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Turnkey plasma operations

From concept to first shipment, and beyond.

We build complete plasma collection operations, from feasibility to a licensed, staffed, and productive network shipping plasma that meets specification.

  1. 01Feasibility & market
  2. 02Site selection & network design
  3. 03Facility design & construction
  4. 04Equipment & systems
  5. 05Quality system & licensing
  6. 06People
  7. 07Donor program
  8. 08Opening & ramp-up
  9. 09Plasma release & supply
  10. 10Steady state & handover
01 · The challenge

Most plasma projects stall between the stages.

A new collection operation touches feasibility, real estate, construction, equipment, validated systems, quality, licensing, hiring, donors, and supply contracts. Each usually has its own consultant, contractor, or vendor, and no one owns the flow from the first study to the first shipment.

The gaps are where the time and money go: a facility that does not fit the donor flow, systems that are not validated before inspection, a team hired too late, a fractionator contract signed after the plasma is already in the freezer. Every month of delay before licensure is a month of cost without revenue.

02 · Our standard

One team, accountable from start to steady state.

Accountability

One owner of the flow

A single senior team coordinates every stage, contractor, and vendor, so nothing falls between them.

Design

Built backward from release

Every decision is tested against the end point: plasma that passes inspection and meets the fractionator’s specification.

Economics

CPL from day one

Cost per liter is modeled at feasibility and tracked from the first donation, not discovered after opening.

03 · The ten stages

Feasibility to steady state, in one sequence.

Stages overlap where they should. Each one is planned with the next in view.

01

Feasibility & market

Donor population, demand, regulatory pathway, the business case, and a CPL model.

02

Site selection & network design

Locations, capacity per center, number of centers, and the order they open.

03

Facility design & construction

Layout built around donor flow, build-out, utilities, freezers, and storage.

04

Equipment & systems

Collection devices, donor management and record systems with validation, lab and testing interfaces, and cold chain.

05

Quality system & licensing

Procedures, validation, the quality manual, inspection readiness, and approval by the national authority and FDA, EMA, MHRA, or MHLW/PMDA as required.

06

People

Organization design, hiring, medical oversight, and training and competency through the United Plasma Academy.

07

Donor program

Recruitment, donor care, retention, and a compensation model where local rules permit it.

08

Opening & ramp-up

Soft launch and volume ramp, with CPL and release rate tracked from the first day.

09

Plasma release & supply

Fractionator qualification, contracts, logistics, and shipping to specification.

010

Steady state & handover

Management routines, KPIs, an audit cycle, and a team that runs without us.

04 · What you receive

A working operation, not a stack of reports.

Plan

Business case and CPL model

Feasibility, network plan, and the economics behind every decision.

Build

Licensed, validated centers

Facilities, equipment, systems, and a quality system ready for inspection.

Run

A trained team and supply contracts

People in place, donors coming back, and plasma shipping to specification.

Planning a new collection operation?

Start with the feasibility question: where, how large, and at what cost per liter.

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