRA, ANSM, PMDA, Swissmedic, and SFDA.


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