makeHistori - Empowering Biotech Manufacturing Through Intelligent Automation

Empowering Biotech Manufacturing Through Intelligent Automation

At makeHistori, we specialise in delivering advanced Process Control and Manufacturing Execution System (MES) solutions tailored specifically for the life sciences industry — with a deep focus on biotechnology and regulated manufacturing environments.

With decades of combined experience, we bring a unique blend of domain expertise, platform knowledge, and innovative thinking to every engagement.

Our Expertise

Process Control & MES Integration

We support end-to-end project delivery across process automation and MES landscapes. From initial user requirements through to validated functional specifications, we work in accordance with GAMP 5 and ISPE best practices, ensuring regulatory compliance and audit-readiness at every stage.

Our platform experience includes:

Emerson DeltaV for batch and continuous control
Emerson Syncade for MES, eBR, and material tracking
Siemens PCS 7 and Opcenter Execution Pharma
Integration with laboratory and business systems (LIMS, ERP, historians)

AWS-Enabled Digital Transformation

We help clients bridge the gap between traditional automation and cloud-native architecture by leveraging the AWS platform stack for:

Data historisation and contextualisation
Scalable, secure storage and analytics
Edge computing with Greengrass
Modern data lakes and event-driven pipelines

Our approach empowers life science manufacturers to unlock insights, enhance visibility, and enable rapid iteration — all within validated, GxP-compliant environments.

Protocol & Connectivity Solutions

Our team has extensive experience in designing and implementing robust data flows across:

Legacy OT protocols: OPC DA, OPC UA, Modbus, Profibus
Modern IIoT protocols: MQTT, Sparkplug B, REST APIs

We develop tailored architectures that bridge brownfield systems with modern cloud or on-premises platforms, preserving your existing investments while enabling future flexibility.

Digital Strategy & Architecture

We understand the critical trade-offs between:

Traditional Purdue Model architectures (ISA-95/88)

Modern Unified Namespace (UNS) and IIoT-driven models

Our consultants help you assess, plan, and implement architectures that suit your compliance, scalability, and digital maturity needs — without compromising data integrity or operational reliability.

Why Choose Us?

ISPE Member

We stay current with evolving industry standards and contribute to shaping best practices.

GAMP-Compliant Documentation

From URS to FAT/SAT and CSV, we provide structured and auditable deliverables.

Biotech-Focused

Our experience spans upstream and downstream processes, from fermentation to fill-finish.

Technology-Agnostic

We work across platforms and vendors, ensuring solutions are tailored to your operational reality — not constrained by product bias.

Let’s Build the Future of Biotech Manufacturing

We believe in combining industrial-grade engineering with modern digital tools to drive efficiency, traceability, and innovation in life sciences manufacturing.

Whether you’re upgrading legacy systems, designing a new facility, or implementing a cloud-based MES architecture — we’re here to help.

Email Us