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.
Contact Us TodayWe 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:
We help clients bridge the gap between traditional automation and cloud-native architecture by leveraging the AWS platform stack for:
Our approach empowers life science manufacturers to unlock insights, enhance visibility, and enable rapid iteration — all within validated, GxP-compliant environments.
Our team has extensive experience in designing and implementing robust data flows across:
We develop tailored architectures that bridge brownfield systems with modern cloud or on-premises platforms, preserving your existing investments while enabling future flexibility.
We understand the critical trade-offs between:
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.
We stay current with evolving industry standards and contribute to shaping best practices.
From URS to FAT/SAT and CSV, we provide structured and auditable deliverables.
Our experience spans upstream and downstream processes, from fermentation to fill-finish.
We work across platforms and vendors, ensuring solutions are tailored to your operational reality — not constrained by product bias.
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.
Contact us today to discuss how we can support your next project.
Email Us