Separation
Density-gradient centrifuges
Validated two-spin protocols for PRP and density-gradient separation for bone-marrow concentrate. Rotor speeds and timing logged per preparation.
Step · separation & concentrationInside Boulder Biologics
A clinic and an on-site biologics lab in one suite.
Our clinic is on the Boulder Community Health Foothills Campus. The lab and the procedure room share one suite, so samples for same-day treatments never leave it.
Location
4745 Arapahoe Ave, Suite 300
Boulder, CO 80303 · BCH Foothills
Patient rooms
3 exam rooms
Consultation · prep · recovery
Procedure room
Cleanroom-standard
Sterile prep · image-guided procedures
Biologics lab
Cleanroom-standard
Re-qualified on a schedule
Sample handling
Never leaves the suite
Closed-system · single-use kits
Procedure room
Where harvests and image-guided delivery happen.
A dedicated procedure room with sterile prep, point-of-care ultrasound, C-arm fluoroscopy, and the working space for both marrow aspiration and image-guided concentrate delivery. The room has HEPA-filtered air, one-way airflow, and continuous environmental monitoring.
- Sterile field for marrow aspiration and image-guided injection
- Point-of-care ultrasound for real-time soft-tissue, joint, and PSIS visualization
- Local anesthesia only; patients remain awake throughout
- Co-located with the biologics lab so concentrate returns within the same visit
Image guidance: musculoskeletal ultrasound · fluoroscopic guidance when indicated · sterile drape & instrument prep · closed-system collection at harvest.
The biologics lab
On-site processing, end to end.
A biologics laboratory inside the clinic. Density-gradient separation, characterization, and sterility checks happen in the same suite as the procedure, so the sample is processed and returned within a single visit in a space with a highly controlled & monitored environment.
Every preparation (PRP, bone marrow concentrate, and other biologics) follows the same standardized workflow. The lab is purpose-built for autologous, minimally manipulated biologics: short residence time, closed-system kits, and characterization that runs alongside the procedure.
What the lab prepares: two-spin PRP and density-gradient bone marrow concentrate.
Equipment
What's in the lab.
Hover over or tap a card to see the equipment.
Containment
Class II biosafety cabinet
HEPA-filtered laminar-flow workspace for sterile processing. Closed-system kits keep samples out of open lab air, and the biosafety cabinet is the backup.
Step · sterile transfer
Characterization
Flow cytometry
Flow cytometry sorts and counts the cells in a sample by the markers on their surface. We use it to check that our bone marrow process yields cells with the markers associated with MSCs (CD73, CD90, and CD105).
Step · QC validation
Environmental
Environmental monitoring
Particle counts, temperature, humidity, and surface-contamination checks logged on the lab floor, confirming the room is operating to the cleanroom standard it was qualified to.
Step · facility validation
Procedure
Fluoroscopy (when indicated)
Real-time fluoroscopic guidance available for joint, subchondral, and spinal procedures where ultrasound alone is insufficient.
Step · selected procedures
Cold chain
Specimen handling & cold-chain
Calibrated temperature-controlled storage for reagents and adjuncts, with same-visit delivery removing the need for long-term sample storage of patient material.
Step · supporting infrastructureCleanroom-standard facility
Sterility & Safety are #1
Our laboratory and procedure spaces are built and audited to cleanroom standards.
Particle counters and environmental monitoring run constantly throughout our clinical space, but they're just one way we confirm those rooms are operating at our standards. We also re-validate the space to ensure our cleaning protocols are working to prevent any contamination.
Build standardISO-8 Cleanroom
Re-qualificationRoutine, documented
MonitoringConstantly monitored, logged, and audited
Quality-control pipeline
We test what we deliver.
Every preparation passes a defined quality-control workflow before it ever reaches a patient. Every component, every step, and every person involved is tracked to a batch record in our Quality Management System.
Flow cytometry validates our process.
Our MSC preparation protocol is validated by flow cytometry, confirming the expected stromal-cell surface markers, cell content, and viability profile that our process consistently produces.
CD73+ / CD90+ / CD105+ confirmation
CD34− / CD45− exclusion
ISCT minimal criteria framework
Closed-system, single-use processing.
Your tissue stays in a sealed, single-use processing kit from harvest to delivery. Each kit is used for one patient, in one visit, and then thrown away.
Closed-system kit harvest → delivery
Single-use, single-patient
No open transfers
Every component, every step, traceable.
Every component that touches your preparation (syringes, reagents, processing-kit lots, instrument runs, cold-storage temperatures) is logged to a per-preparation batch record in our Quality Management System. The staff member and timestamp for each process step travels with it.
Per-preparation batch record
Component & lot traceability to the syringe
Personnel + timestamp per step
Sample chain of custody
Your sample never leaves the suite.
Same-day, same-visit means everything happens on one floor inside one suite. Below: the actual physical path of your tissue from harvest to delivery.
From draw to delivery, one floor, one visit.
No external shipping. No third-party processing center. No overnight storage of patient material.
- Step 01 Procedure room Harvest. Bone marrow aspiration under image guidance, or a standard blood draw. Collected into the closed-system kit at the bedside.
- Step 02 Hand-off · corridor Transfer. Same kit, sealed. Walked directly to the on-site lab by the clinical team. No courier, no transit, no break in custody.
- Step 03 Biologics lab Processing. Density-gradient centrifugation in the same closed-system kit. Biosafety cabinet is the sterile backup for transfers; the kit is primary.
- Step 04 Hand-off · corridor Return. Concentrate moves back to the procedure room, sealed, single-use kit, same staff.
- Step 05 Procedure room Delivery. Image-guided placement to the target tissue. Same room, same staff, same visit, no second appointment.
Standards we work to
The frameworks behind the workflow.
We don't invent quality standards in-house. The workflow above is built on published, externally-defined frameworks, the ones used in regulated biologics environments.
USP <71>
Sterility testing
U.S. Pharmacopeia chapter on sterility testing of biologic products. Our microbial-culture pipeline runs to its framework.
ISCT 2006
MSC minimal criteria
International Society for Cellular Therapy position paper defining MSC by surface markers (CD73/CD90/CD105+; CD34/CD45/CD14/CD19/HLA-DR−).
21 CFR 1271
HCT/P framework
FDA regulations covering human cells, tissues, and cellular and tissue-based products. Our bone marrow and blood treatments are autologous, minimally manipulated, and returned to you in the same procedure.
FDA guidance
Regenerative medicine
FDA guidance on regenerative medicine therapies and on HCT/Ps. It shapes how we describe our treatments and what we say about outcomes.
ISO 13485
Quality Management Systems
ISO standard for quality-management systems specific to medical devices and biologics. Our QMS implements its requirements, document control, batch records, traceability, and personnel-step logging, as the backbone of our preparation workflow.
ISO 14644
Cleanrooms & controlled environments
ISO standard for cleanrooms and associated controlled environments. Our laboratory and procedure spaces are built and qualified against its framework, with particle, temperature, humidity, and surface-contamination monitoring on-floor.
For the terms we use and how FDA rules apply to our procedures, see our FDA Guidelines page.
Visit us
Where to find us.
Boulder Biologics is on the Boulder Community Health Foothills Campus, just off Arapahoe Avenue. Free parking is available in the on-site lot and garage.
Boulder Biologics
4745 Arapahoe Ave, Suite 300
Boulder, CO 80303
- Campus
- BCH Foothills Campus
- Phone
- 720-550-6175
- Parking
- Free lot and garage parking on site
Schedule a call
Talk through whether biologics might help.
Tell us briefly what's going on. A member of our team follows up within one business day to schedule an appointment with Dr. Glowney or Ryan Shiling, MSN, AGNP-C.
720-550-6175