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Novasign for Biopharma

# NOVASIGN STUDIO | BIOPHARMA PROCESS DEVELOPMENT

Novasign Studio for biopharma process development

Turn your organization’s process knowledge into reusable workflows. Fewer experiments, faster decisions, and scale-up confidence built on what you already have.
Novasign Studio helps biopharma process development teams structure historical data, existing models, and scientific expertise into reproducible workflows across molecules, platforms, and development stages.

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Start with one product. Build a workflow. Apply it across your portfolio.

Novasign Studio interface showing a design space heatmap for product quality attributes, with a monitor displaying the full temperature and glucose parameter space in yellow-to-orange gradient, and a tablet inset showing the constrained design space with optimal conditions highlighted in red-orange

THE CHALLENGE

The overhead that holds biopharma process teams back

The challenge is rarely a shortage of data, models, or expertise. It is that none of these are structured to be reused across programs, teams, or development stages, and rebuilding what already exists has become part of the job.

Historical knowledge stays locked in the past

Process data exists across campaigns, products, and development stages, but consolidating it into a usable form takes significant effort. When finding and extracting past data feels open-ended, running a new experiment becomes the path of least resistance. Knowledge gets rebuilt not by choice, but because reusing it reliably is harder than it should be.

In-house digital tools rarely scale beyond the person who built them

In-house models, code snippets, and analytical pipelines often work well for the individual who built them. Making that capability available to the broader team, across molecules and sites, is where it consistently stalls.

Process teams need to become advocates for a tool, not just use it

When a workflow does not fit how process teams actually work, even technically strong solutions fail to gain traction. People need to see clear value in their daily work to become defenders of a digital tool.

Scale-up confidence gaps create expensive late-stage risk

Process understanding built at lab scale does not always hold at pilot or manufacturing scale. When that gap surfaces late, the consequences are concrete: delayed programs, failed batches, and unplanned engineering campaigns that could have been avoided earlier in development.

Build-vs-buy inertia slows digital progress

Data processing, model validation and maintenance, a usable interface for process teams, and adoption each become a separate project. In the meantime, teams develop workarounds that get the job done.

HOW NOVASIGN STUDIO HELPS

One connected workflow. From process data to well-justified decisions

Novasign Studio introduces a structured workflow layer across your development process.

Planning → Data processing → Process modeling → Decision support

Novasign Studio gives each step a structured home, open to extension where you need it. It does not replace your existing models, scripts, or data infrastructure, which makes them reusable, reproducible, and shareable across your organization. Each step is designed to fit how process teams already work, not to require a new way of working.

1

Plan

Design smarter experiments around the specific decision you need to make, from screening to model-based Design of Experiments.

2

Process data

Consolidate campaign data from instruments such as bioreactors and PAT sensors, and from data systems such as LIMS and historian, into reproducible, comparable datasets your whole team can work from.

3

Model

Build process models from your data and process knowledge, explainable, auditable, and tailored to the program at hand.

4

Simulate

Run in-silico scenarios to test operating strategies, de-risk scale-up, and evaluate trade-offs before committing to lab or engineering runs.

5

Decide and Reuse

Generate clear, explainable outputs that can be shared across teams, applied to future programs, and built on over time, not rebuilt from scratch.

USE CASES

Where Novasign Studio fits in biopharma process development

One platform for all unit operations. Upstream to downstream, from early-stage feasibility through tech transfer and process handoff.

Historical data proof of concept

The most common starting point is building a process model from data your team already has, such as campaign data from prior development runs, without generating a single new experiment. This lets your team evaluate what Novasign Studio can produce in your specific context, with your own data, before any further commitment. The output is a working model and a clear view of what questions it can and cannot answer at this stage.

Upstream process optimization

Model-based Design of Experiments for batch, fed-batch, and perfusion processes, including seed trains. Rather than screening a predefined set of conditions, Novasign Studio builds a model from your existing data and identifies which untested combinations of process conditions are most likely to contain the optimum. Experimental effort is directed toward the runs most likely to be informative, not distributed across a predefined grid.

Process characterization

Once the process direction is established, the focus shifts to understanding the design space: which Critical Process Parameters (CPPs) drive variability in Critical Quality Attributes (CQAs), and within what ranges does the process remain within specification? Model-based characterization identifies CPP-CQA linkage with significantly fewer runs compared to standard Design of Experiments approaches, with a stronger basis for the characterization package.

Downstream development and robustness

Filtration workflows including Tangential Flow Filtration (TFF) in ultrafiltration/diafiltration (UF/DF) mode and continuous Single-Pass TFF (SPTFF). Chromatography workflows covering batch bind-elute and flow-through formats as well as continuous chromatography. Formulation workflows covering buffer and excipient optimization. Across all unit operations, model-based optimization and characterization establish robust operating windows with fewer runs.

Scale-up and tech transfer prediction

Scenario-based simulation lets the model predict what large-scale performance will look like before engineering or manufacturing runs happen. Those runs are used to validate expectations, not to explore them. Where bioreactor geometry matters, Computational Fluid Dynamics (CFD)-derived parameters such as kLa, mixing time, and power input can be integrated directly into the process model, adding a quantified basis to scale-up predictions. Process understanding is built to be applicable across scales, from lab through pilot to manufacturing.

Cross-project workflow standardization

Process knowledge built for one molecule does not have to stay with that molecule. Novasign Studio captures the experimental planning logic, data processing steps, and model structure behind a process decision in a reusable workflow. When the next program starts, the team begins from an established baseline rather than from scratch, and the knowledge is available to the team, not only to the person who developed it the first time.

22 → 8

Bespark*bio reduced experimental runs from 22 to 8, achieving approximately €40k in material cost savings in a single process development project.

50%+

Bisy GmbH reduced development timelines by more than 50% in an initial proof-of-concept project using Novasign Studio.

5x

Arkeon achieved five times higher titers compared to their standard process.

Who benefits from Studio?

Three types of people tend to find Novasign Studio relevant. If any of these reflects a challenge your team faces, this page is for you.

“My team keeps redoing work we have already done.”
VP of Process Development · Head of Bioprocess Sciences · CMC Director

You have historical data, internal expertise, and development campaigns that produced real process knowledge. The problem is that knowledge is not reusable: it lives in files, tools, and the expertise of individuals who contributed to building it. Without a structured way to capture it, that knowledge stays personal rather than shared, and the next team starts from scratch instead of building on what already exists.

“We have models and scripts that only one person can use.”
Digital CMC Lead · Process Modeling Lead · Data Science Lead

Your team has invested real effort in building digital capability: data processing scripts, analytical pipelines, and models. The people who built them want that work to be useful to the broader team, not locked to their own desk. Novasign gives that capability a structured home so process teams can apply it directly, without needing the original author to explain, translate, or be in the room.

“I need a modeling workflow I can run myself.”
Process Scientist · Research Scientist · Process Engineer USP/DSP

You know the biology and you know what questions need answering. What you need is a workflow you can drive yourself, without waiting for a data scientist to be available or asking them to rerun the analysis every time something changes. Novasign Studio provides an intuitive no-code interface for day-to-day process work, with the models and scripts your colleagues built already integrated and ready to use.

WHY NOVASIGN STUDIO

Why process development teams choose Novasign Studio

One platform. Upstream to downstream. All unit operations – from early-stage feasibility through tech transfer and process handoff.

Reuse what your organization already knows

Historical process data from prior campaigns, development runs, and platform molecules already exists inside your organization. Novasign makes it usable for the next decision instead of designing another experiment to rediscover it.

Bring your own models, scripts, and code

Novasign does not replace internal models or custom scripts that already work for your process. Your existing digital assets integrate directly into Novasign Studio as shared, reusable workflows the broader team can use, not just the person who built them.

Designed for process team adoption

Intuitive no-code interface where process teams need speed. Code-ready where data scientists need flexibility. Transparent model logic every stakeholder can understand. Built so the workflow gains traction across the team, not just deployed.

One platform across all unit operations

Upstream, downstream, filtration, chromatography, formulation, scale-up and tech transfer. One connected workflow rather than multiple disconnected tools. Process understanding from one step informs decisions in the next.

Start with a scoped proof of concept and expand from there

Start with one process question and your existing data. Novasign reviews the scope, delivers a clear proposal, and demonstrates value before any license decision is required. Every successful collaboration we have had with biopharma teams has started this way.

BUILD VS BUY

Build on what you already have

Your organization has valuable code, models, datasets, and scientific expertise. The challenge is not a lack of digital capability, it is making that capability usable, reproducible, and accessible beyond the team or expert who created it. Novasign Studio is designed to accelerate and scale what you are already building.
Internal build or existing tools Novasign Studio
Time to value
Months to years. Data processing, model building, user interface, and adoption are each a separate project.
Weeks to first feasibility result. Workflow infrastructure is pre-built. Data processing included.
Process team adoption
High risk. Tools built by data scientists often require data scientists to run them. Process teams stay dependent on whoever built the tool.
Designed for process teams. Intuitive no-code interface. Transparent models. Built for daily use without specialist support.
Your existing code and models
You own them, but they are accessible only to the expert who built them.
Integrate your scripts and models directly into Novasign Studio in a reusable format. Available to the whole team, not just the person who created them.
Maintenance overhead
Ongoing: Every new dataset, modality, or site becomes a separate IT project.
Maintained by Novasign, with regular software updates and on-premises or cloud deployment options.
Traceable process decisions
Often transparent internally, but difficult to document reproducibly for regulatory dossiers.
Traceable inputs. Documented datasets, workflow logic, and model configuration. Reproducible outputs your team can stand behind.
Entry cost and risk
High total cost of ownership. Talent, maintenance, and adoption often exceed estimates.
Scoped feasibility first. No large upfront commitment. Scale once value is proven.

GETTING STARTED

Start with one process question. See what your data can do.

The right starting point if you want concrete results. We work with you on a scoped proof of concept using your existing process data, so the outcome is relevant to your specific context from the first step.

1

Scoping call
 
Define one process challenge and one unit operation or workflow area to focus on

2

Data review
 
Novasign reviews your existing data and defines what the proof of concept can produce, at no cost to this point

3

Proof of concept
 
We build and run the workflow in Novasign Studio together with you

4

Results and next steps
 
Clear outputs, a defined scope, and your decision on how to proceed
Build digital capability. One workflow at a time.
Book a demo
Get in Touch

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