When Quality Is Your Top Priority

Exceptional project and process capabilities leveraging over 200 years of biopharma operations and capital projects experience, A-BIO provides best-in-class consulting services for:

  • Owners' Project Management
  • Capital Portfolio and Project Management
  • Process Engineering
  • Operational and Technical Services
  • Facilities Services

Modalities Served

Our services focus on what we consider to be the heart of all biopharma facilities. Whether an existing or future facility, everything revolves around the process

The processes that we specialize in include:   

About A-BIO

About A-BIO

A-BIO has been serving the life sciences (GMP facilities and operations) sector since 2014, helping clients effectively define and meet their goals for capital project execution and operational readiness.  We leverage decades of owner's-side experience to identify the right resources and expertise to support your needs. Whether as GMP owner's representatives or technical/operational consultants, our diverse and growing team will endeavor to exceed your expectations.

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A-BIO Provides You with the Quality Consulting Services You Need

Owner's Project Management &
Capital Delivery

A-BIO engages clients and represents their needs in diverse GMP environments while keeping the client’s best interests in mind. Capital projects require effective strategy development and strong project management principles to ensure client requirements are met from concept through operational readiness.

  • Front-end Project Strategy Development
  • Capital Portfolio and Project Management
  • Scope and Requirements Development
  • Project Execution Planning
  • Schedule Development, Management and Reporting
  • Budget Generation, Management and Reporting
  • Resource Planning
  • Design Phase Management
  • Procurement Services (Pre-qualification, RFP, Technical Bid Review, etc.)
  • CQV Strategy and Coordination
  • Operational Readiness Planning and Management

Process Engineering

Process is at the heart of all biopharma manufacturing facilities. Facilities and equipment must be appropriately designed to support process needs ensuring quality and efficient operations. A-BIO’s team of specialists and engineers are best-in-class with extensive process engineering experience executing projects within existing and new cGMP production facilities. 

  • Feasibility Studies (Process Systems, and Clean Room Design)
  • Data Collection and Analysis
  • Process Requirements Definition and User Requirements Specifications
  • Process Flow Diagrams and Material Balances
  • Process Risk Assessment
  • Tech Transfer and Scale Up
  • Equipment Design, Sizing, and Specification
  • System Design and Equipment Layouts
  • Single-use Consumables Design and Vendor Coordination
  • Instrumentation Specification
  • Process Simulation
  • Automation and Control Integration Planning and Management

Operational and Technical Services

In fast-paced project and operational environments, your organization's success depends on reliable technical expertise and delivery. Whether supporting facilities, automation, supply chain or operational efforts, A-BIO works directly with your teams, leveraging our extensive life sciences and cGMP operational experience to meet your goals.

  • Feasibility Studies (Facilities, Capital investment)
  • Risk Assessments
  • Facility Capacity Assessments
  • Equipment Procurement Services
  • Startup and CQV Support
  • SOP/Batch Record Generation and Review
  • Business Process Planning and Support
  • Investigation and Remediation Management
  • Compliance Gap Assessment

Facilities Services

GMP facilities require a high-level of quality and control to ensure compliance with regulatory expectations and avoid unplanned business interruptions. Our extensive owner’s side experience with facilities operations and audits (regulatory and client) puts us in a unique position to assess and ensure your facility operations programs are robust, compliant, and aligned with the needs of the business.

  • Facility Life Cycle Assessments and Planning
  • Capital Budget / Portfolio Planning and Management
  • Facility Shutdown Planning, Scheduling and Management
  • Operational Budgeting and Resource Planning
  • Preventive Maintenance Planning
  • Facilities and Equipment Risk Assessments
  • Spare Parts Program Assessments and Planning

Technical Scheduling and Project Controls

A-BIO understands that a strong technical schedule and project controls can set the framework for a project’s execution. A deep understanding of project management and execution in the life sciences industry ensures that schedules are robustly built to provide projects with functionality that fits the objective. When paired with custom tools schedules provide project managers with the ability to be proactive in their execution.

  • Capital Project Integrated Schedule Development and Management
  • Custom Reporting Tool Development and Management
  • Critical Path Definition and Analysis
  • Project Budget Development, Management and Reporting
  • Shutdown Schedule Development and Management
  • Project/Initiative Execution Flowcharting
  • Schedule Risk Analysis
  • Cash Flow Projection, Management, and Reporting

Technical Operations On-Call Services

Depend on our retained services for immediate operational needs without any upfront costs. Our customizable service agreements ensure you pay only when services are requested or rendered. We offer comprehensive support including investigations, equipment and automation troubleshooting, deviation/observation responses, and general operations support. Trust us to keep your operations running smoothly, around the clock.

  • Retained Services for Immediate Needs
  • No Cost Unless Services Rendered
  • Equipment Troubleshooting
  • Deviation/Observation Responses
  • Investigation Management and Support
  • Automaton Troubleshooting
  • Operations Support

Featured Projects

A-BIO plans and executes projects for both capital investments and operational initiatives, large and small. Our toolkit is adaptable to client and project-specific needs, allowing us to service a wide range of project types.

COVID Manufacturing Facility Start-Up

Project management and technical services consulting for fast-paced COVID-19 manufacturing facility start-up. Provided day-to-day planning and coordination for equipment procurement, installation, validation, and operational readiness.

Run Rate Optimization Project

Led development of process simulation model using SchedulePro software for multi-product clinical/commercial facility to identify constraints for increasing batch cadence by 70%. Identified scope and led projects to eliminate identified constraints, including improvements to buffer handling, WFI storage/distribution, process waste, and process glycol capabilities.

Large-scale Bioreactor Retrofit

Served as owner's project manager for the design, execution, automation, and qualification of two bioreactor trains to address microbial control issues and improve reliability. Project consisted of improvements for two seed trains and a complete rebuild of the production reactors (4 x 15,000L) while maintaining one train in production at all times. Total capital investment of $20M.


Join the A-Team

A-BIO works on diverse and ever-changing projects. We strive to match the right resources to the right job, thereby ensuring continued quality service delivery. If you think you would be a great fit for our team, don't hesitate to submit your resume below and start the conversation.

Current Openings

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