Pharmaceutical formulation is quietly changing. For the last 50 years, drug formulation relied on long iteration cycles, and trial-and-error: mixing excipients -> testing -> seeing what happens -> improve and repeat. For new highly complex molecules, this approach is no longer viable. This is why the industry is shifting to a predict-first, science-driven strategy. Quality-by-Design is now endorsed by regulators and outlined in the ICH Q8(R2) guidance.
At amofor we provide the enabling technique: a computational platform based on first-principle science. Our models, derived directly from the fundamental laws of thermodynamics, provide clear, mechanistic insights into how your molecules behave under real-world conditions. We translate these advances into practical tools for your formulation development.
This guide provides a comprehensive overview of our core services. It covers everything from drug-polymer compatibility and release dynamics to spray drying design and shelf life prediction. Discover how we operationalize this to help drug formulators move smarter and faster, with confidence at every stage of the process!
1. Our Core Service Packages: Digital-by-Design
We offer three core service packages designed to support formulation teams from early-stage discovery to late-stage clinical formulation questions, each delivered with decision-ready outputs.
1.1 What Is the Right Polymer for My ASD?
The goal of this service is to provide formulators with a polymer that ensures both ASD stability and effective drug release. Choosing the right polymer is the first major decision in ASD development, and one of the most consequential. The optimal stabilizing polymer for an API differs from API to API. A polymer might stabilize the solid form but lead to poor drug release, or it might seem viable until you exceed a certain drug load and the system breaks down.
At amofor, we start by modeling the fundamental intermolecular interactions between your drug and a wide range of polymers (e.g., HPMCAS grades, HPMC, PVPVA, PVP, Soluplus, Eudragit, PEG, PVA). Data from few key experiments characterize the true net intermolecular interactions, which we use to parameterize our models. With PC‑SAFT, we compute molecular interaction strengths, assess miscibility, and estimate the maximum drug load for the ASD. We also predict whether the release will be congruent or not, an early indicator of precipitation or supersaturation failure.
This combined viewpoint gives you a picture of your formulation’s physicochemical performance, focusing on the in-vitro properties critical to achieving in-vivo efficacy.
Deliverables:
- Compatibility ranking: Polymers ranked by interaction strength with your API.
- Miscibility + drug load maps: Visual indicators of phase separation and miscibility windows.
- Release type prediction: Basic congruent vs. incongruent release forecast.
- Stability insights: Estimated glass transition temperatures and solid-state stability indicators.
The dataset also gives you a deep scientific rationale, defendable in regulatory submissions. The model is expandable: you can add further simulations like advanced release modeling or solubility enhancements.
Data Required: 5 solubility points for the API (no structure needed)+ one DSC
Turnaround: 2 – 3 weeks for the entire package.
Related Reading & Examples in Practice:
Polymer Screening Case Study | Drug Release Prediction | AbbVie–Purdue Case Study
1.2 Spray Dryer Design for Robust Manufacturing of ASDs
This service is designed to de-risk your journey from solvent selection to dry powder by providing a robust and scalable spray drying process blueprint. Spray drying is a core technology for producing ASDs, but it often remains a black box. Will your solvent system cause phase separation? How will your particle behave during scale-up? Unexpected issues like low yield or solvent residue can compromise timelines and budgets.
amofor brings clarity to this complexity. We use thermodynamics and kinetic modeling to simulate the entire process in silico, from the stability of your feed solution to the efficiency of your secondary drying. Our models predict the physical behavior of your formulation throughout the drying trajectory, transforming intuition into mechanistic understanding. They replace costly design-of-expermients, that can explore only a tiny slice of the spray drying universe, with predictive simulation.
Deliverables:
- De-risked solvent system:Data-driven recommendations on solvent/co-solvent mixtures to prevent solvent-induced demixing and ensure complete dissolution before spraying.
- Evaporation trajectory map:A visualization of the droplet drying path that flags critical risks like solvent accumulation due to uneven volatilities, helping you avoid poor particle morphology.
- Virtual DoE for scale-up:A simulation of multiple spray drying conditions (e.g., inlet temperature, feed rate) to identify the optimal operating window and compare process alternatives (e.g., closed-loop vs. open-loop), de-risking scale-up before a single experiment.
- Residual solvent & stability forecast:Predictions of residual solvent content in your final particles and a tailored secondary drying strategy to ensure ICH compliance and reduce drying times.
This service provides a comprehensive guide for your spray drying process ensuring your process is efficient and scalable.
Data Required: Solubility data for API and excipients in relevant solvents, and basic spray drying parameters.
Turnaround: 4 – 8 weeks for the comprehensive package.
Related Reading & Examples in Practice:
Spray Dryer Design Blog | Secondary Drying Time Optimization
1.3 How Long Will My Amorphous Formulation Remain Stable?
The goal of this service is to accurately predict the shelf life of your ASD and identify crystallization risks under real-world storage conditions.
Is your API one with a moderately low glass transition temperature that can crystallize quite quickly? This combination is a sign of physical instability. Traditional shelf-life predictions fail here because they rely on chemical degradation models that are ineffective for physical crystallization.
At amofor, our model leverages PC-SAFT thermodynamics, molecular mobility, and nucleation kinetics, integrating critical factors like drug load, glass transition, and humidity. This physics-based approach is rigorously validated across more than 150 stability datasets, predicting real-world crystallization with ±20% accuracy.
Deliverables:
- Validated crystallization forecast: A precise, shelf-life prediction quantified and validated against real-world studies.
- Stability risk maps: Easy-to-interpret diagrams that visualize how temperature and humidity interact to accelerate or delay crystallization, defining your product’s safe storage “zone.”
- Stability phase diagrams: Advanced diagrams that map the stability regions of your ASD, identifying conditions where it will remain stable or undergo crystallization.
- Drug load & Polymer impact analysis: Clear data on how different formulations directly impact long-term stability, allowing you to select the most robust option.
This service provides a data-driven shelf-life estimate and a deep rationale that supports your regulatory strategy and de-risks your commercial product.
Data Required: Solubilities in five organic solvents, 1 DSC measurement, and basic crystallization data for the API.
Turnaround: 4 – 6 weeks
Related Reading & Examples in Practice:
Janssen Case Study: Redefining ASD Shelf Life Predictions | Shelf life predictions of ASDs
2. Advanced Thermodynamic Modeling Services
Is your challenge more complex than a standard usecase? We apply our core thermodynamic expertise to tackle your most unique problems, whether in novel pharmaceuticals or other industries.
Our Custom Modeling Capabilities:
- Complex formulation systems: Predictive modeling for lipid-based formulations (e.g., SEDDS/SMEDDS) or lyophilization cycle optimization.
- Specialized drug delivery: Design and analysis of mucoadhesive films, sublingual formulations, and other non-standard delivery platforms.
- Cross-industry applications: Applying our physical modeling expertise to challenges in the food, chemical, and consumer goods industries.
This service offers a tailor-made computational solution to your specific R&D challenge. You get a model and a scientific basis for your design decisions.
Turnaround: Project-dependent, defined in a tailored statement of work.
Related Reading & Examples in Practice:
Blog: Beyond ASDs – Modeling Complex Formulations
3. What Makes amofor Different
Six years ago, amofor was founded on a simple principle: empowering smarter drug formulation with faster answers and a deeper understanding. Today, that principle drives our partnerships with leading pharma teams across Europe and North America.
We are not a CRO, nor a software vendor. We are a scientific partner, blending cutting-edge modeling with practical applications and formulation expertise. Our approach is defined by three core principles that transform how we solve complex formulation challenges.
- Science at the frontier
Our foundation is first-principles science, models derived from thermodynamics and chemistry that explain the why behind your formulation’s behavior. We continuously integrate the latest research into our SOLCALC platform, ensuring you benefit from state-of-the-art physics-based modeling that is both profoundly insightful and rigorously practical. - Deep domain expertise
We pair our powerful software with deep expertise in pharmaceutical formulation. This combination ensures you receive not just data, but interpreted insights and strategic guidance. We help you understand the connections between molecular properties, process parameters, and final product performance. - Tailored collaboration
We reject the one-size-fits-all approach. Thanks to our flexibility and commitment to exclusivity, most of our work is custom-made. We begin with your specific problem and adapt our models to your unique molecule and goals. This ensures the answers we deliver are precisely the ones you need to de-risk development and accelerate your timeline.
How to Work With Us
We believe in a simple, fast, and personal start. Your project begins with a discovery call with our CEO, Christian Lübbert, to discuss your molecule, goals, and key challenges. Based on this conversation, we provide a clear scope, quote, and timeline.
Once you decide to proceed, we kick off the project. For most core services, you can expect initial insight report within a few weeks. For teams building long-term capability, we offer full licensing and training for our SOLCALC software, empowering your formulators to run simulations in-house.
For the best results, we recommend engaging with us early in your development process. This allows us the time to provide the deepest insights and build a collaborative partnership that systematically de-risks your path to a successful formulation.