owner’s project management (opm)...

Capitalize on your investment with confidence.

Amidst countless technical and regulatory project requirements, your best value and Great Manufacturing Performance are secured when owner expectations are represented by the right expertise.

©2016 alliancebio, llc WASHINGTON, D.C. METRO AREA www.alliancebio.us

Capital allocated for any biopharm project is an investment in the organizational vision and accompanied by unique

expectations and needs. These hold equal importance to a litany of industry standards. With complex projects and

multiple design and construction partners, the best bet for success is an expert advocate.

Comprised of capital project and engineering professionals, alliancebio works directly with partners and client

teams for a seamless transition from project into production. From support in initial scope/budget definition to

expert oversight for execution and delivery, our priority is your confidence in a high-performing project.

OWNER’S PROJECT MANAGEMENT (OPM) PLATFORM

PROJECT MANAGEMENT

ENGINEERING PROCUREMENT CONSTRUCTION MANAGEMENT

STARTUP AND

COMMISSION-ING

FACILITIES OPERATIONS


PROJECT MANAGEMENT

Specializing in the management of life sciences projects, the alliancebio team ensures your project is delivered per scope, on time and within budget. Our expertise covers all phases from conceptual design through mechanical com-pletion and qualification. PM services include:

� Customized work breakdown structures/ resource plans � Scheduling, metrics and control� Cost estimates and budget � Contractor deliverables and scope management � Project/technical risk management � Procurement management and support� Administration of document workflows

ENGINEERING

Linking design to operational needs is key to project suc-cess. alliancebio’s engineers are specialized Owner’s Reps that work with the engineering design firm to deliver process and utility systems aligned with your needs. Alongside client teams, we provide generation and technical review of:

� Facility master plans, floor plans, P&IDs, 2D & 3D models� Bill of materials, instrument and component submittals� Flow path diagrams and sequence of operations� Operational readiness (SOPs, Training, Spare parts)

PROCUREMENT

Effective procurement keeps projects on track and ensures your requirements are attained—all at the right price. alliancebio’s team ensures that you confidently select the vendors and contractors best suited for your project. End-to-end procurement services include generation and technical review of:

� Client URS and P&IDs for bid package creation� Turnover package requirements� “Issued For Construction” specifications and drawings� Bid package/RFP assembly, bid evaluations, RFI� “Recommendation to Award” letters

CONSTRUCTION MANAGEMENT (OWNER’S REP)

Client interests can get lost in fast-paced construction environments. alliancebio’s Owner’s Representatives interface with construction firms to ensure completion— on time, within budget, and to owner’s specifications. We work directly with Construction Managers (CM) to:� Ensure scope is clear and all trades are qualified� Develop master construction schedules� Ensure CM is managing to project budget� Focus on safety—CM trains on and understands all client

procedures� Oversee site construction� Support installation verification and mechanical completion

STARTUP & COMMISSIONING

Startup and commissioning is a core strength at alliancebio. Our project managers and engineers have led numerous startups for new and retrofit facilities. We manage every aspect of startup and commissioning, including oversight and development of:� Requirements matrix and plan for commissioning

and validation� Startup and commissioning resource plan� System/equipment startup and commissioning protocols� Loop checks, installation and operational verification� Turnover packages submittals

FACILITIES OPERATIONS

Sustained operational success goes hand in hand with the ability to effectively maintain the building and equipment. alliancebio is the key partner to your Facilities Operations team and ensures long-term interests are protected after startup by developing:

� Complete Bill of Materials /component list with manufacturer, model, and part numbers

� Critical and noncritical systems and components lists � PM task schedules (per campaign, monthly, yearly, etc.)� PM SOPs and task lists� Spare parts and creation of spare parts kits for equipment� Training for Facility staff and management

Aligning operational success to tangible process knowledge.

The lifecycle of a product mimics the biology that underlies it—dynamic and highly complex. Whether just getting started or already at market, the peak performance of your operations is rooted in great process understanding and vision.


The commercialization of an effective and economically viable medicine is anything but simple. Unique challenges

and risk factors are combined with the pressure to shorten timelines, support start-up, maintain cGMP compliance,

and ensure great manufacturing performance.

The alliancebio BioProcess Services Platform was built in response to these pervasive challenges. The process and

operations expertise of the BSP team allow our clients to have:

• Access to high-horsepower subject matter expertise as a mechanism to hedge against strategic and tactical risks

• Our team as a highly accessible and integral part of your manufacturing performance management solution

• Use of a fully-customizable technology toolkit

BIOPROCESS SERVICES PLATFORM (BSP)

PROJECT INITIATION

PROCESS ELUCIDATION/ REFINEMENT

BASIS OF DESIGN/

DETAILED DESIGN

PROJECT SUPPORT

BIOPHARM OPERATIONS

UNIT OPERATIONS

EXPERTISE

PROJECT INITIATIONPROJECT SPAN: INITIATION

Management of stakeholder expectations is critical to any project’s success. The true cost of ownership and operation, often overlooked, provides decision-makers the full-picture justification for capital expenditure and long-term decision making. alliancebio leverages decades of construction and operations experience to develop reliable analyses, models and estimates, including:

� Business Justification: Executive-Level� Feasibility and Concept Studies� Site Capacity Planning System use and maintenance

PROCESS ELUCIDATION/ REFINEMENTPROJECT SPAN: R&DàCOMMERCIAL

Whether for new construction or existing operations, the quality of any chosen solution or design is dictated by the foundation of process understanding, requirements and specifications. alliancebio can develop and review key process/operations defining deliverables for all biopharm processes, including:

� Process Flow Diagramming� Process Simulation� Project Requirements and Specification Development

BASIS OF DESIGN/ DETAILED DESIGNPROJECT SPAN: FEASIBILITYàDETAILED DESIGN

Effective design review ensures the guesswork is gone from facility design and layouts to ensure user requirements are met and compliance with cGMPs can be achieved. alliancebio provides detailed design reviews at any stage of the project and can represent those reviews to owner teams or 3rd party design/construction firms.

PROJECT SUPPORTPROJECT SPAN: FULL LIFECYCLE

Effective staffing of projects is challenging. alliancebio project support personnel will support your teams with a focus on details and quality to ensure project success.

� Project Management� FAT/SAT/IOQ Execution and Support� BioProcess Vendor Qualification and Award� Task-force Team Management� Analytical/Tech Transfer� Facility Shutdown/Changeover Planning and Execution

BIOPHARM OPERATIONSSTAGE: R&D àCOMMERCIAL

With biomanufacturing operational expertise spanning R&D to large-scale production, the alliancebio team knows the technology, trends and regulatory environment to analyze and significantly improve operational capabilities, throughput & process control, while optimizing cost and minimizing risk.

� Master Hiring Plan� SOP/BR Generation and Review� Staff Augmentation� PAI Readiness� Operations & Equipment Training� Risk Assessments and CAPA Development� Continue Improvement: Facility Upgrades, Redesign� Facility Utilization: Insourcing� Facility Utilization: Outsourcing Due Diligence� CMO Management Support and Tools

UNIT OPERATIONS EXPERTISEPROJECT SPAN: R&DàCOMMERCIAL

SCALE (L): 50—25,000MODE: Batch, Fed-Batch, PerfusionHOST: Mammalian, Yeast, Insect, BacterialMOLECULE: mAB, Cytokine, EnzymeUPSTREAM: Inoculum, Seed Expansion, ProductionHARVEST: Centrifugation, FiltrationPURIFICATION: Chromatography, UF/DFFDP: Fill-Finish, LyophilizationMEDIA PREPARATION: Filtration, PasteurizationBUFFER PREPARATION: FiltrationSANITIZATION: CIP, SIP, VHP, Chlorine DioxideSAFETY: BSL1, 2, 2+, 3PROJECT MANAGEMENT: See OPM/Summary BrochuresAUTOMATION: See Automation Brochure


The team at alliancebio provides Process Control and AutomationServices to clinical and commercial clients in the life science industry. We provide the expertise needed for our clients to execute successful projects, and help them meet the demanding requirements facing the industry. alliancebio specializes in project management, control system design and integration, validation and support.


PROJECT MGMT.

SYSTEM INTEGRA-

TION

SUBJECT MATTER

EXPERTISE

ALARM AND DATA

MGMT.

REGULATORY COMPLIANCE

TECHNOLOGY ASSESS-MENTS

DISASTER RECOVERY

alliancebio has the experience needed to ensure our clients complete their projects on time and on budget.

From stand-alone PLC systems to facility wide DCS or building management systems, we have the resources needed

to deliver results. There are many automation providers that can deliver a good product. What makes alliancebio

unique is that we have the operational experience to understand how that product will be used and supported

throughout its entire life cycle.

PROCESS CONTROL & AUTOMATION SERVICES

PROJECT MANAGEMENT

The team at alliancebio can deliver project management and automation services to clinical and commercial biotech clients including:� Automation design review� Development/Review of system

life-cycle documents� System architecture development� Commissioning and validation support� Integration services for building

management, DCS and PLC systems� Startup of systems, equipment and facilities� Operator and technician training of control

system use and maintenance

SYSTEM INTEGRATION

We provide qualified automation resources for staff augmentation and project work, specializing in the following systems:� Allen-Bradley PLC, SLC and Logix Systems� RSView, FactoryTalk and PanelView HMIs� Emerson DeltaV and Provox� Wonderware InTouch, System Platform

and Historian� GE iFix, iHistorian and Unicorn� Siemens APOGEE and Insight� OSI PI


TECHNOLOGY ASSESSMENTS

Have questions about implementing wireless networks and instrumentation, single use technologies, Industrial Internet of Things (IIoT), virtual computing environments, OEE or electronic batch records? Let alliancebio assist with those assessments and generation of a cost/benefit analysis or ROI justification.

DISASTER RECOVERY

alliancebio can assist with Disaster Recovery evaluations and the generation of recovery plans and procedures to ensure the reduction of unplanned downtime.

SUBJECT MATTER EXPERTISE

We provide subject matter expertise in process control, instrumentation, PLC and distributed control system platforms, and automation of upstream and downstream bio-pharmaceutical operations.

ALARM AND DATA MANAGEMENT

We assist clients with design, planning, implementation and validation of alarm and data management systems, including process data collection, trending, reporting and analysis. We can also assist with an alarm review to ensure that nuisance alarms are minimized and operators only see what’s necessary.

REGULATORY COMPLIANCE

The alliancebio team has significant experience supporting GMP facilities, and can perform gap assessments and risk analyses to ensure clients maintain compliance with GxP and FDA regulations including adherence to 21 CFR Part 11. We provide security evaluations to ensure that clients’ automation systems and networks are protected, and assist with mitigation of risks identified.

owner’s project management (opm)...

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