CSBio

CSBio, founded in 1993 and headquartered in Silicon Valley, is the leading global provider of peptide synthesizers serving production laboratories and pharmaceutical companies worldwide. While its proprietary C++-based control system served research and pilot-scale systems well — supporting reaction vessels from 200ml to 5L — commercial-scale customers operating vessels up to 800L required far deeper integration. Pharmaceutical manufacturers needed the synthesizer to connect with plant-wide MES systems, support IIoT architectures, and comply with 21 CFR Part 11 requirements for electronic records and signatures. The proprietary platform could not meet these demands, leaving commercial customers without the process visibility, material traceability, and audit-ready electronic batch records that regulated pharmaceutical environments require.

CSBio engaged Rockwell Automation LifecycleIQ Services to design and build a replacement control platform based on the PlantPAx distributed control system (DCS) — leveraging Allen-Bradley hardware and FactoryTalk software. The platform was configured to manage all batch operations, recipe development, batch reporting, and instrumentation across the synthesizer skid. EtherNet/IP serves as the backbone network, with OPC UA communications layered on top to enable standardized, vendor-neutral connectivity to enterprise systems, MES platforms, and IIoT solutions. IoT-connected instrumentation and valve integration provide real-time process visibility at the component level — including motor-level control — which commercial pharmaceutical customers require to meet cGMP process monitoring standards. CSBio first deployed the platform in 2021 and has continued refining it in an ongoing partnership with Rockwell Automation.

The PlantPAx-based platform delivers plant-wide integration that CSBio's proprietary system could not provide, enabling commercial-scale pharmaceutical customers to operate peptide synthesizers within modern industrial control architectures. Key outcomes include:

• 21 CFR Part 11 compliance built into the control layer — electronic batch records and electronic signatures are native to the system, eliminating costly post-deployment compliance retrofits
• MES integration enables raw material inventory management and end-to-end material traceability throughout the synthesis process, with direct ties to quality management systems
• Scalable instrumentation — the architecture expands to include additional tanks and sensors as production demands grow
• Ongoing platform refinement since 2021 ensures the system evolves with customer and regulatory requirements

• Pharmaceutical OEMs operating at commercial scale cannot rely on proprietary control systems — open DCS architectures with standard protocols (EtherNet/IP, OPC UA) are the baseline expectation
• Building 21 CFR Part 11 compliance into the control platform from the start is significantly more cost-effective than retrofitting electronic records capabilities later
• MES connectivity unlocks traceability and quality management integration that regulators and enterprise customers increasingly require
• Transitioning from a proprietary codebase (C++) to a DCS platform is technically challenging — engaging the DCS vendor directly to build the initial platform reduces risk
• Ongoing refinement partnerships are more valuable than one-time deployments in regulated industries where requirements continuously evolve