Merck’s Ultra High Potent API Lab

The BioPharmaceutical Industry continues to rapidly advance with development of "cross modality" ultra potent compounds. This complex situation has required innovative thinking and approaches to traditional ways of working concerning scientific development, containment controls, and process design, engineering, and execution.

Merck's advancing pipeline requires a lab capable of delivering GMP quality, ultra-potent antibody drug conjugates (ADCs). As with many of our clients, to do so in a rapid manner meant retrofitting existing space/equipment while delivering the latest containment equipment capable of protecting both the person and the product ("dual simultaneous containment" within one facility). This challenge increased exponentially as we were faced with severe spatial constraints and numerous supply chain issues.

To ensure "right first time" success we had to work smarter and harder! This meant our design approach was striving for perfect communication through visualization tools. This occurred in many forms such as: Teams virtual project meetings, Factory virtual tours via Hololens, Active Virtual development and design reviews, and numerous iterations of 3D models throughout the entire project lifecycle.

This novel approach ensured a seamless transfer of information amongst end users, designers, engineers, equipment fabricators, constructors, and all compliance entities (safety, quality, maintenance, etc.). It also enabled benefits such as "precision installation", expedited protocol development, and augmentation of client's staff to expedite front runs and "final set-ups".

Key features enhanced through our novel approach:

  • Extremely compact modular, remote monitored refrigeration and - 80C freeze storage
  • Reduced need for maintenance entry into potent space: maximized remote HEPA Filter testing, instrument testing, automation and HVAC diagnostics and repairs
  • Compact rigid isolators (subdivision, weighing, samples ..), and flexible isolator (lyophilization) capable of < 10ng/m3 containment while maintaining Grade C status and designed for all support components to be properly located to ensure maximum hygienics
  • Novel fume hoods allowing handling of harsh chemistries while mitigating risk of a potent compound drying, aerosolizing, and proliferating
  • Compact hygienic benchtop and casework for consumables, HPLC, UPLC, and non potent ventilated enclosure
  • Compact hygienic large storage area for dedicated large equipment, ladders, PPE, etc.
  • Visual line of site with audible intercoms to enable SAFE interactions of support staff in corridor with operating staff in Potent Space
  • Clever visual and audible design and implementation of the numerous required safety alarms
  • "Precision Installation" enabling extremely compact equipment layout, personnel movement, componentry location, and hygienic sustainability
  • Lastly, optimal implementation and sustainability of tiered containment approach from primary through quaternary protection within both a facility Grade D space and containment isolators Grade C space