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GDCC_P.PARDON

GSK Biologicals Distribution & Cold Chain

October, 2008

Muriel Balthazar

Global Distribution Leader

Sébastien Wins

Cold Chain Strategy Specialist

GDCC_P.PARDON

Purpose of this talk

Present an example of how a vaccine manufacturer manages his cold chain

distribution

Express what our expectations from the suppliers are and what limitations

we face (suppliers’ constraints)

… and above all, exchange views to understand what the future cold chain

transport could be like

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Topics

Short introduction on who we are…

Explain our cold chain strategy

Questions and discussion

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GSK Biologicals in 2007

1.1 billion vaccine doses produced

Over 30 marketed vaccines available worldwide

Over 20 vaccines in clinical development

Over 9,000 employees worldwide

Over 1,600 passionate scientists

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GSK Biologicals Network

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GSK Biological distribution out of belgium

2006 total transportation ex-Wavre - 70% air / 30% road – DIRECT but some MMW

To 170 countries

#deliv Tons

Asia 927 626

Europe Road 1 167 1 220

Europe Air 599 169

MENA/SSA 1 059 554

Latin America 577 497

Canada 60 41

USA 277 503

4 666 3 609

deliv tons

road = 25% 34%

EUR= 38% 38%

US= 6% 14%

200 Tons

200 deliveries

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Cold Chain Importance for GSK Biologicals

Why Cold Chain Strategy is important for

GSK Biologicals?

Our products are all sensitive to temperature

variations

Regulators are increasingly focused on Good

Distribution Practices

All vaccine doses exposed to temperature deviations cannot

be replaced in due time �� Patients not protected in due time

�� Ethical responsibility

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Cold Chain Importance for GSK Biologicals

Why Cold Chain Strategy is important for

GSK Biologicals?

Many manufacturing sites worldwide

could be involved in the different steps

of the production of our products

We ship our products to more than 170

destinations worldwide

Distribution includes many sequences,

involves many parties and many processes.

All these need to be controlled to ensure a proper

distribution of our products in adequate conditions

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1. KNOW YOUR PRODUCT – i.e. VACCINES

All vaccines produced by GSK Biologicals are temperature sensitive products:

Vaccines are sensitive to heat at different degrees – but some excursions can be accepted

Most vaccines are sensitive to freeze – Frozen vaccine has to be rejected

Structure of a normal adsorbed vaccine Structure of a frozen adsorbed vaccine

* Pictures from: Temperature Sensitivity of Vaccines from WHO. Version: WHO/IVB/06.10

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1. KNOW YOUR PRODUCT – i.e. STABILITY(PDA-TR39/2007 Revised version)

Temperature sensitive products must be

shipped in a manner to ensure products will

be maintained within an acceptable

temperature range

Products can be shipped outside their

respective label storage conditions provided

stability data or scientific/technical

justification exists demonstrating that the

Product Quality is not affected

Stability studies should be available to

demonstrate the « robustness » of a product

in case of temperature deviation

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CEVA as worldwide LSP

On site CEVA dedicated team

SLR/LSP frame work describing quality standards

GSK Bio has relationship with air carriers

We believe in a tri-partite partnership to bring cold chain

under control

Concentrate the activities with preferred carriers

Technical Assessment of facilities

Route selection

Prefer direct flights or transits in Europe

Special process handling for Routes at risk (i.e. Thermal

covers, unloading supervision, …)

2. KNOW TRANSPORT – Air Strategy

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2. KNOW TRANSPORT – General overview

General overview of Air Transportation :

we need to understand this complex process to each destination in order to select the proper

route & carrier to that destination

We run a risk assessment of the process to implement adequate solutions/improvements

(SOP’s, packaging, …)

Consolidate shipments

and deliver to

airport

Build/ figure/ Weigh Pallets

Load Aircraft

Offload Re-Config

Transfer DeliveryShipper Consignee

AirlineHandling Agent

Onload Airport

Handling Agent

Offload Airport

Forwarder

Origin Trucking

Forwarder

DestinationTrucking

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2. KNOW TRANSPORT – Process flows

Description of the Distribution Routes (Physical Process Flows)

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Measures

Big gradient depending on position of the recorder!

Temperature stability duringflight

cooler truck cooler Tarmac Flight tarmac/HO coolertransfer

2. KNOW TRANSPORT – Mapping of Routes

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2. KNOW TRANSPORT – Risk assessment

The transport process is a succession of steps which are reoccurring along the

distribution route, transferable from one route to another, unlinked to the carrier and

any other specific details:

PREPARATION

ROAD transport

AIR transport

STORAGE in-transit

RECEPTION

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2. KNOW TRANSPORT – Run Risk Assessment

For each step and activity in the process, a risk assessment matrix defines potential

threats, risks, current measures and additional mitigation plan to bring the route under

control.

Risk Nbr Threats Description Risk description Existing controlsPotential

impact

Likelyh

ood

(L)

Concequenc

e (C )

RPN

(LxC)

Shipment preparation (Reefer truck selection)

Temperature deviation leading to destruction of

part/total truck load

C1 From GSK plant direct to customer

0. Only temperature controlled trucks are used

1. Strong monitoring to correctly assess the quality of the load

and to limit loss in case of localized freeze

2. Use of approved carriers according to SOP

3. For specific business some truck &/or van are v

Business risk 1 1 1

C2 From GSK plant to airport of departure

CEVA trucks are dedicated and validated according to GSKBio

SOP; packaging used for air transportation protects from minor

excursions; monitoring in the shipping boxes

Business risk 1 1 1

C3 From airport to airport or from airport to customerno general rule; packaging is protecting the load for minor

excursions; Monitoring inside the shipping boxes.Business Risk 1 1 1

Truck technical features enables temperature inside

to fluctuates outside required Temperature for period

of time or in places

(inadequate cooling unit, wrong calibration,

unfrequent maintenance, weak insulation, …)

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2. KNOW TRANSPORT – Know the Transport Means

AIRCRAFTS AIR-CONDITIONING OVERVIEW B747-400F

Understand the temperature control/regulation in the aircraft used to ship your goods

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2. KNOW TRANSPORT – Know the Transport MeansTRUCKS

26°C

1.7°C

1.7°C1.1°C 2.8°C 3.9°C

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3. DETERMINE APPROPRIATE – Packaging

Ancillary packaging components/systems must be identified according to the amount

of thermal mass that must be temperature-controlled. The greater the thermal mass,

the less reactive it is to ambient temperature variation.

Ancillary packaging components/systems can be used with the basic transportation

unit to maintain the required temperature

Active systems: systems with active temperature control

Air / Sea freight containers

Refrigerated trucks, …

Passive systems: systems without active temperature control

Insulated containers – expanded polystyrene with or without refrigerants, …

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Contains:

-3 trays of cold packs

-20 x cardboard boxes that containsproducts

External dimensions of the pallet :

Length : 120 cmWidth : 80 cmheight : 158 cm

Internal dimensions of the (20) box :

Dims : 34.2 x 25.1 x 43.1 cm

Weight of shipper : 64.4 kg

Main material

Pallet : polyurethane and

cardboardInternal box : cardboard.

3. DETERMINE APPROPRIATE – PackagingPALLET-SHIPPER CONCEPT – SB20

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Contains:

-trays of cold packs





Dims : 34.2 x 25.1 x 43.1 cm

Weight of shipper : 19 kg

Main material

Pallet : polyurethane and cardboard

Internal box: cardboard.


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Contains:

-trays of cold packs





Dims : 34.2 x 25.1 x 43.1 cm

Weight of shipper : 52 kg

Main material

Pallet : polyurethane and cardboard

Internal box: cardboard.


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3. DETERMINE APPROPRIATE – Monitoring Devices

Different monitoring devices can be used to assess the proper maintain of

temperature during shipments

According to the sensitivity of the products shipped, the route, the mean of

transportation, the ancillary packaging and Regulation requirements, a

combination of monitors can be used

Different types of temperature monitors exist:

Mechanical Monitors

Electronic Monitors

Chemical Monitors

They are the “key” to assess the Quality of a shipment regarding the

temperature during a shipment

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Mapping with several probes

Empty load during OQ

Full load during PQ and requalification (each year)

Calibrated probes

Regulation probes (near compressor)

Monitoring probes (within the room)

Continuous monitoring

Electronic chart

Mechanical chart

System Alarmed

Contingency procedure

Training practice (door closed,….)

Preventive maintenance – anticipate issues

3. DETERMINE APPROPRIATE – Facilities

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3. DETERMINE APPROPRIATE – Assessments/Trainings

• Audits of airports and handling agents are a key factor for a better understanding of the route used

and issues that could occur during shipment of your products

• Examples of topics that can be checked during these audits:

• Cold Rooms ( validation, calibration, cleaning, records, …)

• Process flow (inbound, outbound, storage, handling, …)

• Documentation (temperature records, validation, …)

• Training

• Facilities

• Training of the different parties involved in the distribution chain about the importance of the Cold

Chain maintain is also an important factor to consider in order to decrease the risk of temperature

deviations

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• Fly as booked

• Ship sooner/later �� transit could be put at risk or Local not ready

• Split of the shipments ��no consistency of batch or no proof of

Temperature

• Have cold chain under control

• Minimum time on tarmac

• Immediately in cool room with right T° setting

• Temperature controlled truck with correct loading practices

3. DETERMINE APPROPRIATE – Logistics & communication process

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• Adequate track and trace system

• report immediately any deviation and wait for GSK “GO” to act

• details are needed (time&T°) when deviation reported

• Have a good pre-advise system

• … to allow for a quick pick-up of the goods at destination

• if possible anticipate customs clearance

• Efficient local organization

• Quick pick-up - shorter time at airport as possible

3. DETERMINE APPROPRIATE – Logistics & communication process

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