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Bright Peak Therapeutics

Scaling a 300-step chemical synthesis from bench to clinic

Industry
Biotechnology
Headquarters
Allschwil, Basel-Landschaft, Switzerland
Public information as of
January 2026

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

Strategic priorities

Bright Peak Therapeutics was founded in 2017 as a spin-out from ETH Zürich and operates from the Switzerland Innovation Park Basel Area, with North American clinical development based in Del Mar, California. The company describes its work as 'cell-free' protein production: rather than expressing biologics in living cells, it builds them chemically through a process the CTO has publicly described as more than 300 individual reaction steps. In June 2024 the company closed a $90 million Series C led by Johnson & Johnson Innovation to advance its lead candidate BPT567 — a first-in-class PD1-IL18 immunoconjugate — into Phase 1/2a trials.

The first patient was dosed in October 2024 under the SUMMIT-1 study. Because BPT567 has no established regulatory comparator for its specific conjugation mechanism, the FDA submission file (the Chemistry, Manufacturing and Controls, or CMC, package) has to demonstrate reproducibility of the entire 300-step synthesis from primary data. Doing that on paper-based and USB-transferred records is the load-bearing documentation problem of the program.

Bright Peak raised more than $232 million across the Series A ($35M, 2020), Series B ($107M, 2021) and Series C ($90M, 2024), with RA Capital and Versant Ventures as additional significant investors. The Series C investors publicly framed the round as preparation for industrial-scale production. The lead program is moving into clinical supply, the transatlantic footprint is fixed, and the absence of a Chief Information Officer or equivalent digital lead means technology choices have so far been made inside individual R&D projects.

The operational priorities that follow are concrete: turning the 300-step process from a manual sequence into a controlled, recorded one; moving synthesis data out of USB sticks and paper logs and into a shared model that Basel R&D and San Diego clinical operations can read; assembling CMC evidence as a by-product of running the process rather than as a separate documentation effort; and giving the modular synthesis recipe a portable form so the same recipe can be executed at a CDMO site without re-engineering.

Challenges we see

  • Operations Manufacturing

    Running 300+ synthesis steps inside a controlled envelope

    Bright Peak's designer cytokines are built chemically rather than expressed biologically. The CTO has publicly stated the process takes 'over 300 chemical steps,' and the company itself describes this work as more complex than any prior pharmaceutical synthesis attempted at scale. Each step carries temperature, pressure, reagent-dose and time variables that affect what comes out at the end.

    When the operating envelope of each step is set and checked manually, a small drift early in the run is invisible until much later in the batch. Reading critical parameters continuously and bounding each step against an expected range turns those drifts into signals that can be acted on while the batch is still running.

  • Operations Manufacturing

    Scaling from benchtop R&D to kilogram clinical supply

    First-in-human material has to be produced at kilogram scale, whereas the R&D process was developed at milligram scale on benchtop synthesizers and mixers. Fluid dynamics, mixing efficiency and heat transfer behave differently at the larger scale, and benchtop equipment was not built to expose its parameters for external control.

    Where the pilot-scale synthesis is still operated as a larger copy of the benchtop process, scale-dependent variables become harder to manage. Treating scale-up as a control-engineering problem rather than as a hardware problem lets the same recipe be re-tuned for the larger vessel.

  • Digital Integration

    Moving synthesis data between Basel and San Diego without manual transfer

    Basel laboratories run synthesizers, HPLC (High-Performance Liquid Chromatography) and mass spectrometers from multiple manufacturers, each with its own data format. San Diego clinical and regulatory staff need near-real-time access to the same numbers. Today the data moves by USB stick or paper log, and IT (information technology) and OT (operational technology) systems operate separately.

    Where batch data only reaches the next site through manual transfer, reconciliation happens late and after decisions have been made. Streaming the data into a shared model lets Basel and San Diego read the same batch at the same time, with the audit trail of who changed what intact.

  • Compliance Regulatory

    Producing CMC evidence for a modality with no comparator

    BPT567 is a first-in-class PD1-IL18 immunoconjugate: there is no prior approved product with the same conjugation mechanism to reference. The FDA's CMC package for the molecule therefore has to demonstrate reproducibility of the 300-step synthesis from primary data, and the company has publicly named a Vice President of CMC responsible for accelerated CMC development. The first patient was dosed in October 2024, which puts the IND-enabling and BLA-preparation documentation on an active timeline.

    Where CMC evidence is assembled from logs and spreadsheets after the synthesis is run, the documentation step grows with each batch and review cycles lengthen. Capturing the same evidence as a by-product of the synthesis itself keeps the documentation load proportional to the batches, not to the people available to write it up.

  • Digital Security

    Sharing synthesis protocols between sites without weakening controls

    KAHA ligation and the EDC (Enhanced Delivery Conjugation) platform protocols are the company's core intellectual property. They have to be available to authorised Basel R&D and San Diego clinical staff across a transatlantic network, while remaining inaccessible to anyone else. The company does not currently have a Chief Information Officer or Head of Digital, which means the security architecture has so far been assembled project by project.

    Where access to synthesis protocols is granted by network location rather than by identity, every remote-access path is also a path to the protocols. An identity-based access model with documented trust boundaries lets the same protocols travel across the transatlantic link without broadening who can read them.

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. Closed-loop control of critical synthesis parameters

    Bright Peak's 300-step chemical synthesis is operated largely as a manual sequence, with each temperature, pressure and reagent dose set and verified by hand. The process is more complex than any prior pharmaceutical synthesis the company has publicly compared itself to.

    Instrumenting the reactors and running closed-loop control on critical parameters, with the operating envelope written into the recipe, lets each step hold its own range and produces a continuous record that the same recipe was executed as written.

    • ETH Zürich profile of a Bright Peak co-founder, 2021
    • Bright Peak Therapeutics About page, accessed 2026

  2. Streaming Basel synthesis data to San Diego clinical operations

    Basel equipment data lives in instrument-specific files, and San Diego clinical and regulatory staff currently read batch status through manual reports. The transatlantic footprint is fixed, but the IT and OT sides of the network do not yet share a data model.

    An industrial data platform with OPC UA (Open Platform Communications Unified Architecture) connectors at the equipment edge and a shared cloud-side model lets Basel and San Diego read the same batch, with the audit trail intact, instead of reconciling two views of the same run.

    • Bright Peak Therapeutics Series C announcement, June 2024
    • Bright Peak Therapeutics Contact page, accessed 2026

  3. Producing CMC evidence as a by-product of running the synthesis

    The 300-step synthesis is a first-in-class modality, so the FDA CMC submission has to demonstrate reproducibility from primary data. With paper logbooks and USB transfer, the CMC package is currently assembled after the fact.

    A GAMP 5 (Good Automated Manufacturing Practice, the ISPE guidance for validated laboratory and manufacturing systems) compliant paperless lab environment that captures each step's parameters and results at the instrument, and writes them into the batch record with their audit trail, makes the CMC evidence a by-product of running the synthesis.

    • Bright Peak Therapeutics Series C announcement, June 2024
    • Bright Peak profile of the VP CMC, accessed 2026

  4. Identity-based access for synthesis protocols across the transatlantic link

    KAHA ligation and EDC conjugation protocols are the company's core intellectual property and have to be readable by authorised Basel R&D and San Diego clinical staff. The current remote-access architecture was assembled project by project, and the leadership chart has no CIO or equivalent digital lead.

    An identity-based access model with documented trust boundaries, verified session-by-session, lets the same synthesis protocols be shared across the transatlantic link without broadening who can read them, and gives auditors a single source of truth for who saw what and when.

    • Bright Peak Therapeutics company profile on The Org, accessed 2026
    • Bright Peak Therapeutics Series C announcement, June 2024

  5. Portable synthesis recipes for CDMO replication

    The same 300-step synthesis has to run at clinical scale and, eventually, at commercial scale. The benchtop R&D equipment the recipe was developed on was not built to expose its parameters in a portable form.

    An MTP (Module Type Package, a vendor-neutral standard for describing process module capabilities so any controller can drive any module) service model that wraps each unit operation — mix, heat, ligate, react — lets the synthesis recipe be expressed once and re-run at a CDMO site on compatible modules, without re-deriving the know-how.

    • Bright Peak Therapeutics About page, accessed 2026
    • Bright Peak profile of the VP CMC, accessed 2026

What we'd propose

  • Digital CDMO

    Closed-loop synthesis control for the 300-step process

    We instrument the synthesis reactors, capture temperature, pressure and reagent-dose parameters continuously, and run closed-loop control against a per-step operating envelope, so the same recipe produces a continuous record of how it was executed.

    • Reactor instrumentation

      Getting data off the synthesis rig

      Add sensors and OPC UA (Open Platform Communications Unified Architecture) interfaces to the synthesis reactors, mixers and dosing units so critical parameters leave the equipment in a documented, vendor-neutral form rather than staying inside the controller.

    • Per-step operating envelope

      A range for each step

      Define the expected range for each of the 300+ synthesis steps from historical runs, then check the live batch against that range so a drift in step 247 is visible in step 247, not in the final product test.

    • Batch process record

      The run written down as it happens

      Write each monitored parameter and operator action into a per-batch record with lineage back to the instrument that produced it, so the recipe execution and the evidence trail are the same artifact.

    • Each of the 300+ steps is checked against its own range while the batch is still running.
    • The same recipe, run by different operators, produces the same recorded evidence.
    • The batch record and the regulatory record are the same artifact.

    We've done this before

    See how we do Digital CDMO
  • Digital Lab

    Basel to San Diego data integration on a shared model

    An industrial data platform that connects Basel synthesis equipment to a shared cloud-side model and exposes the same view to San Diego clinical and regulatory staff, with role-based access and audit trail intact.

    • OPC UA equipment edge

      Vendor-neutral data off instruments

      Connect synthesizers, HPLC (High-Performance Liquid Chromatography) and mass spectrometers through OPC UA so each instrument's data leaves the lab in a single, documented form rather than a different format per vendor.

    • Shared batch model

      One batch, one record

      Define the entities both sides care about — batch, step, parameter, deviation, result — once, and load both Basel and San Diego data against that model so the two sites read the same batch.

    • Role-based dashboards

      Each role sees what it needs

      Expose the shared model through dashboards that show Basel operators the step-level view and San Diego clinical staff the batch-level view, with role-based access control and a per-user audit trail.

    • Basel and San Diego read the same batch, instead of reconciling two views of it.
    • USB transfers and paper logs leave the workflow, with the data lineage intact.
    • Clinical and regulatory staff answer questions from the same model the operators are using.

    We've done this before

    See how we do Digital Lab
  • Enterprise AI

    Paperless CMC evidence chain for the BPT567 submission

    A GAMP 5 compliant laboratory execution layer that captures each synthesis step's parameters and results at the instrument, writes them into the batch record with their audit trail, and assembles the CMC (Chemistry, Manufacturing and Controls) submission directly from that record.

    • Validated paperless workflows

      Logbooks become system records

      Replace paper logbooks and ad-hoc spreadsheets with validated digital workflows that capture data at source, enforce ALCOA+ (the data integrity principles of Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring and Available) at the point of entry, and make every change attributable to a named user.

    • Equipment-to-LIMS data flow

      Results reach the LIMS as data

      Stream synthesis equipment output into the LIMS (Laboratory Information Management System) and ELN (Electronic Lab Notebook) with schema validation at the boundary, so analytical results and process parameters arrive with their instrument identity and timestamp attached.

    • CMC submission package assembly

      The dossier builds itself

      Compile the CMC submission package directly from the validated batch record, so the documentation is generated from the run rather than reconstructed after it.

    • CMC evidence is produced as part of the synthesis run, not assembled after it.
    • Each number in the submission can be traced to the analytical run that produced it.
    • The same record serves the laboratory, the regulatory submission and the inspector.

    We've done this before

    See how we do Enterprise AI
  • Agents

    AI agents for CMC and regulatory document work

    Narrow, reviewable agents that take the repetitive part of document work for a first-in-class modality: drafting CMC summaries from the validated batch record, checking a submitted document against its template before human review, and finding every controlled document a standards change affects. A named person approves every output.

    • Drafting from the batch record

      First drafts from system data

      Generate the first draft of a CMC summary, deviation write-up or periodic review from the validated batch record, so the author edits and judges rather than assembles from logs and spreadsheets.

    • Template and completeness checking

      Gaps found before review

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

    • Change impact across the controlled document set

      Which documents a change touches

      When a standard, method 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.

    • Document review queues move faster because documents arrive complete.
    • The scope of a standards change is established by search rather than by recollection.
    • Every agent 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 CDMO

    MTP-based modular synthesis skids for CDMO replication

    A modular automation package that wraps each synthesis unit operation as an MTP (Module Type Package) service, so the same 300-step recipe can be executed at a CDMO site or a new Bright Peak facility on compatible modules, without re-deriving the know-how.

    • MTP service definitions per unit operation

      Each step becomes a service

      Define the high-level services for each synthesis unit — mix, heat, ligate, react — in the MTP standard so a controller can drive any compatible module, regardless of vendor.

    • Process orchestration layer

      One recipe, many modules

      Implement a process orchestrator that sequences the 300 MTP services in the right order, passing batch context between them, so the recipe is defined once and re-runnable on any compliant module set.

    • Validated deployment templates

      The recipe travels intact

      Package the validated recipe, the MTP service set and the qualification evidence into a deployment template that can be installed at a CDMO site or new facility within days, with the recipe unchanged.

    • The synthesis recipe travels as data, not as a re-engineering project.
    • Vendor selection for the CDMO site is decoupled from the recipe itself.
    • The same recipe, qualified once, can be re-qualified at each new site in days rather than months.

    We've done this before

    See how we do Digital CDMO

Digital maturity: today and target

Scored out of 100 across six dimensions. The target is what Bright Peak Therapeutics's own published ambition implies — not a perfect score.

Source: A4BEE analysis of public sources
Process Automation 25 → 80
The 300-step synthesis is operated largely as a manual sequence, with each step's critical parameters set and checked by hand. The target state is closed-loop control on those parameters, with the operating envelope captured in the recipe.
Data Integration 20 → 85
Basel equipment runs in instrument-specific silos, and data moves to San Diego by USB or paper log. The target state is a shared industrial data platform that both sites read against the same model.
Regulatory Compliance 35 → 90
CMC evidence for a first-in-class modality is currently assembled from logs after the synthesis runs. The target state is GAMP 5 compliant paperless workflows with the CMC package generated from the validated batch record.
Cybersecurity Posture 30 → 80
The synthesis protocols are accessed through a remote-access architecture assembled project by project, with no CIO or equivalent digital lead. The target state is an identity-based access model with documented trust boundaries.
Manufacturing Scalability 18 → 75
The benchtop R&D equipment the recipe was developed on was not built to expose its parameters in a portable form. The target state is MTP-wrapped unit operations and a portable recipe that can run on any compliant module set.
Real-Time Visibility 22 → 85
San Diego clinical and regulatory staff currently read batch status through manual reports. The target state is near-real-time dashboards that show the same batch the operators in Basel are working on.

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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 Bright Peak Therapeutics, 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].