Inside Boulder Biologics

A clinic and an on-site biologics lab in one suite.

Our clinic is at the Boulder Community Health Foothills Campus and is built for one purpose: same-day, same-visit autologous therapy where your sample never leaves the suite.

Image-guided procedure room On-site biologics lab Cleanroom-standard processing

Go straight to the lab

Location 4745 Arapahoe Ave, Suite 300 Boulder, CO 80303 · BCH Foothills

Patient rooms Exam rooms Consultation · prep · recovery

Procedure room Cleanroom-standard Sterile prep · image-guided procedures

Biologics lab Cleanroom-standard Built & audited by FDA-regulated partners

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. This room also features ISO-compliant HEPA filtration, one-way airflow, and robust environmental monitoring systems.

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 clinical preparation, PRP, bone-marrow concentrate, adjunct biologics, moves through a standardized workflow under our processing protocols. The lab is purpose-built for autologous, minimally-manipulated biologics: short residence time, closed-system kits, and characterization that runs alongside the procedure.

Featured throughput: two-spin PRP · density-gradient bone marrow concentrate · selected adipose work · MSC enumeration by flow cytometry where appropriate.

Equipment

What's in the lab.

Hover any card to see the equipment behind the role it plays in the workflow.

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 & concentration

Containment

Class II biosafety cabinet

HEPA-filtered laminar-flow workspace for sterile processing. Sample exposure to open lab air is avoided by design, biosafety cabinet is the backup, closed-system kits are primary.

Step · sterile transfer

Characterization

Flow cytometry

Surface-marker characterization of the MSC-containing fraction. CD73+ / CD90+ / CD105+ confirmation; CD34− / CD45− exclusion, by ISCT minimal criteria.

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 infrastructure

Cleanroom-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

Qualificationper FDA regulations

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.

QC · 01

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. Not assumed, measured.

CD73+ / CD90+ / CD105+ confirmation
CD34− / CD45− exclusion
ISCT minimal criteria framework

QC · 02

Closed-system, single-use processing.

Your tissue moves through a sealed, single-use processing kit from harvest to delivery, the sample never touches open lab air. One kit, one patient, one visit; the kit is discarded after.

Closed-system kit harvest → delivery
Single-use, single-patient
No open transfers

QC · 03

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 or venous draw under image guidance. 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. We operate inside the same-day, minimally-manipulated, autologous lane.

FDA guidance

Regenerative medicine

FDA marketing-and-claims guidance for regenerative medicine. Shapes our terminology, "mesenchymal stromal cells," not "stem cells", and our outcome framing.

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 full FDA-aligned terminology and regulatory posture, 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 surface parking is available at the building.

Boulder Biologics

4745 Arapahoe Ave, Suite 300
Boulder, CO 80303

Campus: BCH Foothills Campus
Phone: 720-550-6175
Parking: Free surface parking on site

Get directions → Call the clinic

Want to see the clinic in person?

Schedule a consultation, and a tour.

Most consultations happen in one of our patient rooms; many patients ask to see the lab and procedure room while they're here. We're glad to walk you through.

Or call 720-550-6175