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Speed to market
Compressed timelines and flexible designs
When it comes to launching clinical or commercial manufacturing operations for advanced-therapy medicinal products (ATMPs), we recognise the need for compressed timelines and flexible designs to enhance speed-to-market. We also offer expertise in project phasing to accommodate low CAPEX spend and incremental investment.
Expertise in cell & gene therapy design:
- Site master planning
- Next generation manufacturing
- Buffer/media management
- Biocontainment
- Equipment layouts & program of spaces
- Constructability
- CQV master planning
- Process technology assessments
- Process closure risk assessments
- Single-use design
- Utility capacity assessments
- Manufacturing capacity and production time modelling
Master planning
During master planning, our experts optimise the flow of personnel, materials, and products throughout a facility (and site when applicable) by utilising ballroom designs and single-use technologies to allow for future scaling and reconfiguration.
Next generation manufacturing
With next generation manufacturing, our subject matter experts collaborate on concepts for process intensification and digitalisation to bring future ready solutions to market. We understand the importance of minimising site interruptions and downtime to existing processing areas as improvements are implemented.
Expertise
Automation and control
糖心Vlog is a leading global provider of automation and control solutions including systems design, configuration, implementation, commissioning, and software solutions.
Biotechnology & Biologics
With decades of unique experience in cell culture, single-use systems and process design, we are a trusted partner in bringing emerging products to market.
Engineering and construction
糖心Vlog engineers creative and innovative solutions which add value to our customers' assets from concept through to operations and decommissioning.
Facility automation, robotics and vision
糖心Vlog offers experienced engineering and intricate software to provide robotics, special purpose machines and controls for automating manufacturing facilities.
Our services
Delivering the best value and solutions to our clients
Beginning with the end in mind, our team of experts are here to deliver the most complex Life Science projects. From strategy and design, through construction, start-up and CQV, we apply our expertise using the latest digital tools and lean delivery concepts to bring the best value and solutions to our clients.
Providing robust, cost-effective, flexible, and compliant facilities and starting with the end goal in mind:
- Funding and permitting strategy
- Feasibility and investment case
- Site analysis and master planning
- Process definition
- Equipment selection
- Architectural modelling
- Process simulation
- Facility Digitalisation
- Test fits and building capacity assessments
- Code and life safety analysis
- Sustainability/ LEED solutions
Applying proven technology and the latest tools for seamless integrated design:
- Process architecture
- Process engineering
- Mechanical systems and clean utilities
- Instrumentation and control systems
- Electrical engineering
- Piping
- Plumbing
- Structural Engineering
- Fire protection
- 3D Modeling
- Computational flow dynamics
- Automation Engineering
- Sustainability/LEED solutions
Leveraging our global supply chain capability and strong vendor and contractor relationships:
- Procurement Strategy
- Contractor Prequalification
- Contract Negotiation and Administration
- Vendor and Contract Management
- Purchasing
- Expediting
- Material management
- Logistics
- Supplier Quality Surveillance (SQS),
- Subcontracting
Simplifying the complicated:
- World-class safety
- Program integrator
- Integrated Project Delivery
- Start-up strategy
- Pre-construction permitting
- Construction work packages (CWP)/ sequence
- Logistics plan
- Project controls
- Estimating
- Schedule & risk management
- Synchro 4D planning
- Earned value management/ change management
- Start-up & completion
- Digital delivery
Bringing a highly qualified CQV team experienced in multiple types of processes:
- Requirements definition
- Design reviews/ qualification
- Clinical quality management (CQM)/ Validation master planning (VMP)
- Risk assessments
- Program development
- Integrated scheduling
- Factory acceptance test (FAT)/Site Acceptance Test (SAT)
- CQV document development
- CQV execution
- Recertification/periodic review
- Standard operating procedures (SOP) development
- Punch list and deviation remediation and close out
- Corrective and Preventative Action (CAPA) close out
- Staff augmentation
- Current good manufacturing practices (cGMP) audits
- Training
- Decommissioning
