From Service Collections to the Brazilian Network of

Biological Resource Centers

Elisa Cupolillo (CLIOC/FIOCRUZ)Antonio Monteiro (BCRJ/UFRJ) Lilian Praça (NTCB/EMBRAPA)

Paulo Holanda (TECPAR)Lara Sette (CBMAI/UNICAMP)

CBMB(IDA)

Health & Industry

Environment & Industry

BCRJ CBMAI

CLIOC

SICOL IV

Bacilluscollection

FIOCRUZ

UNICAMP

EMBRAPA

UFRJ

Others

servicecollections

INPI/INMETRO

GBRCN

How and why these collections were selected?

•Survey about cell cultures and microbiological collections in BrazilTool:Questionary sent to several collections – 26 answered

• Workshop on Biological Resource Centers and Biological Material conformity accessment – 18 collections presented their scope

•In locu diagnosis to map the quality status, the services provided andthe interest in participating in the project

- 8 collections

Training in the NBR ISO/IEC17025:2001

•New evaluation of the 8 collections previously selected. 4 collections selected to compose the Brazilian

network

Biological material• Bacteria, yeasts and filamentous fungi and GMO: risk groups 1 and 2 • Number of microorganisms in the collection = ~ 1.000 strains

Service collection at CPQBA/UNICAMP specialized in distribution,preservation, characterization and identification of microorganisms and

microbial communities from environment and industry.

Research areasPreservation, Molecular Ecology, Genomic and metagenomic; Isolation, screening and bioprospection; Systematics

Brazilian Collection of Environmental and Industrial Microorganisms - CBMAI

Operation and Management• International protocols (CABRI, OCDE, WFCC)• Quality management → implementation process for ISO 17025

• CBMAI has its own system for management of the information regarding the strains → SIAM

Microbial agents for biological control collectionEMBRAPA Genetic Resources and Biotechology

Biological material•Entomopathogenics Bacteria

– 350 B. sphaericus– 1.900 B. thuringiensis

•Entomopathogenics Fungi•Fitopathogenics Fungi•Entomopathogenics Virus

ResearchIsolatation and characterization of strains that present different characteristics or

produced new entomotoxic proteins

Services• Isolation

• Samples from different regions• Soil, water, dead insects

• Efficiency determination (bioassays)• Quality control of biological products

• Determination of contaminants presence• Characterization – morphology, biochemistry and molecular• Conservation

• Training Bt products use for Aedes aegypti control• Field events - Farmers from regions around Brasilia

RIO DE JANEIRO CELL BANK (BCRJ)Universidade Federal do Rio de Janeiro

• Since 1980 - Chemical Institute /UFRJ

• ● N2 Freezing

• ● Cellular types:• Human• Mammal• Insect• Fish

BCRJ SERVICES

• Deposit, preservation and distribution of cell lines.• Primary culture development. • Monoclonal antibodies production. • Microbiological contaminants identification.• Mycoplasma detection: PCR and fluorescence.• Mycoplasma elimination.• Cell toxicity tests.• Biocompatibility tests In vitro . • Training in basic and advanced cell culture manipulation.• Cell lines characterization. • Advice and technical support in cell culture. • Cell immortalization.

Leishmania Collection from the Oswaldo Cruz Institute (CLIOC)

Biological material• Leishmania spp. = ~ 1.500 strains, representing different endemic region (mainly

Brazil) and different sources

Research, reference and service collection at Fiocruz specialized in isolation, distribution, preservation, characterization and

identification of Leishmania spp.

Research areasPreservation, Molecular Epidemiology, Diagnose, Genomic and Proteomic

Operation and Management• International protocols (CABRI, OECD, WFCC)• Quality management → implementation process for ISO 17025

21,6

20,8

23,3

35

68,8

41,6

78,4

38,4

0 10 20 30 40 50 60 70 80 90 100

EMBRAPA

CLIOC

CBMAI

BCRJ

2006*

2005**

ISO 17025 met requirements (%) after one year of implementation

* ABNT NBR ISO/IEC 17025:2005 requirements (n=125)

** ABNT NBR ISO/IEC 17025:2001 requirements (n=120)

38,4

78,4

41,6

68,8

0 0,85,6

0

61,6

20,8

47,2

31,2

0

10

20

30

40

50

60

70

80

90

100

BCRJ CBMAI CLIOC EMBRAPA

met req. (%) not met req. (%) in implementation process req. (%)

BRC candidates compliance with ISO 17025 in JAN/2007:

Non-applicable or non-defined requirements represent the lacking percentage to 100%.

1.To improve culture cells and microbiological collections aiming capacitate them to work as Biological Resource Centers, providing biological resources for scientific, industrial, agricultural, environmental and medical R&D.

2. To disseminate information about each collection and the services that the selected collections offer.

The Brazilian Network of BiologicalResource Centers

MAIN OBJECTIVES

1. To qualify the four collections to function as BiologicalResource Centers

2. To develop and maintain a software to manager thecollections and their activities

3. To study and disseminate the OECD guidelines aboutthe Global Network on Biological Resouce Centers

4. To qualify the collections on quality system

The Brazilian Network of BiologicalResource Centers

SPECIFIC OBJECTIVES

Consolidating the 4 collections as Biological Resource Center (BRC)

• Construction: CBMAI will change the installations to a new building (380 m2) √

• Quality management → implementation process for ISO 17025 √

• OECD Best practice guidelines for BRCs → implementation process √

• Implementation of new technique for molecular taxonomy √

• Staff training

• Implementation of liquid-nitrogen preservation method

• Acquisition of new strains for industrial applications (reference strains)

• Human resources acquisition

CBMAI

• Improvement of building infra-structure and acquisition of new equipments√

• Quality management → implementation process for ISO 17025 √

• OECD Best practice guidelines for BRCs → implementation process √

• Staff training

• Web-page design

• Human resources acquisition

Microbial agents for biological control collectionEMBRAPA Genetic Resources and Biotechology

• Improving the quality of collections management → implementation process for ISO 17025 √

• OECD Best practice guidelines for BRCs → implementation process √

• Implementation of techniques for authenticity (phenotyping, viability, microbiological and Mycoplasma control) √

• Staff training

• Implementation of liquid-nitrogen preservation method

• Acquisition of new cell lines

• Human resources acquisition

BCRJ

1. Adequacy of infra-structure

2. Compliance with ISO 17025

3. Increment of the collection (acquisition of new isolates)

4. Improvement in the quality of the material maintained under cryopreservation

5. Characterization of all samples by MLEE (zymodeme classification)

6. Implementation of new molecular methods to the characterization and certification of Leishmania strains

7. Informatization

CLIOC

BRC candidates compliance with ISO 17025 in 2008(“ex-situ” evaluation):

93

9895

90

0 0 0 0

7

25

10

0

10

20

30

40

50

60

70

80

90

100

BCRJ CBMAI CLIOC EMBRAPA

Met req. (%) Not met req. (%) in implementation process req. (%)

Next steps• “in-situ” evaluation of Quality System and integration of internal policies/procedures for compliance and match with OECD guidelines;

• measurement of practicality, impact and sustainability of the proposed System;

• find gaps and amendments on it;

• enhance biosecurity procedures;

• work on the consolidation of Conformity Assessment System for Brazilian BRCs with Government Regulatory Authorities;

• improve the provided services meeting customers needs by offering innovative, secure and value-adding services through the Quality Assurance;

The Brazilian Network of BiologicalResource Centers

• Human resources

– Acquisition and training

• Buildings

– Infra-structure for BRC operations

• Management software

• Back-up

• National legislation concerning biological material sampling, using and transportation

– Including biological material import/export processes

Main problems regarding Brazilian BRC consolidation

Financial Support:

OUR MAJOR CHALLENGE

TO GET SUSTAINABILITY