Genesis AEC Lab Planning Services

Lab Planning & Programming

Lab projects are complex. With a myriad of stakeholders involved—lab users and managers, company leaders, facility managers, health and safety experts, among others— planning can be challenging. While each stakeholder may understand a lab’s purpose from their unique vantage point, they often miss the full purview needed to foster innovation and accelerate growth.

Lab planners and programmers have that purview. They guide stakeholders to the best decisions for everyone’s needs. Brought on early in the design phase, their expertise can translate to significant cost savings, while reducing the need for value engineering efforts by right sizing your space and utility requirements at the project’s onset.

Our lab planning team of registered architects intuitively predict and proactively circumvent potential lab design challenges because they understand the nuances of research goals and scientific pursuits. As a result, we’re able to deliver effective workflows and efficient workspaces that increase productivity and boost employee morale.

Preemptive planning requires considering and evaluating every variable. For example, knowing that your team will spend countless hours on high pressure, mission-critical work, our lab planners can infuse elements such as natural light, outdoor views, indoor air quality, and ergonomics into designs that take employee health and wellbeing into consideration.

Just like the therapies you’re bringing to market, change is inevitable. New equipment, technologies, and processes may evolve before your lab design is complete. We address that at the forefront and build in adaptability. Partnering with our asset management team, we can share best practices for modular workstations; mobile casework; open, collaborative configurations; and automation. And if reducing your carbon footprint is a goal, we can help you with water conservation and energy efficiency. Perhaps, most importantly, we can do it all with virtual and augmented reality so you can envision the laboratory we’ll create together and make modifications before your lab is built.

Asset Management

Process and lab equipment are the backbone of the life science industry. However, that critical functionality comes at a cost. It’s a significant capital expenditure, accounting for 40% of a typical CapEx budget.

Protecting and optimizing that investment while ensuring your facility runs at peak efficiency is key.

At Genesis, that’s what we do. Our end-to-end asset management services can cover you from concept to turnover.

We provide certainty to avoid project pitfalls, delays, and scope creep; consistency to sidestep risks, costly errors, and downtime; and a single point of contact to ensure reliability, accountability, and oversight.

Our turnkey approach starts with pinpointing your needs from initial lab floorspace optimization to lifecycle planning. As your design moves to construction, we coordinate your procurement, installation, qualification, and validation efforts to ensure a science-ready space is available day one.

With expertise solely based in the pharmaceutical, biopharma, diagnostics and medical device industry, we serve as a member of your team. We lead the process with you, proactively connecting the dots so you don’t have to. We capture, track, monitor, and communicate all your asset management needs to each of the project stakeholders –lab users, management, facilities, quality, IT, automation, among others. That way, there are no surprises in the design and construction phases or management maintenance going forward. With our one stop approach, you benefit with improved operational efficiencies, expedited equipment turnover and science startup, and controlled costs.

OUR SERVICES

• Capital Project Asset Management

• Comprehensive Equipment Surveys

• Equipment Recommendation and Vendor Comparison

• Master Equipment List Development and Management

• Lab Reorganization Execution

• Schedule Development & Management

• Installation Planning & Execution

• Subcontractor and Vendor Management

• IT/Automation Coordination

• Document Control and Turnover Package

• Equipment Qualification and Validation

• Asset Onboarding Management

• Equipment Storage Coordination and Tracking

• Delivery, Uncrating, and Utility Hookup Management

• Budgeting and Estimating

• Procurement, Planning, and Execution

• Quote Development, Review, and Submission

“Genesis’ Asset Management team provided critical insight, guidance, and direction during the execution of our capital project. They managed our evolving equipment needs, handled vendor communication seamlessly, and ensured we stayed within budget. Once equipment was on site, they coordinated the installation and construction activities so turnover of the space meant ‘ready for science.’ As follow-through, they tracked asset onboarding into our CMMS system to close the loop; an often-overlooked aspect of turnover.”

-Director, Preclinical Strategic Operations Global Healthcare Company

WHAT SETS GENESIS AEC APART

Our mantra is simple. Lead with vision. Deliver value.

Unlike other firms, we challenge the status quo. We view things differently. And we think differently.

If you’ve ever played chess, you know that success lies not in planning your next move, but in being able to envision the whole board. It’s the same at Genesis. Leading with vision, we anticipate, understand, and address what lies ahead in both your current project and your future needs– seeing and solving the challenges others often miss to give you a distinct, competitive advantage.

Our goal is to provide you with a long-term advantage. It doesn’t matter if you’re an emerging startup with a minor facility renovation or if you’re a multinational biotech company with complex, multi-site EPCMV projects, we listen to your needs and strategize the best possible outcome. We view your project from every angle, unlocking opportunities and uncovering any challenges to provide the solution that’s right for you.

But we don’t just see and think differently. We work differently, too. Other firms have SMEs. We have visionaries. Our leaders are experts in systems, people, and processes who have helped ‘write the book’ (e.g., ISPE guidelines, ISO regulations, BPOG guidance, etc.) and have trained the global industry in design, compliance, and operations. Sought after for their ability to navigate the life sciences landscape, they lead with a rare combination of logic, intellect, and imagination.

We invite you to envision the possibilities. Working together, we can help you build a better tomorrow for patients everywhere.

ABOUT GENESIS AEC

Since 1997, Genesis AEC has helped life sciences companies usher in the next generation of life-saving therapies, treatments, and technologies with its award-winning consulting, architecture, engineering, construction management, CQV, and asset management services. Whether it’s providing AE support for existing sites; commissioning, validation, and qualification for specific processes or equipment; or turnkey design-build solutions, our team blends sound science and technical expertise with quality and safety to deliver unparalleled results.

Lab Manager Article

Pinpointing Equipment Needs is Foundational to Laboratory Design and Construction

EQUIPMENT COORDINATORS BRIDGE THE GAP BETWEEN PEOPLE, PROCESSES, AND EQUIPMENT TO CREATE SAFE AND EFFICIENT LABORATORY SPACES

Pinpointing Equipment Needs is Foundational to Laboratory Design and Construction

Apr 20, 2022Genesis AEC

EQUIPMENT COORDINATORS BRIDGE THE GAP BETWEEN PEOPLE, PROCESSES, AND EQUIPMENT TO CREATE SAFE AND EFFICIENT LABORATORY SPACES

Apr 20, 2022Genesis AEC

Greg Lundell is the director of equipment services at Genesis AEC. His background is in research, development, operations, and quality management for a variety of diagnostic, industrial, and biological product research and manufacturing organizations.

Greg Lundell is the director of equipment services at Genesis AEC. His background is in research,development, operations, and quality management for a variety of diagnostic, industrial, and biological product research and manufacturing organizations. Stephanie DeLuca, AIA, is the director of lab planning at Genesis AEC. She has experience working on laboratory projects ranging from one-room renovations to multibuilding strategic moves involving multiple science groups in new and renovated facilities.

Greg Lundell is the director of equipment services at Genesis AEC. His background is in research, development, operations, and quality management for a variety of diagnostic, industrial, and biological product research and manufacturing organizations.

Q: How can laboratory equipment influence the design and construction of a space?

Stephanie DeLuca, AIA, is the director of lab planning at Genesis AEC. She has experience working on laboratory projects ranging from one-room renovations to multibuilding strategic moves involving multiple science groups in new and renovated facilities.

SD: Designing a successful lab means appreciating and understanding the connections between people, processes, and equipment. Strategic planning for lab equipment is

Stephanie DeLuca, AIA, is the director of lab planning at Genesis AEC. She has experience working on laboratory projects ranging from one-room renovations to multibuilding strategic moves involving multiple science groups in new and renovated facilities.

Greg Lundell

PHOTO PROVIDED BY GENESIS

instrumental to a lab’s layout, as it paves the way for space planning, casework, and required utilities. This planning guides critical design decisions such as whether to pursue a lab that’s fit-for-purpose or one with more embedded flexibility. Ultimately, equipment influences the type of space required and helps establish the appropriate design approach.

Q: How can laboratory equipment influence the design and construction of a space?

GL: Identifying equipment-specific considerations early in the design process ensures that both equipment requirements and lab user needs are met. For example, analytical equipment needs solvent storage, disposal, gasses, and electrical connections; and hazardous materials may require a fume hood or biosafety cabinet.

SD: Designing a successful lab means appreciating and understanding the connections between people, processes, and equipment. Strategic planning for lab equipment is instrumental to a lab’s layout, as it paves the way for space planning, casework, and

Q: How can laboratory equipment influence the design and construction of a space?

SD: Designing a successful lab means appreciating and understanding the connections between people, processes, and equipment. Strategic planning for lab equipment is instrumental to a lab’s layout, as it paves the way for space planning, casework, and

Greg Lundell

PHOTO PROVIDED BY GENESIS

required utilities. This planning guides critical design decisions such as whether to pursue a lab that’s fitfor-purpose or one with more embedded flexibility. Ultimately, equipment influences the type of space required and helps establish the appropriate design approach.

Q: What are some common challenges that arise during a lab project, and how can they be avoided or addressed?

SD: All lab projects have an inherent level of complexity. With a myriad of stakeholders involved—lab users, scientific leaders, lab managers, company leaders, facility managers, health and safety experts, among others—this complexity is not surprising. While each stakeholder may understand the labequipment’s purpose from their unique vantage point, they rarely have the full purview needed for a holistically designed space.

GL: Identifying equipment-specific considerations early in the design process ensures that both equipment requirements and lab user needs are met. For example, analytical equipment needs solvent storage, disposal, gasses, and electrical connections; and hazardous materials may require a fume hood or biosafety cabinet.

GL: Leaving the equipment list to multiple stakeholders–who have other job priorities–can be costly and time-consuming due to gaps in information and a lack of oversight. Appointing a single “owner” of a comprehensive equipment list that accounts for each stakeholder’s priorities helps align the team and entire project. This enables central tracking and communication of equipment dimensions, required utilities, IT or software needs, and even the budget.

Q: What are some common challenges that arise during a lab project, and how can they be avoided or addressed?

Q: What is the role of the equipment coordinator, and how can laboratories benefit from their expertise and service?

SD: All lab projects have an inherent level of complexity. With a myriad of stakeholders involved—lab users, scientific leaders, lab managers, company leaders, facility managers, health and safety experts, among others—this complexity is not surprising. While each stakeholder may understand the lab equipment’s purpose from their unique vantage point, they rarely have the full purview needed for a holistically designed space.

GL: Often during design, each engineering discipline reviews equipment information from a vendor for their specific needs, creating siloed information. In our model, the equipment coordinator serves as a single point of contact to the entire project team across the entire project lifecycle. They field equipment questions in a timely manner; survey existing equipment; develop a list of potential new equipment; and communicate with the lab users, their management, and the design team. This integrated approach improves efficiency. It also yields a net reduction in design fees and churn, and has fewer impacts on cost, timeline, or redesign.

Q: What is the role of the equipment coordinator, and how can laboratories benefit from their expertise and service?

GL: Often during design, each engineering discipline reviews equipment information from a vendor for their specific needs, creating siloed information. In our model, the equipment coordinator serves as a single point of contact to the entire project team across the entire project lifecycle. They field equipment questions in a timely manner; survey existing equipment; develop a list of potential new equipment; and communicate with the lab users, their management, and the design team. This integrated approach improves efficiency. It also yields a net reduction in design fees and churn, and has fewer impacts on cost, timeline, or redesign.

GL: Leaving the equipment list to multiple stakeholders–who have other job priorities–can be costly and time-consuming due to gaps in information and a lack of oversight. Appointing a single “owner” of a comprehensive equipment list that accounts for each stakeholder’s priorities helps align the team and entire project. This enables central tracking and communication of equipment dimensions, required utilities, IT or software needs, and even the budget.

SD: Simply stated, having an equipment coordinator focused on user equipment needs and requirements at the forefront of the design process can enhance and improve a lab’s design coordination, productivity, innovation, and performance.

SD: Simply stated, having an equipment coordinator focused on user equipment needs and requirements at the forefront of the design process can enhance and improve a lab’s design coordination, productivity, innovation, and performance.

“Designing a successful lab means appreciating and understanding the connections between people, processes, and equipment. ”

Stephanie DeLuca, AIA PHOTO PROVIDED BY GENESIS

“Designing a successful lab means appreciating and understanding the connections between people, processes, and equipment.”

Resumes

MICHAEL MARONE, AIA VP OF ARCHITECTURE

REPRESENTATIVE EXPERIENCE

ATHENEX, DUNKIRK, NY

Pharmaceutical Manufacturing Facility

BRISTOL MYERS SQUIBB, NEW BRUNSWICK, NJ

B48 Lab and Office Renovations

BRISTOL MYERS SQUIBB, CAMBRIDGE, MA

R+D Discovery Facility

CATALENT , WINCHESTER, KY

P hase IV Orals

CATALENT , BALTIMORE, MD

Gene Therapy Production Facility

GSK, CONSHOHOCKEN, PA

cGMP Nucala Warehouse

SPARK THERAPEUTICS, PHILA DELPHIA, PA

Clinical Manufacturing Headquarters

WUXI APP TEC , PHILADELPHIA, PA

Cell Therapy Facility

EDUCATION

TEMPLE UNIVERSITY

Bachelor of Architecture

REGISTRATION

LICENSED ARCHITECT

FL, IL, KY, MA, NC, NJ, OH, PA, RI, SC, TN , TX

BIO

Michael Marone brings to Genesis more than 20 years of professional experience. In his position of Vice President of Architecture, Mike is responsible for the delivery of all architectural services at Genesis as it relates to quality of deliverables, technical development of staff, and financial performance of the architectural division. His responsibilities include client and project executive management, project execution and staff development for all architectural disciplines including Architectural Design, Laboratory Planning, Process Architecture, Architectural Technology, and Interior Design. Mike has a vast array of life science, workplace, corporate HQ, university, and building envelope experience as a design professional.

As a strong conceptual planner and designer, Mike has broad experience in programming and managing major life science projects from R&D through Manufacturing and through all phases of design and construction. This indepth participation provides the experience of testing new concepts and ideas through design development, constructability reviews, “value engineering” challenges and other hurdles of a contemporary building project. Mike’s approach has always been responsive to the client and his design is not forced but successfully appropriate for the context of the project

REPRESENTATIVE EXPERIENCE

ADM , Erlanger, KY Lab and Office Renovation and Expansion

PTC THERAPEUTICS , Bridgewater, NJ Lab and Office Relocation Concept

BAUSCH+LOMB, R ochester , NY New Contact Lens Manufacturing Facility

BMS, New Brunswick , NJ

B48 Lab and Office Renovations

BMS, C ambridge , MA

R+D Facility

BMS, Devon , MA

Biologics Development Fit - Out Peer Review

MERCK, West Point, PA WP46 Vaccine Laboratory Expansion

MERCK, West Point, PA

MPI Master Planning Implementation

MERCK, West Point, PA

B16 Realization Project

STEPHANIE S. DELUCA, AIA DIRECTOR

PLANNING

OF LAB

EDUCATION

TEMPLE UNIVERSITY

Bachelor of Architecture REGISTRA TION REGIS TERED ARCHITECT

BIO

Stephanie DeLuca offers more than 16 years of professional experience in the architectural community, specializing in science and technology projects, with a focus on existing facility renovations. She is an experienced lab planner and project manager, developing strong relationships with clients and has a reputation for leaving no detail unturned.

Stephanie possesses a strong technical skillset with an innate ability to align user requirements with current industry benchmarks and metrics. Her approach to projects results in a facility that is right-sized and fit-forpurpose.

In her current role, Stephanie leads major projects and initiatives while overseeing a team of lab planners, encouraging mentorship at all experience levels and helping teams develop a mindset that creativity and innovation are the key to successful project challenges and integrated solutions

In addition to active architectural practice, Stephanie is a recurring volunteer for the PALM (Promoting Advocacy through Licensure + Mentorship) Program, whose purpose it is to create a dialogue between architects to share career experiences and goals. She also serves as a guest juror at local universities including Temple University and Drexel University, and has served as an adjunct faculty member of the Temple University Architecture Department.

REPRESENTATIVE EXPERIENCE

BMS, CAMBRIDGE, MA R+D Discovery Facility

MERCK , WEST POINT, PA

cGMP Sterile Supply

MINARIS , ALLENDALE, NJ

cGMP Facility Expansion

MERCK , NORTH WALES, PA Manufacturing Research Laborator ies

MERCK , WEST POINT, PA NMR Laboratory

MERCK, WEST POINT, PA Imaging Suites

BMS , MANATI, PR Laboratory & Office Planning

MERCK , NORTH WALES, PA cGMP Cell Bank Facility

CLIENT, GRANTS PASS, OR Nutritional Production Laboratory EDUCATION

UNIVERSITY OF PENNSYLVANIA

Master in Environmental Building Design

CORNELL UNIVERSITY

Bachelor of Architecture

KELLY SMYTH, AIA Project

Architect

BIO

Kelly Smyth offers 12 years of professional experience in architectural practice, with specialization in lab planning and design. Her experience includes cGMP manufacturing facility design and environmental building design and research. Kelly has diverse project experience including higher education, laboratory, healthcare, residential singlefamily and multi-family, commercial/retail and public space design. Her focus in science and technology projects and laboratory design spans much of her professional career and continues to be her specialization at Genesis.

Kelly has honed her technical skillset and planning abilities to provide excellent design and client-centered service. She is experienced in the implementation of BIM (building information modeling) software for building design and renovation.

With a strong interest in energy efficiency and sustainable building practices, Kelly previously researched current building renovation practices and contributed to the publication of a commercial building retrofit roadmap as a University of Pennsylvania research assistant with the Energy Efficient Building Hub.

REPRESENTATIVE EXPERIENCE

2SEVENTY BIO , CAMBRIDGE MA

cGMP , Lab & Office

B ROOKLYN IMMUNO

THERAPEUTICS , CAM BRIDGE MA

Lab & Office Fit - Out

CONFIDENTIAL, SOMERVILLE, MA

Lab & Office Fit - Out

KYMERA THERAPEUTICS, WATERTOWN, MA

Lab & Office Fit - Out

DECIBEL THERAPEUTICS, BOSTON, MA

Lab & Office Fit - Out

CONFIDENTIAL, CAMBRIDGE, MA

Core and Shell Renovation

SHIRE, LEXINGTON, MA 95 Haden Expansion

UNIV. OF MASS. WORCESTER, MA

Medical School , Lab & Office

GENZYME, FRAMINGHAM, MA

Biologics Support Center

EDUCATION

UNIVERSITY OF OKLAHOMA

Bachelor of Architecture

PRIYANKA MASHELKAR

Assoc AIA.

LEEP AP BD+C

Associate Director of Architectural Operations, New England

BIO

Priyanka Mashelkar offers more than 20 years of professional design experience in both architecture and interior projects with extensive experience in area of design, working drawings, BIM coordination, and managing projects. She has acted as the liaison with both the owner and contractor through all phases of construction.

Priyanka has successfully managed and delivered projects including research facilities, corporate commercial, and higher education. She has the proven ability to lead multidisciplinary design teams and share expertise with peers and junior staff while establishing strong and lasting client relationships.

Priyanka has completed projects for a variety of the following clients:

Brooklyn Immuno Therapeutics

Bristol-Myers Squibb Decibel Therapeutics

Fidelity Investments Genzyme

Harvard University Kymera Therapeutics

MBTA MITIMCo

Shire Pharmaceuticals University of Massachusetts

Whole Foods Market 2seventy bio

Takeda Pharmaceuticals Organogenesis

Sample QC Presentation

Objectives

Review capacities for unit operations and supporting functions

Evaluate operations and functions against targeted increase in samples

Identify any constraints in processes, personnel, equipment, time

Provide recommendations based on functional need and prioritization

Evaluate recommendations against facility master planning intentions support functions, and/or efforts external to QC team

Existing Operations Process People Space

Process*

Product X shown

• QC receives XX in-process samples

Samples processed by QC SM

Assumption: each line item is a bag coming to SM; each bag has some XXXX step/prep

QC-2 spaghetti diagrams: Samples: Assays 12,16,25,32

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XXXXX

QC-2 spaghetti diagrams: Samples: Assays 8,9,10,11

QC-1spaghetti diagrams: Samples: Assays 1,2,3,4

Time critical assays. Processing begins:

*Immediately

**Within XX min

***Within X hours

QC-2 spaghetti diagrams: Samples: Assays5,6,7

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Current shift operations

Overall –XXFTE’sin QC Lab Area

4 shifts

All shifts overlap for Xhours

All groups use same shift structure

Current shift operations

by Group

QC Lab Space Distribution

Totals

XXXX net square feet (SF)

XXX equivalent linear feet (ELF)

QC -1

• XXXX SF, xxx ELF

QC Sample Management

• XXXX SF, xxx ELF

QC -2

• XXXX SF, xxx ELF

Corridor & Support (e.g.Airlock)

• XXX SF

Out of QC Lab footprint

Metrics include all space utilized by group such as working bench space, benchtop equipment, refrigerator/freezer storage, etc.

QC Lab Samples, Processes and Assays

Information provided to Genesis

Base Process Assumptions

Current capacity: XXX-XXXsamples per week

Target capacity: XXXsamples per week (XX samples/day)

• Receipt of sample material is evenly distributed across week

• Current operations must not go down/offline

• Target areas will be identified for improvement

• Scale up of productis a corresponding scale up of samples received (exception: routine EM sampling)

Materials/Tools Used

• Selective process/capacity modeling, targeting evaluation of:

• Headcount

• Equipment

• Time

• Architectural laboratory and space planning

Process Summary by day and frequency of Assay

Available Space

Sample Management

Key areas of concern

Sample Pathways

XX minutes per bag

Samples are processed in XXX and follow one of three paths.

All samples are received and labeled.

Then,

Path 1: sample sent directly to lab

Path 2: sample is frozen and retained

Path 3: sample is pre-processed using centrifuge and then sent to lab

QC Sample Allocation

1. Sample Receipt & Initial Processing

• XX stations, staffed XX hours per day (Xam-Xpm) = XX hours

• XX product / 7 days = XXX samples per day processed

• XX product * X bags = XXX bags/day processed

• XX min/bag, XXX bags/X bags per hour = XX hours/day required to process (< XX hours)

Conclusion: Existing workstations (and FTE’s that occupy them) can accommodate sample increase

2. Sample Receipt & Processing to Long Term Freezer Storage

• XX samples are processed to cold storage

• XX products/day * XX samples = XXX samples/day to cold storage

• Two (2) BSCs available for adding cryofluids = XX hours/day. Each sample must require less than 3 minutes of BSC time.

• Frequency of travel to/from LN2 freezers does not increase with product increase

• -80 storage space for additional XX samples/day required

Conclusion: Increase in samples does not increase time to LN2 freezers; will increase -80 and LN2 freezer requirements

Conclusion: Sample prep in BSC might be a bottleneck (insufficient data to analyze)

3. Sample Receipt & Processing prior to MB and Analytical

Distribution

• XXproducts/day * X samples requiring processing = XX samples/day

• Each centrifuge run takes 30 min to process once at this step, if XX samples are processed in one run then the utilization is 10 minutes per sample (after initial processing). XX samples x 10 minutes = XX h.

Conclusion: Increase in products does not require additional equipment.

Assumptions

Processes –Key Areas of Concern

• Seats are occupied full-time for duration of shift

• Product start days are evenly distributed across working days

• Receipt of product samples is evenly distributed across working days and shifts

• Each process step’s samples are a single bag

• Time for accessioning all samples in a bag is 15 minutes regardless of how many vials (1 to 6) are in the bag

• Full duration of shift is utilized

Assumptions

• Each vial is individually processed in a BSC

• Processing time in BSC must be short to accommodate the sample load, but there is insufficient information (question)

• Open Item: capacity of existing freezers to support additional samples

• Open Item: cleaning required at BSC after processing each sample? Bag?

Assumptions

• Time indicated for this step assumed to be for a centrifuge run including preprocessing in BSC and each run can process up to six samples

• Samples in centrifuge can be from multiple products

• Cleaning time for BSC is included in 30 min duration

• Product start days are evenly distributed across working days

• Receipt of product samples is evenly distributed across working days and shifts

Initial Conclusions: QC Sample Management

Based on data received and observed, Sample Management space can accommodate XXX samples week desired capacity without changes to space.

Processes could work more efficiently if select updates are made to targeted areas on the floor plan. These are contingent on decisions made to improve capabilities of other QC groups.

QC SM –Recommendations

Improvements to further optimize operations, not address inability to meet target products

• First priority–if needed -locate all -80 storage needs in close proximity toLab XXXX (XXXX ideal)

• Free up space closer to working lab (in XXXX) will be dependent on decisions made for QC-1

• Use space created in XXXX by relocating -80C freezer to XXXX for additional sample processing station

• Creating bmbjbnjrnbnb, not recommended at this time

Key areas of concern

• Proximity of assay-specific equipment to one other

• Equipment reliability, capacity and proximity to work areas –and the impacts these factors have torequired FTEs and product targets

• Existing space is not available for immediate expansion/alleviation of current issues

QC-1

Example: Routine XX Sampling Assay, Scenario 1*

1.Pick up samples in XXXX.

2.Take sample to XXXX for processing.

3.Process in XXXX, move to XXXX for incubation.

4.Bring samples back to XXXX for read.

*Alternate scenarios:

1.Incubate in XXXXinstead. In this event, extra read is required adding 60 minutes to process.

2.Incubate in XXXX. Incubators are farther away than XXXX and must be brought back to XXXX for read just like above.

3.See process diagram for detailed descriptions of activities.

Personnel/Material

QC-1

XXXX Incubator Allocations –Pre-current

XXXX Incubators Darwin Chambers

Routine XX Sampling XX Samples

Limited capacity, challenges include:

1.When units are OOS.

2.Emptied for calibration.

3.Increase in volume due to added testing areas (e.g.media prep #2, hallways, other clean room projects, power outages, additional EM, etc.)

*Requires –qual can’t happen while XXX samples in chamber

XXXX Samples (Days X to XX)

XXXX 20-25C

Limited capacity: when all units operational, can accommodate a max of 48 samples at a time with no equip redundancy

XXXX Incs

Lot-related product XX samples

210 SF 30 ELF

XXXX Plates

Lot-related product samples*

XXXX Samples (Days X to XX)

XXXX Samples

Lot-related product XX Samples

Lot-related product samples*

XXXX 30-35C

Initial Conclusions: QC -1

Based on data received and observed, QC-1 space can accommodate XXX samples week desired capacity without changes to space.

Processes could work more efficiently if select updates are made to targeted areas on the floor plan. These are contingent on decisions made to improve capabilities of other QC groups.

QC-1

Optimizing Space

Addition of two XXXX, when all areworking, can accommodate XXX samples at a time PLUS XX units for PM/redundancy AND eliminate need for use of XXXX for Sample/Lot EM Assay and additional FTE time reading plates

Create new lab for 25C chambers; provide redundancy for backup in lieu of converting XXXX/XXXX temps; keeps all chambers in close proximity toLab XXXX Lab fits up to (6) chambers –current count is (5)

Removal of two workstations to make room for XXXXs; with addition of XXXX, workstations in this area might not be needed anyway due to increased automation

Relocated Gowning Gowning Supply

Shift workstations down to provide appropriate working aisles

The remote incubators in XXXX can be retained and serve as an emergency overflow.

QC -1 –Recommendations

Improvements to further optimize operations, not address inability to meet target sample counts

• First priority–troubleshoot equipment to streamline incubation and maximize efficiency; or utilize alternate method 100%

• Utilizing two processes makes solution based on need difficult to pinpoint

• Locate all XXXXXwith same setpoints/requirements in close proximity.

• Construct incubator storage area (less $/time)

• Construct storage room and airlock (more $/time, but also more capability).

Future Considerations

• QC-1: XXXX Function brought in house (contract out now)

• Space needed to support this function has not been identified; additional space or sharing of existing equipment –or both –likely

• QC-2: XXXX testing to shift to external facility

• Frees up Lab XXXX for alternate function(s)

• CTU (refrigerator, freezer, incubator) capacities not able to be confirmed sufficient with data provided.

Next Steps

• Confirm overall department goals

• Desire to achieve complete optimization?

• Desire to improve current processes with target (beyond sample count)?

• Is there a campus master plan? How is QC impacted by decisions/drivers outside of the immediate department?

• Time lapse modeling for precision information, confirmation of duration lengths for processes and steps, if desired

Summary and conclusions

(as of 6/3/2022)

• QC spaces were evaluated against general time and motion. Not all processes happen in a defined window of time, nor a consistent frequency.

• Select processes and equipment were evaluated in more detail using sample numbers and equipment capacity to confirm fit/increase.

• Some processes are unable to be evaluated definitively based on the data received. They appear they could operate with an increase in samples, but this is speculative only.

Appendix/Backup Data

Square Feet (SF) and Equivalent Linear Feet (ELF)

Square feet (SF) is a measurement of the area of a space.

Equivalent linear feet (ELF) is a measurement of the usable linear feet of a space.

~49 ELF ~49 ELF

~41 ELF

ELF is a better indicator of space required