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