We understand project execution under cGMP environments
We specialize in life sciences construction project management, commissioning, and build cost estimating.
From offices, laboratories, manufacturing areas, and general infrastructure, we understand the challenges of running a project in FDA-regulated environments. Our learning curve in our clients’ facilities is minimized by our experience and expertise, allowing us to provide the most value.
Our areas of expertise
PHARMACEUTICAL MANUFACTURING PROCESSES
We have expertise in pharmaceutical manufacturing processes and the construction, commissioning, and operational readiness of facilities. We have managed projects for key pharmaceutical companies delivering:
- Clean and aseptic rooms
- Sterile solid dose preparation areas
- Powder feeding and continuous manufacturing
- Blending, milling, granulation, and formulation
- Fermentation, purification, and conjugation process
- Injectables sterile fill and packaging facilities
- Conveyors and clean packaging automation
- GMP warehousing, automated storage, and retrieval warehouse systems
LABORATORIES
Life sciences and biotechnology is the core of what we do, and we excel at it. We have completed life science labs for new and renovated facilities in the biotech, pharma, gene therapy, and healthcare industries. We have solid experience in the programming, design, construction, and commissioning of labs. Our experience includes:
- Research and Development Labs
- Product Development Labs
- BSL-1, BSL-2, and BSL-3 Laboratory experience
- Commercial Quality Control Labs
- Chemical and Biological Analytical Labs
- DNA Sequencing Labs
- Metrology Labs
GMP MANUFACTURING, PACKAGING, & CONVEYOR SYSTEMS
We have extensive experience in cGMP construction and commissioning, working in manufacturing areas for GMP operations such as:
- Upstream bioprocesses: inoculation, isolation, cell-culture media, fermentation
- Downstream bioprocess: centrifugation, filtration, cell disruption, purification
- Specific gene therapy experience including: apheresis, peripheral blood mononuclear cells isolation, preservation, and culture, antigen and marker labs, CAR T-cell transduction, expansion, purification, collection and infusion.
- Dedicated cleanroom facilities for cGMP production of noble products
- Finish and fill processes: conjugation, formulation, compounding, sterilization and sterile fill
- From bulk to single dose sterile fill lines, packaging, warehousing, shipping, and receiving operations
- Pressurized metered dose inhaler manufacturing
GMP WAREHOUSES & TEMPERATURE CONTROLLED ROOMS
35 North has a wide range of experience in the design, construction, and qualification of GMP warehouses, temperature-controlled rooms, and building automation systems.
- Managed the design, construction and qualification of multiple GMP warehouses
- Experience with projects including multiple environmental chambers of varying complexity and size
- Managed the design, installation and qualification of complex automation control systems
SUPPORT INFRASTRUCTURE FOR GMP OPERATIONS
As experts in cGMP commissioning and construction, we understand the relevance and importance of the infrastructure required to serve your facility.
- Redundant backup and emergency generation strategies, including backup generators, flywheel UPS, and traditional battery-operated UPS
- Waste accumulation areas required by code, OSHA / EPA compliance, and local regulation for the management of hazardous materials including bulk devitalization
- Tank farms and gas mixing systems for the distribution of liquid and gases, including CO2, O2, N2
- Cleaning and sterilization; including washers and autoclaves
- Clean in place (CIP) and sterile in place (SIP) systems
- Conveyor systems for optical coherence tomography (OCT) for bulk quality control
- Bulk vapor hydrogen peroxide chambers for bulk sterilization of packaging
- Computational biology infrastructure including automated labs connected by fiber optics to high performance on-site data centers
GENERAL OFFICES, AMENITIES, & IT INFRASTRUCTURE
Many of the construction projects we have managed include campus programming and strategies that address central support functions which include:
- Evaluating open workplace strategies for workflow and efficient operations
- Internal and external conferencing options / schemes
- AV, tele-conferencing, video conferencing
- Dining facilities and break areas
- Security and rapid response strategies for regulated areas
- Health centers and nursing stations
- Computational support including on-site data centers
Our certifications
We are proud to have earned these small, veteran-owned, and historically under-utilized designations. These certifications, combined with our deep expertise in cost estimating, construction project management, and enhanced commissioning, makes us a preferred partner for many firms.
SDVOSB
35 North is certified as a Service-Disabled Veteran-Owned Small Business with the Department of Veteran Affairs.
HUB Certified
We are registered as a HUB Certified Business with the State of North Carolina Department of Administration.
SWaM
35 North is a registered Small, Women and Minority Owned business with the Commonwealth of Virginia Department of Small Business and Supplier Diversity.
Let us put our expertise to work for you
We’re excited to partner with you! Our business consulting services and expertise in construction and project management are second to none. Our success is driven by the decisions we make, the policies we implement, and how our employees are trained.
What our clients are saying
“They’re exceptional in that their approach to their work is very comprehensive. They understand the nuances of complex organizations and projects.”
- PATRICK O’KEEFE
Principal
“They came highly recommended. I would definitely recommend them to others. They are my eyes and ears on the ground. 35 North fixes things before they become big, expensive and time-consuming problems.”
- MIKE MYERS
Senior Financial Planning & Analysis Director
“We have witnessed first-hand their knowledge, experience, integrity, and commitment to customer satisfaction.”
- NATHAN BLAZEI
Senior Manager, Process Operations
