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:
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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.
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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.
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.
