Employee Owned.
Employee Driven.

Uniquely comprised of GMP operations professionals, ABIO strives to engage, understand and represent client needs from concept into operational readiness.

About ABIO

About ABIO

ABIO 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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Services

ABIO Provides You with the Quality Consulting Services You Need

Project Management Consulting

ABIO engages clients and represents their needs in diverse GMP environments while keeping the client’s best interests in mind. Our core strength and passion consists of effective strategy development and strong project management principles that ensure client requirements are met from concept to operational readiness.

  • Scope and requirements development
  • Project execution planning
  • Schedule development, management and reporting
  • Budget generation, management and reporting
  • Resource planning
  • Design phase management
  • Execution planning
  • Procurement services (pre-qualification, RFP, technical bid review, etc.)
  • Start-up and commissioning
  • C&Q coordination and support
  • Operational readiness planning and management

Project Controls

Project success is rooted in effective project controls, including budget, schedule and risk management. Our expansive project management toolbox is customizable to your project needs and allows us to effectively manage and report status and metrics, while maintaining delivery to scope, budget, and schedule.

  • Schedule planning, monitoring, and control
  • Budget development, and control
  • Routine status / metric reporting
  • Risk identification, assessment, and monitoring
  • Scope / change monitoring and control

Process & Operational Consulting 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, ABIO works directly with your teams, leveraging our extensive life sciences and CGMP operational experience to meet your goals.

  • Feasibility studies (facilities, capital investment)
  • Process requirements definition and development
  • Process flow diagrams and material balances
  • Process risk assessment
  • Time & Motion Studies
  • Startup and CQV support
  • SOP/BR generation and review
  • Staff training
  • Business process planning and support
  • Investigation and remediation management
  • Automation and controls integration planning and management

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 management consulting
  • Facility life cycle assessments and planning
  • Capital budget / portfolio planning and management
  • Budgeting and resource planning
  • Preventive maintenance planning
  • Maintenance program generation
  • Facilities and equipment risk assessments
  • Spares parts program assessments and planning
  • Facility program auditing
  • Compliance, gap assessment, inspection readiness
  • Compliance remediation

Technical Recruiting

Selecting the right talent to fill a critical role in the competitive life sciences space is no easy task. Many recruiters simply match up key terms to your job description and send over a stack of resumes. Our owner's side experience in CGMP operations, support functions, and workforce development allows us to read deeper into candidates and find that hidden gem.

ABIO has created a systematic process that identifies qualified talent for every position you need to fill. Our system of identification and engagement ensures the widest and most applicable net is cast for your specific role.

Commissioning & Qualification

Commissioning and qualification activities are critical to achieving an operationally ready and compliant CGMP facility. ABIO integrates CQV strategy development and planning into an overall execution plan to ensure seamless transition from construction through operational readiness.

  • Commissioning, qualification, and validation (CQV) master planning, preparation, and execution
  • Process quality risk assessments
  • Design qualification (DQ)
  • FAT/SAT planning and execution support
  • Turnover Package (TOP) review
  • CQV protocol development and field execution (FAT to PQ)
  • Facility and process startup support
  • Single Use Technology validation
  • Automation qualification
  • Computer systems validation
  • Cleaning validation

Featured Projects

ABIO 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.

projects
Careers

Work With Us

ABIO 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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