IN SILICO FORMULATIONS

Faster designs. Reduced clinical risk.

In-Silico Evaluation

Qrono can use our predictive modeling software to determine the range of release durations that are feasible for a given API.

We can also evaluate:

  • The ability to meet clinical performance targets with human pharmacokinetic (PK) simulations,
  • The complexity of production scale up based on in vitro – in vivo correlation (IVIVC) simulations, and
  • The performance of a clinically optimal formulation in relevant animal models with preclinical PK simulations.

Download a sample In Silico Evaluation Report:

Sample 28-day In Silico Evaluation Report:

Qrono delivers comprehensive reports analyzing a long-acting formulation’s release performance.

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Proof-of-Concept Formulation Design

Qrono offers contract design services to develop controlled-release formulations significantly faster than current practice. Formulation design is our core area of expertise. Qrono’s design service reduces the development time and risk of failure associated with long-acting controlled-release formulations by enabling the predictive design of these formulations. Optimal controlled-release formulations can be designed in weeks instead of months or years.

Formulation Case Study

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We make custom, long-acting, controlled release formulations of poly(lactic-co-glycolic) acid (PLGA) and other biocompatible materials with extensive track records of FDA approval that deliver drugs or biologics over days, weeks, or months.  These formulations include injectable microparticles, matrix implants and thin-film coatings.

Qrono can predictively design an in vitro release profile for one or more active agents, including:

Small molecule drugs  |  Peptides  |  Protein & Enzyme
therapeutics  |  Antibodies  |  Viral vaccines

We use our proprietary software, called QronoMetrics, to create custom controlled release formulations meeting the customer’s specifications for active agent, dosing, administration route, and excipients. This software also contains Quality by Design (QbD) routines that automatically de-risk our formulation designs for performance errors likely to arise from production.  Our automated approach brings unparalleled speed to design and sets our custom controlled release formulations apart in their safety, consistent quality, and precise performance.

QronoMetrics™ Inputs and Process

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Candidate Selection Program

Controlled release formulations can enable new modes of treatment such as immune-targeting, nose-to-brain aerosols, and other local delivery scenarios that lack well-defined bounds for efficacy.  Qrono can facilitate the study of novel treatment scenarios with rapid design and production of prototype formulations.

Lead candidates may be more or less amenable to a long-acting formulation.  Qrono’s in silico analysis can help to down select which lead candidates should advance.

Qrono’s long-acting formulations are custom engineered to deliver active agents efficiently within the customer’s preclinical study timelines.  To enable detailed research, Qrono can also engineer these formulations to include agents for fluorescence microscopy, live animal optical or magnetic resonance imaging and environmental probes that report local changes in free-ions, pH or other conditions.

Qrono’s long-acting formulations are also ideal for scientific research and early-stage biotech drug development. By adding long-acting viability and controlled-release kinetics to the product package, promising compounds can be more appealing for pharmaceutical licensing.

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