Case studies

Outcomes from engagements led by our directors

Real projects led by our directors. Client names and confidential details are withheld.

Two engineers checking a stainless steel bioreactor during validation testing — Photo by TECNIC Bioprocess Solutions on Unsplash

Operator in a full cleanroom suit working inside a sterile manufacturing area — Photo by TECNIC Bioprocess Solutions on Unsplash

Operational readiness, Biopharmaceuticals

Large scale fill finish facility start up

Challenge

A leading biopharmaceutical manufacturer needed full operational readiness support for a new aseptic vial filling line, including isolator integration, automation qualification and preparation for Therapeutic Goods Administration and US FDA inspection.

Approach

A senior team led by our director developed and executed an operational readiness master plan covering system readiness tracking, procedure development, training and pre approval inspection preparation.

Outcomes

Facility start up on schedule
First pass pre approval inspection
Zero critical deviations at launch
Full documentation suite completed
Operations team trained and certified

Laboratory technician inspecting an environmental monitoring plate — Photo by Toon Lambrechts on Unsplash

Process performance qualification recovery, Sterile injectables

Qualification programme recovery after a failed campaign

Challenge

A sterile injectable manufacturer experienced a failed process performance qualification campaign due to filling accuracy deviations and environmental monitoring excursions. The regulatory timeline was at risk.

Approach

Our director led a rapid root cause investigation that identified filling system parameter drift and air handling anomalies, then developed the corrective action programme and led the successful re execution of the campaign.

Outcomes

Root cause identified within two weeks
Corrective actions implemented and verified
Campaign completed successfully
Regulatory timeline maintained
No regulatory action taken

Commissioning and qualification, Biopharmaceuticals

SKAN isolator qualification programme

Challenge

A biopharmaceutical manufacturer required full qualification of a new SKAN isolator, including hydrogen peroxide decontamination cycle development, glove integrity testing and integration with the filling line.

Approach

Our director led the complete qualification programme from installation through performance qualification, developed the decontamination cycle and supported filling line integration and the Annex 1 compliance assessment.

Outcomes

Full qualification completed on schedule
Decontamination cycle validated to Annex 1
Filling line integration qualified
Annex 1 compliance confirmed
Regulatory submission package prepared

Bottles moving through an automated filling line — Photo by Mina Rad on Unsplash

Operational excellence, Biopharmaceuticals

More than one million euros in annual savings

Challenge

A leading biopharmaceutical manufacturer was losing significant equipment effectiveness on a high speed vial filling line, causing product waste, longer batch times and higher manufacturing cost.

Approach

Our director applied Lean Six Sigma methodology to find and remove the causes of loss. Key changes included high precision filling nozzles, optimised automated transport and design modifications driven by failure mode and effects analysis.

Outcomes

More than one million euros in annual savings
Equipment effectiveness up 18 percentage points
Batch cycle time reduced by 22 percent
Product waste eliminated
Improvement sustained

Operator working at a stainless steel bioreactor with an integrated control screen — Photo by TECNIC Bioprocess Solutions on Unsplash

Technology transfer, Biosimilars

Biosimilar technology transfer across three sites

Challenge

A global pharmaceutical company needed to transfer two liquid biosimilar products and seven lyophilised products onto retrofitted filling lines across several sites in Europe.

Approach

Our director led the engineering and transfer programme, managing process characterisation, equipment equivalency assessments, analytical method transfer and regulatory strategy across all three sites.

Outcomes

All products transferred
First commercial batches on schedule
Regulatory approvals maintained
Process knowledge fully documented
Teams trained at every site

Large industrial control room — Photo by Frantisek Duris on Unsplash

Digital manufacturing, Biopharmaceuticals

Predictive maintenance platform for global aseptic sites

Challenge

A global biopharmaceutical manufacturer needed one predictive maintenance and performance platform across several aseptic sites to reduce unplanned downtime and improve engineering compliance.

Approach

Our director developed analytics applications for global performance tracking, automated engineering compliance tools and capital replacement planning, drawing data from control systems across the sites.

Outcomes

Unplanned downtime reduced by 35 percent
Engineering compliance automated
Real time performance visibility across sites
Capital replacement planning optimised
Deployed across four global sites

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