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Built for the process. Built to last.

Peak Biotech designs chromatography systems for high-value biologics and complex API production. These are processes where standard solutions fall short and long-term reliability is a production requirement.

Systems

Production-scale chromatography carries consequences that stretch over decades. When the process is complex and the molecule is valuable, standard platforms introduce performance gaps that show up years into production: yield loss, requalification cycles, and unplanned downtime.

 

Peak Biotech builds systems around your process requirements, not around a standard catalogue. Every system leaves our facility fully tested, documented, and ready for qualification.

 

Systems Engineered Around the Column

Designed to support stable operating conditions.

Built for Long-term GMP Operation
Reliable operation across repeated production campaigns.

Compact and Practical System Design

Built for retrofit and operational facility realities.

Engineering Continuity from Design to Operation
Direct engineering involvement throughout the project lifecycle.

Three Pressure Classes

Whether you are running a large-scale protein capture step or a high-resolution separation at 100 bar, Peak Biotech configures the system around your flow rate, column type, and process context. All systems are available in gradient, step, or isocratic configuration.

Specification table:

  Low Pressure Medium Pressure High Pressure
Operating Range 0 - 6 bar 0 - 30 bar 0 - 100 bar
Flow Rate 6 - 5,000 l/h 6 - 5,000 l/h 6 - 1,000 l/h
Gradient Control Conductivity Feedback NIR, Mass or Conductivity NIR, Mass or Conductivity
Sealing Material PTFE or EPMD PTFE PTFE
Construction Material 1.4404, 1.4435, SS316L 1.4404, 1.4435, SS316L 1.4404, 1.4435, SS316L

 

Configured for Your Process

No two processes are identical. Peak Biotech systems are configured around what your process actually requires. The starting point is your process, and the system follows from there.

Common configurations include in-line filter modules, heat exchangers, recycle loops, sample injection loops, additional buffer inlets up to 6, fraction collection up to 9 outlets, nitrogen blanketing, and ATEX / Class One Div 2 for explosion-proof environments.

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PeakChrom: Control Software for GMP Production

Process control and data integrity in one platform.

PeakChrom handles batch sequencing, recipe management, and fraction collection logic. It is CFR Part 11 and GAMP 5 compliant, programmed to S88 standard, and fully tested and validated before delivery.

Fraction triggers can be set on UV peak, UV slope, volume, time, CV, or percentage of peak. Recipes are edited graphically and run automatically. Batch reports are generated without manual input.

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Ready for Qualification from Day One

Every system is delivered with a full documentation package.

Delivered documentation includes PI-diagrams, component lists, electric schematics, material certificates, CE and ATEX certificates, and a user manual.

FAT is performed before shipment. IQ/OQ protocols are available as standard.

 

Documentation Test and Qualification
Product Specification Project Quality Plan
PI-Diagram Function Test Plan and Performance
Component List + Electric Schematics FAT Performed before Shipment
Material Certificates SAT On-site Performance
CE and ATEX Certificates IQ / OQ Document and Performance
User Manual + Traceability Matrix Software Test Records

 

 

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Your process defines the system. We build around what it actually requires.

If you are at the stage where downstream purification is being defined, we welcome an early technical conversation.