☰

CordenPharma International GmbH

Scaling peptide capacity without splitting the network

Industry
Pharmaceutical Contract Development and Manufacturing (CDMO)
Headquarters
Frankfurt am Main, Germany
Public information as of
January 2026

A4BEE prepared this analysis from publicly available sources. It reflects our own reading of CordenPharma International GmbH's published strategy and is not endorsed by, or produced in cooperation with, CordenPharma International GmbH. Company website

Strategic priorities

CordenPharma is committing more than EUR 1 billion to peptide manufacturing capacity to reach a targeted EUR 1.8 billion of group revenue by 2028. The programme includes a greenfield facility at Getec Park in Muttenz, Switzerland with a disclosed budget above EUR 500 million, a roughly 50 percent expansion of Solid-Phase Peptide Synthesis (SPPS) capacity at Boulder, Colorado to more than 42,000 litres, and further investment in the Frankfurt, Liestal and Plankstadt sites.

The group operates 11 cGMP facilities in Europe and North America across five technology platforms: Peptides, Lipids and Carbohydrates, Injectables, Highly Potent and Oncology, and Small Molecules. The Muttenz site is being designed around advanced automation and digital specification to meet Biologics License Application (BLA) standards; the older sites in Bergamo, Liestal and Chenôve run equipment and software that pre-dates the current generation of plant systems.

Capacity is being scaled against a backdrop of GLP-1 demand that the industry estimates pulls 45 times more solvent through a peptide process than through a small-molecule one. CordenPharma Colorado's 2024 environmental report shows total bulk liquid waste sent offsite rising 54 percent year on year, with water and acetonitrile separation named as the key technical constraint. The same report records the site's commitment to the Science Based Targets initiative (SBTi) and to the Pharmaceutical Supply Chain Initiative (PSCI) Supplier Partner status adopted in March 2025.

The C-suite has signalled what it expects from the investment in technology: the CEO has spoken about shifting from firefighting to foresight and has pointed to artificial intelligence as a near-term tool for batch record and SOP work, while the Chief Quality Officer has described the need for a single-access portal covering quality, environmental and operational data. The digital work that follows has to span both the new Muttenz specification and the established Bergamo and Liestal operations if those signals are to be acted on consistently.

Challenges we see

  • Data Digital Transformation

    Aligning quality and process data across 11 cGMP sites

    The group is moving from a federation of separately run manufacturing sites to a globally integrated network. Quality control, process monitoring and supply chain systems currently sit inside individual sites rather than reporting through a common layer.

    Where the same quality indicator is recorded in different shapes at different sites, leadership reads each site against its own definition; a shared model lets a deviation seen in Boulder be checked against the same reference at Frankfurt and Liestal.

  • IT/OT Industrial Automation

    Specifying Muttenz while operating legacy sites

    The Muttenz greenfield is being designed around advanced automation and digital specification, while Bergamo, Liestal and Chenôve run equipment and software ecosystems that pre-date the current generation of plant systems.

    Equipment selection and integration choices made now decide whether the new site can share data with the rest of the network, so the procurement language becomes a long-term interoperability choice as much as a purchase decision.

  • Quality Data Integrity

    Reducing the share of manual work in batch records and quality control

    Boulder recorded a 15 percent production increase in 2024. Quality records in the older facilities still rely on paper or spreadsheet flows, and the industry context shows rising Warning Letter activity around laboratory controls and discrepancy investigation.

    At higher batch volumes the cycle time of a paper-driven review sits closer to the cycle time of the next batch, which moves electronic batch records and instrument integration from a quality improvement project onto the release path.

  • Sustainability Environmental

    Keeping SBTi and PSCI commitments credible as production scales

    GLP-1 peptides require roughly 45 times more solvent than a small molecule. CordenPharma Colorado reported a 54 percent year-on-year increase in bulk liquid waste sent offsite in 2024, with water and acetonitrile separation identified as the key recovery constraint.

    As production rises, environmental performance moves from an annual reported figure to a per-batch number that has to be captured during the run if SBTi and PSCI reporting are to be defended in the same year the production happens.

  • Integration Digital Architecture

    Joining the new peptide lines to existing operations

    Boulder is adding large-scale peptide lines alongside reactors that have been in service for years. The Muttenz site is being built greenfield and will have to share data with Frankfurt, Liestal and Plankstadt from day one of operations.

    Without a common data and integration model, the new lines run as parallel sites instead of as nodes in one network, and the operations cockpit the leadership has described becomes a federation of dashboards rather than one view.

Opportunities, by urgency and business impact

Each bubble is one opportunity, numbered to match the list below. Further right means it bites sooner; higher means a bigger effect on the business. A bigger bubble means a bigger implementation effort.

Source: A4BEE analysis of public sources

  1. A common data model across the 11 cGMP sites

    Quality, process and environmental data are recorded in different systems at different sites, and the same indicator can carry different definitions depending on where it was captured.

    An ontology that names assay, batch, lot, instrument, environment and deviation once lets every site load against the same model, so leadership reads one consistent picture and sites compare against the same reference.

    • CordenPharma press release, EUR 500 million Muttenz greenfield, 2025
    • CordenPharma facilities network overview

  2. An open integration model written into Muttenz procurement

    The Muttenz facility is in design, and equipment selection happens before construction. Older sites have been built around proprietary vendor ecosystems and high-cost bespoke integration each time a new instrument is added.

    Writing OPC UA (Open Platform Communications Unified Architecture) information models and Module Type Package (MTP) compatibility into the procurement requirements makes interoperability a purchase condition rather than an integration project after handover.

    • CordenPharma, EUR 500 million Muttenz greenfield announcement, 2025
    • CordenPharma, Capacity and modality investment summary, 2025

  3. Electronic batch records and instrument-connected QC

    Paper and spreadsheet flows in older facilities put manual review on the release path. The 15 percent Boulder production increase in 2024 raises the number of batches that each cycle of manual review has to carry.

    Capturing QC results at the instrument and writing them into an electronic batch record shortens the release path and makes the evidence chain readable end to end during an inspection.

    • CordenPharma Colorado FDA and ANVISA inspection close-out
    • CordenPharma, capacity and modality investment summary, 2025

  4. Per-batch solvent and energy data for SBTi and PSCI

    CordenPharma Colorado reported a 54 percent year-on-year increase in bulk liquid waste sent offsite in 2024. Water and acetonitrile separation limits solvent recovery, and SBTi-aligned reporting currently relies on annual aggregation.

    Capturing solvent, energy and waste at batch granularity and modelling recovery options before physical changes are made lets the site act on environmental performance during the year rather than after it.

    • CordenPharma Colorado Environmental Programs Status Report, 2024
    • CordenPharma, Science Based Targets announcement

  5. One integration layer for greenfield and brownfield sites

    Muttenz and the expanded Boulder lines will be commissioned while Bergamo, Liestal and Chenôve continue running equipment from earlier automation generations. Each new connection to the central SAP or LIMS (Laboratory Information Management System) currently needs bespoke work.

    A reference integration architecture, with edge protocol translation for older controllers, makes each new connection a configuration step instead of a project, and keeps the security model consistent across both greenfield and brownfield.

    • CordenPharma facilities network overview
    • CordenPharma, Muttenz greenfield press release, 2025

What we'd propose

  • Enterprise AI

    Industrial data platform for the global CDMO network

    An ontology-based data platform that defines assay, batch, lot, instrument, environment and deviation once, then loads every site's quality, process and environmental data against that shared model.

    • Shared CDMO ontology

      One agreed set of terms

      Define the entities every site already records — assay, batch, lot, instrument, environment, deviation — as explicit entities with agreed relationships, so the same indicator reads the same way whether it was captured in Frankfurt, Boulder or Muttenz.

    • Pipelines from site systems

      Loading every site

      Build ingestion for site QC, LIMS, manufacturing execution and environmental data with schema validation at the boundary so a record that does not match the model is flagged at the source instead of corrupting the global view.

    • Operations and sustainability dashboards

      One view across sites

      Expose the model through dashboards that combine quality, process and environmental indicators, with drill-down to the source record so a number on a chart can be traced back to the instrument that produced it.

    • Leadership reads one consistent picture across the 11 cGMP sites.
    • Environmental, quality and process indicators share the same definitions, which simplifies SBTi and PSCI reporting.
    • New sites, including Muttenz, attach to the existing model rather than triggering another migration.

    We've done this before

    See how we do Enterprise AI
  • Digital CDMO

    MTP-based integration architecture for the Muttenz greenfield

    An MTP-compliant automation architecture specified at procurement, so the new peptide lines connect to the rest of the network through documented interfaces rather than through vendor-specific projects.

    • Open integration backbone

      OPC UA and MTP at the core

      Specify OPC UA (Open Platform Communications Unified Architecture) information models and Module Type Package (MTP) compatibility as purchase conditions, so each SPPS reactor and purification module publishes its data and accepts commands in a documented, vendor-neutral form.

    • Plug-and-produce module onboarding

      Weeks instead of months

      Design module handshakes so a new Solid-Phase Peptide Synthesis reactor or chromatography skid can be brought into the control application through configuration rather than through a new integration project.

    • Reusable procurement and acceptance language

      One specification across vendors

      Write the integration and acceptance tests once, so each equipment vendor bids against the same target and the validation evidence reads consistently across the facility.

    • Interoperability is bought with the equipment rather than built after commissioning.
    • Future peptide structures and new modules can be added without re-architecting the line.
    • The same specification is reusable as other CordenPharma sites are modernised.

    We've done this before

    See how we do Digital CDMO
  • Digital Lab

    Electronic batch records and instrument-connected QC

    Integration between QC instruments, the LIMS or ELN (Electronic Lab Notebook) and the manufacturing batch record so results reach the release record as data carrying their own audit trail.

    • Instrument integration

      Results captured at source

      Connect HPLC (High-Performance Liquid Chromatography), balances, plate readers and peptide-specific analysers so results are captured with instrument identity, method version and timestamp attached, rather than being read off a screen and typed into another system.

    • Lab to batch record data flow

      QC result to batch record

      Map lab sample and result records onto the manufacturing batch record so the release decision can be traced back to the specific analytical run that produced each number.

    • GxP (Good Practice) compliant electronic records

      Evidence that holds up

      Implement electronic signature, versioning and audit-trail handling to GxP expectations, including 21 CFR Part 11 (the US rule on electronic records and signatures) and EU Annex 11, so the evidence chain stands on its own during an FDA, EMA or ANVISA inspection.

    • Manual transfers between lab and batch record fall, taking time and review load with them.
    • Inspection questions are answered from the record itself rather than from a reconstruction.
    • Release waits on the analytical result, not on the paperwork that follows it.

    We've done this before

    See how we do Digital Lab
  • Agents

    AI agents for regulatory, tech-transfer and quality documentation

    Narrow, reviewable agents that take the document-assembly load that comes with a EUR 1 billion capacity programme: drafting batch record summaries from source data, producing tech-transfer documents from a defined template, and finding every controlled document a standards change touches. A named person approves every output.

    • Drafting from source records

      First drafts from system data

      Generate the first draft of a deviation summary, a tech-transfer document or a periodic review from the underlying system records, so the author edits and judges rather than assembles.

    • Template and completeness checking

      Gaps found before review

      Check a submitted document against its regulatory template and the site's own checklist, returning missing or inconsistent sections before it enters the human review queue.

    • Change impact search across the document set

      Which documents a change touches

      When a method, standard or specification changes, retrieve every controlled document that references it and rank them by how directly they are affected, so the update scope is known on day one.

    • Review queues move faster because documents arrive complete.
    • The scope of a standards change is established by search rather than by recollection.
    • Every output is traceable to the source records it came from and signed off by a named reviewer.

    We've done this before

    See how we do Agents

Digital maturity: today and target

Scored out of 100 across six dimensions. The target is what CordenPharma International GmbH's own published ambition implies — not a perfect score.

Source: A4BEE analysis of public sources
Multi-site data integration 30 → 85
Eleven cGMP sites run separate QC, LIMS and manufacturing execution systems. The data platform work is ahead of the network rather than behind it, so the gap is the unifying layer itself rather than the underlying instruments.
Manufacturing automation 45 → 90
Muttenz is being specified for advanced automation, while Bergamo, Liestal and Chenôve carry pre-digital era equipment. The group sits between a greenfield specification and the installed base that surrounds it.
Data integrity and compliance 40 → 90
Colorado completed FDA and ANVISA inspections with no observations, and the group's compliance posture is a clear asset. Older facilities still rely on paper or spreadsheet flows, which is where the next gains sit.
IT/OT convergence 25 → 80
Plant controllers do not currently feed the business analytics layer in real time, and bespoke integration is the rule each time a new instrument is added. The Muttenz design phase is the moment to set the reference architecture.
Sustainability analytics 35 → 80
SBTi and PSCI commitments are in place, and the Colorado environmental report is published. Per-batch solvent and energy capture is the next step before environmental performance can be managed during the year.
Modular production capability 40 → 90
Muttenz is being designed around flexibility, and MTP adoption is one of the levers named in the company's own communications. Today, no CordenPharma site runs the kind of plug-and-produce environment the greenfield is intended to demonstrate.

Check this yourself

Our Service Portal has free self-assessments and market comparisons. These are the ones that line up with what we've read above — no sales call required.

Think we've read this right?

Talk to us

Related reading

This is an independent analysis prepared by A4BEE from publicly available information as of January 2026. It reflects A4BEE's own interpretation and opinion, is not affiliated with, endorsed by, or verified with CordenPharma International GmbH, and may be incomplete or inaccurate. All company names and trademarks are the property of their respective owners. To request a correction or removal, contact [email protected].