Sanyo PPLF-4205 User Manual

Integrated Cell

Processing Work

Station — CPWS

PPLF-4205

CPWS Features:

•Cost effective, space-saving solution

for GMP and GTP compliant regenerative medicine and cell therapy.

•Minimizes the expense of a cleanroom laboratory

www.sanyobiomedical.com

My Life. My Work. My Choice.

PPLF-4205

SANYO CPWS Integrated Cell Processing Work Station

Minimizes Cleanroom Expense

Self-Contained

Space-Saving

Quick to Acquire and Install

GMP and FDA Compliant for Aseptic Process

User Friendly

Energy Efficient, Green Design

The Essential Work Station for CellTherapeutics

Continued worldwide development of new methods and processes in cell therapy and regenerative medicine requires renewed emphasis on tools and technologies required to establish and maintain aseptic conditions demanded of the clinical environment. SANYO has met that challenge.

In designing the industry’s first viable alternative to a conventional Class 10,000 cleanroom for both Class 100 air quality and barrier isolation, SANYO has introduced the Cell Processing Work Station (CPWS) to bring the potential of cell therapeutics to more facilities while mitigating acquisition and operation costs and protracted time lines.

Global Cell Therapy and

Tissue Engineering Market

2010 & 2015

	Ophthalmalogy and	General
	Organ Replacement/	Cancer
	Preservation
				Cord Blood and Cell Banking
				Cardiology
				Neurology
	Dental/Oral

Skin

Urology

Orthopedics/Spine

Millions of Dollars

$25,000

$20,000

$15,000

$10,000

$5,000

$0

	Cell/Tissue
	Banking
	Cancer
	General Surgery,
	GI, Gyn, Others
	Ophthalmalogy
	Organ
	Dental
	Skin
	Urology
	Ortho
	Neuro
	Cardio
2010	2015

2 CWPS Integrated Cell Processing Work Station www.sanyobiomedical.com

The Market

Immediate beneficiaries of the SANYO CPWS include both private and public institutions serving the life science, clinical, biotechnology and pharmaceutical markets.These include mainstream

and scale-up pharmaceutical companies focused on drug and medical device development related to human cells, medical researchers applying cellular therapies in clinical trials, and hospitals now deploying FDA approved cellular therapeutics to treat a broad range

of diseases.

As the science progresses and results are propagated throughout the medical and scientific community, the need for bench-level research and production is expanding exponentially. As a result, the availability of the SANYO free-standing, self-contained work station apart from the conventional layered cleanroom approach to containment and protection, is bringing the capability for on-site cellular therapeutics to more facilities more quickly and at a lower capital and operational cost, all within the GMP performance envelope required of the cell technology itself.

Self-Contained System, Small Footprint

The SANYO concept of a self-contained work station is enabled by the company’s demonstrated proficiency for in situ decontamination required to separate processes from one patient to the next, or one protocol to another. By using a highly effective H2O2 decontamination process, the CPWS can be completely sterilized without heat and prepared for the next protocol within two hours as compared to a cleanroom decontamination function can take days or weeks.

By increasing throughput within the parameters of GMP compliance and FDA guidelines, the CPWS is deployed for both

research, cellular manipulation and growth, cell product extraction and emerging processes that fall within similar guidelines.

Current and future applications of the CPWS include organ and tissue regeneration such as skin, cartilage, alveolar bone,

cornea, cardiac muscle, nerve, liver and pancreas regeneration. Immunotherapy applications may extend to dendritic cells,T-cells and more.

Making it Work

Improving efficiency in human interaction is a primary design attribute of the CPWS. All work must be performed without human error, in an aseptic environment, and with detailed documentation to assure quality and compliance. Gownup time, expense and inconvenience is minimized or eliminated altogether. Integrated systems within the CPWS permit cellular extraction, preparation, culturing and administration with aseptic assurance as well as economic practicality.

Because conventional autoclaving is not possible, the SANYO H2O2 decontamination process diminishes both time and labor associated with this critical step between patients, positioning the CPWS squarely in the equation for cost/ benefit justification associated with investment decision-making. Allowances for integrated centrifuge, microscopy, data acquisition and incubation functions are important considerations in the CPWS design; a unique docking station permits interface and exchange with unlimited number of cell culture incubators dedicated to individual patients or cell lines.

On the Work Surface

Since humans remain the single most common source of contamination, the CPWS provides both physical and process benefits to minimize contamination and cross-contamination in the work area.Within the four-port glove box the CPWS delivers more than a conventional Class II,Type A2 biological safety cabinet typically installed within a cleanroom to achieve the same objective. Here, the manually initiated, automatically deployed H2O2 decontamination process supplements continuous HEPA filtration. As 0.3 micron particles are removed from the fresh air exchange, H2O2 decontamination neutralizes contaminants brought forth by instrumentation or equipment. A number of sterilization sequences are available to protect the aseptic environ-

ment.

The glove box design offers barrier isolation protection for the operator and the work inside. User comfort and ergonomics are inherent to the CPWS design, including a sloped front for easier access and glare reduction.

WhatYou Don’t Need

The relatively small footprint permits installation into existing or new Class 100,000 lab space with conventional utilities and minimal site preparation.

Multi-layered airlocks in multiple treated rooms are avoided. Capital intensive expenses are lowered and lead times from decision to operation are shortened. Once in place, operational costs are highly contained and predictable, with sterilization available more frequently and at a fraction of conventional cost.

The SANYO Difference

SANYO Biomedical, a division of SANYO North American Corporation, is headquartered in suburban Chicago. For over forty years, SANYO has established a reputation as a premier manufacturer of precision biomedical and laboratory equipment. Known throughout the world as

a leading brand in consumer electronics and appliances, SANYO addresses global needs such as energy, food, housing, healthcare and information technology.

As a part of the SANYO product line worldwide, the Cell ProcessingWork Station exemplifies our uniqueVertical Component Integration™ approach to product development, combining ideas and innovations from our global industrial and consumer products network into an integrated product featuring advanced technology, controls, construction and performance attributes.

The CPWS and subcomponent systems have been extensively tested to meet the toughest quality standards for performance, ergonomics and cost of ownership.The CPWS is designed to minimize its carbon footprint through energy savings and environmental stewardship.

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SANYO CPWS SeriesTechnical Attributes

The SANYO CPWS work station is designed to deliver efficient, costeffective and GMP compliant cell therapy and manufacturing capability without the expense and inconvenience of a class 10,000 cleanroom.The CPWS offers significant advantages over conventional hard wall cleanroom construction.

•The CPWS is less expensive than a cleanroom.

•It is quicker to acquire and place into operation.

•The small footprint increases options for location and orientation.

•The user-friendly glove box design eliminates gowning and improves operator comfort and convenience.

•Operating costs are lower than cleanroom costs

•Work is easily suspended and resumed without the need to de-gown and re-gown, improving user comfort.

•Fast decontamination and changeover improve productivity, increase throughput and deliver quicker return on investment.

•Recordkeeping and process documentation are easier to manage.

Components and operating systems are configured around a central work station with a HEPA filtration and air management system designed to deliver Class 100 air to the work surface within the glove box.

•Central barrier isolator

•Pass box interchange

•Integrated H2O2 decontamination system

•Optional cell observation system with microscope and monitor

•Optional centrifuge integrated into the work surface

•Optional CO2 incubator with docking collar

•The optional incubator and optional centrifuge operate within a Class 100 environment.

CPWS Work Station

The SANYO CPWS work station is a component-based design that permits long-term or quick turnover selfcontained protocols with efficiency and safety for the product as well as personnel. As an integrated system, all functions associated with good laboratory technique, environmental control and

ergonomic comfort are selected for compatibility and complementary functional performance.

1.Modular CO2 incubator, shown on cart, docked to barrier isolator.

2.Incubator cart with locking casters; offset casters nest with

frame assembly when docked.

3.Lid cam latch

4.Centrifuge controller

5.Centrifuge module accessible for the aseptic work area.

6.Glove port

7.Hinged front access assembly; front lifts up when total interior access is required.

8.Interchange pass box with manually

initiated, automatic sequence H2O2 decontamination system.

9.System controller

10.H2O2 liquid supply cartridge

11.HEPA supply and exhaust filtration blower motor assembly

12.Electrical compartment

13.Interior fluorescent lamps

14.Electropolished interior surfaces

15.Angled 6° front for user comfort, reduced glare

16.Locking screws to secure hinged front.

17.Adjustable leveling feet

18.Optional cell monitor LCD

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4 CWPS Integrated Cell Processing Work Station www.sanyobiomedical.com

SANYO CPWS Series Applications

Clinical Applications of Cell Therapies

	Disease States	Cell Therapies
	Cancer
	Hematopoietic Stem Cell	Autologous and allogeneic HSC; Ex vivo expansion of HSC;
	(HSC) Transplantation	‘Suicide’ T-cells – gene transfer; Stem cell transplantation
	Immunotherapy	Dendritic cells; NK/T cells; Macrophage-activated killer cells;
		T-cell expansion; NK cells; Co-stimulatory molecules (gene transfer)
	Orthopedic
		Expanded chondrocytes; Mesenchymal stem cells
	Neurodegenerative Disorders/Trauma
		Adult stem cell-derived cells; Embryonic stem cell-derived neural cells
	Cardiovascular Disease
		Infusion of marrow/blood-derived angio blasts;
		CD34 stem cells; cardiac cells
	Organ Replacement
	Pancreas (diabetes)	Pancreatic islet cells; Embryonic stem cell-derived islet cells;
		Adult stem cell-derived islet cells
	Liver (failure, metabolic disorders)	Bioartificial liver; Isolated hepatocytes; Hepatocyte stem cells
	Kidney (failure)	Bioartificial kidney
	Wound Healing
		Keratinocytes; Skin stem cells
	Infectious Diseases
		Antigen-loaded dendritic cells; Lymphocyte expansion; Macrophages
	Genetic Deficiencies
	Hemophilia	Gene Therapy
	SCID	Gene Therapy
	Cystic Fibrosis	Gene Therapy

Autoimmune Diseases

	Immunotherapy	Dendritic cells; T-cells, Mesenchymal stem cells;
		Lymphocyte expansion; Natural Killer cells

HSC, hematopoietic stem cells; NK, Natural Killer; SCID, severe combined immunodeficiency Currently in clinical studies.

Applications

The SANYO CPWS enables a broader access to cell therapeutics related to both minimally manipulated and nonminimally manipulated cell products by lowering the cost of entry, extending the process to the widest range of applications, and minimizing operating expenses when compared to a conventional cleanroom environment.

•Minimally manipulated products are associated with cell washing, enrichment, selection, HSC (PB, BM, CB), cancer therapies and other under GTP requirements.

•Non-minimally manipulated products are associated with expanded, differentiated or transformed cells (DC, MSC, ESC, TC) in cancer centers, biotech labs, stem cell institutes and contract manufacturing facilities operating under GMP requirements.

•GMPs (Good Manufacturing Practices) are mandated by the United States Food and Drug Administration to ensure that drug development and manufacturing is safe, quality controlled for repeatability and thoroughly documented.

•GMPs typically require expensive hard wall laboratories and laboratory suites using biological safety cabinets in Class 10,000 cleanrooms surrounded by a Class 100,000 room.

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