We understand project execution under cGMP environments

Life Science is all we do. 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.

35 North has Expertise in Life Sciences
Our areas of expertise
35 North has Expertise in Life Sciences and Pharmaceutical Manufacturing Practices

PHARMACEUTICAL MANUFACTURING PROCESSES

We have expertise in pharmaceutical manufacturing processes. 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 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
35 North has Expertise in Life Sciences and Laboratories
35 North has Expertise in Life Sciences and GMP Manufacturing Packaging and Conveyor Systems

GMP MANUFACTURING, PACKAGING, & CONVEYOR SYSTEMS

We have extensive experience working in project building or impacting 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 wide experience in the design, construction and qualification of GMP warehouses, temperature controlled rooms, 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
35 North has Expertise in Life Sciences and GMP Warehouses and Temperature Controlled Rooms
35 North has Expertise in Life Sciences and Support Infrastructure for GMP Operations

SUPPORT INFRASTRUCTURE FOR GMP OPERATIONS

We understand the relevancy and importance of the infrastructure required to serve a GMP 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 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
35 North has Expertise in Life Sciences and General Offices Amenities and IT Infrastructure
Our certifications

We are proud to have earned these small, veteran-owned, and historically under-utilized designations. These certifications combined with our deep expertise makes us a preferred partner for many firms.

SDVOSB, Service-Disabled Veteran-Owned Small Business
Historically Underutilized Business Certification, North Carolina
SWaM Certification, Small Women-Owned and Minority-Owned Business, Virginia
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 services and expertise are second to none, and our success is driven by the decisions we make, the policies we implement, and how our employees are trained.

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get started?

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Get Started with 35 North

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