Pharma · Development

Personalized Solutions for Pharma Development

We help development teams turn promising research into scalable, validated processes through tailored organizational, digital and technical solutions.

5× tägliche Verarbeitungskapazität Automated Compound Hub · Swiss biopharma client

01 · the phase

Development is where promising science meets process reality, and where scale-up surprises, tech-transfer overhead and validation rework eat timelines. We know these bottlenecks and prove which one is worth moving with a 4-week PoC, before it threatens a Phase-III milestone.

02 · what we hear

Key challenges, and how AI-driven transformation helps.

  • Scale-up-Risiko
    Challenge

    Der Prozess läuft im Labormassstab, und niemand ist sicher, dass er im Pilotmassstab hält. Der Transfer an den nächsten Standort heisst, Batch Records von Hand aus Dokumenten neu aufzubauen, die für eine andere Anlage geschrieben wurden, und die Annahmen, die den Umzug nicht überstehen, zeigen sich erst in der Kampagne danach.

    How we help

    Wir identifizieren die Risikobereiche entlang des Technologietransfers, die sonst erst in Phase III auftauchen, und liefern einen validierungsreifen Pfad für erfolgreiches Skalieren.

  • Daten über Targets hinweg abbilden
    Challenge

    Sequenz- und Strukturdaten verteilen sich über Projektberichte und Geräte-Exporte, also heisst die Prüfung, ob ein verwandtes Target bereits charakterisiert wurde, Datei für Datei zu öffnen statt eine Abfrage zu starten.

    How we help

    Wir entwickeln Knowledge Graphs, die die verschiedenen Datenschichten zusammenführen und analysieren, und helfen zu erkennen, welche Sequenzen und Strukturen mit neuen krankheitsrelevanten Targets zusammenhängen.

03 · use cases

What a 4-week PoC could target.

Automated compound handling

A platform for powder weighing and liquid handling, built for throughput.

We own the system specifications and the functional-design phase, architect the high-throughput solution, and reconcile business and technical requirements with stakeholders, designed for global rollout with safety and priority handling built in.

What good looks like

  • Higher daily processing capacity
  • Standardized order processing across the department globally
  • Safer handling, reduced operator exposure

Process data model & ontology

A shared data model that survives tech transfer between sites.

We define a focused data model and an agreed ontology, an end-to-end view of what data exists and how it should be structured to be FAIR, consistent and reusable across development and tech transfer.

What good looks like

  • Aligned definitions across sites
  • Reduced redundancy and rework
  • A future-proof, AI-ready data blueprint

Throughput & variability automation

Automate repetitive steps to lift capacity and cut variability.

We identify the highest-leverage manual steps and automate them, standardizing process execution so throughput rises and batch-to-batch variability falls.

What good looks like

  • More daily capacity from the same team
  • Standardized, repeatable execution
  • Lower variability batch to batch

Equipment make-or-buy evaluation

Decide which development tooling to buy, build or skip.

Vendor-agnostic assessment and selection based on pre-defined criteria, with a costed recommendation and an integration path for the right partners.

What good looks like

  • A defensible buy / build / skip decision
  • Costed options and an integration plan
  • Right-sized partner selection

Scale-up data pipeline

Surface scale-up surprises early, not in Phase III.

We instrument pilot-batch and process data so deviations and scale-up risks become visible early, with a clear data flow from bench to pilot.

What good looks like

  • Earlier detection of scale-up risk
  • A connected bench-to-pilot data view
  • Fewer late, costly surprises

04 · proof

Work, re-framed for this phase.

Automated Compound Hub · Swiss biopharma client

Process standardization and throughput at scale, a fully automated compound hub that took daily capacity 5×. The same discipline that de-risks a scale-up.

Background
Growing global volume of compound orders for powder-solution production with varying priorities. The compound-management team was strained on productivity, sample tracking and prioritisation.
Solution
Personalized Solutions workshop to optimise workflows, then a fully automated platform for powder weighing and liquid handling, designed for global rollout, with throughput, safety and priority handling built in.
Results · 12 mo. after engagement
Daily processing capacity up by more than 500%. Lab processes automated and optimised. Global standardisation of order processing across the department.
inite's role
inite provided a Scientific Business Analyst and Solution Architect. Owned system specifications and the functional-design phase. Architected the high-throughput solution. Negotiated with stakeholders to reconcile business and technical requirements.

“Inite contributed significantly to the success of our projects with excellent and well-founded analyses. Their structure and committed way of working was greatly appreciated by the team.”

Compound Management Director · Global Pharma Company

Digital Biorepository · Swiss pharma client

A standardized, FAIR-ready data model across sites, the structural backbone validated development depends on.

Background
Cross-site collaboration on bio-sample management, biosamples (cells, proteins, plasmids, antibodies) distributed across multiple locations with no clear structure. Tracing, accessing and collecting the right samples was slow; scientific productivity was capped.
Solution
A global virtual + physical solution to handle, search and retrieve biosamples. Secure cross-site sharing, AI-contextualised digital + physical storage, and an integrated request → register → store workflow.
Results · 12 mo. after engagement
Remote and centralised access to bio samples. Faster data access. Lower experiment time and cost. ~35% efficiency improvement.
inite's role
inite concepted, designed and managed the full DBR implementation across life-science, IT and business domains. Delivered a standardised Bio-Sample Data Model aligned with FAIR principles. Aligned multiple sites and functions on a single workflow.

“Inite positively influenced a change of mindset and supported us to approach the task with fresh thinking. Their approach allowed the team to imagine solutions in an unlimited way rather than being held back by constraints and obstacles.”

Global Process Owner, Biosample Management · Global Pharma Company

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