Construction of CPC (Cell Processing Center)

MISSION

 

PROCESS

① Determination of manufacturing details

First of all, we will consider what kind of products will be manufactured at the CPC to be constructed.
While listening to the customer’s wishes, we will consider together after considering the current regenerative medicine market situation.

 

For example, the following are the products mainly manufactured in regenerative medicine market.

 

●　Stem cells
●　Stem cell culture supernatant
●　Exosomes (isolation creation)
●　PRP / PRP-FD
●　NK ​​cells

 

② Determination of production capacity

We will consider the monthly production volume according to the customer’s business plan and expected profit.
Since it will be an important basis for judgment in “③ CPC requirements arrangement”, “④ Property selection”, and “⑤ Layout decision”, which will be described later, we will carefully consider it together.

 

③ CPC requirements arrangement

CPC requirements will be organized according to the details determined in ① to ② above.

 

Due to the wide range of requirements, some of them are excerpted, but we will consider the following requirements.

 

●　Type and number of equipment to be introduced
●　Necessity of water supply and drainage
●　Individual air conditioning
●　Temperature control
●　Room pressure control
●　Humidity control
●　Amount of electricity required
●　Property size

 

④ Property selection

We will list and select properties according to the requirements determined in ③ above.
The selection process is not an easy task, as it requires extensive knowledge of building structures and electrical work.
Depending on the policy of the property management company, construction of a CPC may be refused.

 

In addition, depending on the property selected, additional costs such as dismantling the ceiling and rearranging air conditioners and air supply/exhaust ducts may be incurred, which greatly affects the cost of design and construction, so it is an important process in terms of income and expenditure.
Before signing a rental contract, we always conduct an on-site survey by an expert to confirm that the CPC can be constructed.

 

⑤ Determination of layout

We will examine the layout by experts.
This is an important process because the above ① to ④ are intricately related and related to whether or not the CPC can start operating.

 

For example, it is necessary to consider the following items in addition to ① to ④.

 

●　Confirm the flow of people and things based on the water supply and drainage route
●　Existence and position of smoke exhaust window
●　Presence and location of offices and meeting rooms
●　Position of emergency exit
●　Presence or absence of application work to the government

 

⑥ Selection of contractors to design and construct clean rooms

From the companies that can design and construct clean rooms for regenerative medicine, we select the most suitable contractor from the following three points of view.

 

●　Cost (whether the cost is reasonable)
●　Speed ​​(whether the speed is appropriate)
●　Quality (whether achievements are enough)

 

Each company has different service characteristics and areas of expertise.
We have a wide network with them and can select the most suitable supplier.

 

⑦ Selection of equipment and selection of contractors for installation

As with ⑥, each company has different service characteristics and areas of expertise.
We have a wide network with them and can select the most suitable supplier.

 

⑧ Application to the government

We will follow the necessary administrative procedures in accordance with the laws and regulations of the country where the CPC is established.

 

In Japan, when manufacturing specific cell products, it is necessary to undergo a conformity inspection by the PMDA under the Regenerative Medicine Safety Assurance Act.
In order to surely obtain approval through application, it is important to consider the layout in anticipation of the application work.

 

 

CONTACT