Product Custom-made biological spill kits

New Personal mentoring for biosafety professionals

Success through effective and efficient implementation and continuous improvement

New Project management & open innovation

Processes streamlined and coordinated through external guidance and supervision

Biorisk & environmental risk assessment

Success through effective and efficient implementation and continuous improvement

Science & technology knowledge management

Trendsetting development through integration and management of novel science and technology

Biorisk & environmental risk management

Safety and security through sound risk assessment and tracking of failure potentials

Training

Business continuity through safe and secure, knowledgeable and responsible personnel

Regulatory compliance & approval

Certainty and efficiency through guidance on regulatory requirements and processes

Technical operation & construction

Continuous facility operation through state-of-the-art equipment, design and control

Audits, reviews & certification

Confidence and credibility through verification of state-of-the-art implementation

Transport

Due-time arrival of biological material through compliance with transport, import and export requirements

Product Custom-made biological spill kits

Biological spill kits are the problem solvers to have when incidents happen despite all precautionary measures. Ever wondered about what goes into a biological spill kit and where to find the components quickly and in the right quantities and qualities without too much effort?

Tell us about
  • The type of work you do
  • The type of spills you expect
     
  • The type of microorganisms you use
  • The distribution and level of laboratories and ancillary rooms
and we assemble the adapted spill kits with respect to content,
size and number for you.

For specific information and ordering please contact us at info@jenaplartners.ch or
+41 79 652 92 17.

New Personal mentoring for biosafety professionals

Biosafety and Biosecurity in a life science institution is inextricably linked to the competence of the Biosafety Professional in charge. Yet, as of today, there is no university degree or otherwise encompassing adequate education or coaching for Biosafety Professionals that is specifically geared towards their needs for knowledge and competence and the needs of their respective institutions.
We close this gap by a customized mentoring for Biosafety Professionals in order for them to reach professional excellence in an efficient and effective way to be able to perform with confidence and success in their specific environment.

Our services

  • Comprehension of biosafety and biosecurity roles and tasks
  • Compilation of adapted training programs and methods to achieve professional competence
  • Specific knowledge in biosafety and biosecurity
  • Understanding of juristic language and regulatory requirements

Special offers

  • Application of networking tools
  • Optimisation of communication skills
  • Training in how to train others
  • Resource management
  • Physical and psychological stability and fitness

New Project management

Adaptation of processes to latest innovation, development of new research strategies, merger of activities, construction and reconstruction of facilities, reorganisation of personnel? Any processes involving different actors with different backgrounds and expertise can be streamlined by bringing in external management and supervision with an objective point of view.
Jenal & Partners know what it takes to build consensus among diverse stakeholders, and to have them buy into the process and into efficient collaboration, even if coming from different backgrounds, institutions and countries.

Our services

  • External project management
  • Support of internal project management
  • Development of project charters

Special offers

  • Evaluation of project risks
  • Coordination of the interaction of project teams
  • Chairing of consensus-building meetings

Biorisk & environmental risk assessment

When business continuity is paramount, the awareness and assessment of the risks that might hinder it, is indispensable. A sound risk assessment allows for appropriate risk management to mitigate the risks to an acceptable level both with respect to internal policies as well as legal requirements.

Our services

  • Risk assessment of the whole range of organisms in research, development and production including attenuated strains and,viral vectors and inserts with hazardous potential
  • Risk assessment of nanoparticles in conjunction with biological material
  • Risk assessment on the dual-use potential of biological material
  • Risk assessment of gene therapy products for clinical trials and market authorisation with emphasis on environmental risks
  • Risk assessment of deliberate release and market authorisation of genetically modified (micro)organisms
  • Risk assessment of practices, processes and technical features of facilities

Special offers

For Swiss institutions we provide

Science and technology knowledge management

Success in business through trendsetting development requires consideration and integration of latest developments in science and technology and interaction with the right partners. To find and evaluate the applicability of exactly the information that is needed for specific research and development goals is often a real hurdle and time consuming.
Jenal & Partners closely follow latest developments in science and technology, with particular focus on topics and actors in synthetic biology, gene therapy, advanced medicinal products and multidisciplinary projects such as nano(bio)technology.

Our services

  • Literature and progress reviews as well as the evaluation of specific advances in science and technology
  • Support in open innovation processes
  • Support in network generation and partnering between academia and industry
  • Support with regulatory compliance issues and interaction with regulatory bodies

Gene therapy and advanced medicine

  • Support with clinical trial and marketing authorisation applications
  • Environmental risk assessment
  • Mediation between applicants and authorities

Nanobiotechnology and nanomedicine

  • In collaboration with our partner TEMAS
  • Risk consideration of nanoparticles and biological material and combinations thereof
  • Principles and practices of safe handling
  • The bringing together of expertise required for multidisciplinary projects, profiting from our large network in both biotechnology and nanotechnology.

Biorisk and environmental risk management

For institutions working with biological materials the risks associated with these activities have to be managed in order to control personnel exposure, to prevent the accidental or unintentional release of biological material into the environment as well as to avoid the intentional misuse of this material.
Jenal & Partners support the design and implementation of adapted biorisk management system which allows for adequate measures, processes and resources (including risk assessment, responsibilities, safe practices and procedures) in a structured and integrated manner, which reflects the overall formal intentions and directions of an institution related to biosafety & biosecurity.

Our services

  • Design of biorisk management systems according to the CWA15793 Biorisk Management Standard
  • Integration of biorisk management into ISO14001, ISO9001 or OSHAS18001 management systems
  • Design of ISO14001 environmental management systems
  • Design of biosafety concepts accoring to Swiss regualtory requirements

Services typically include

  • Review of the activities and practices
  • Proposal of an overall concept
  • Development of the system
  • Implementation of the system, including training
  • Specific technical guidance or evaluation of existing biorisk management systems
  • Periodic update
  • Specific technical guidance or evaluation of existing biorisk management systems

Training

Prevention of incidents and accidents with biological material in both academia and industry is only possible with personnel knowledgeable in biosafety and biosecurity principles and practices.
According to their specific function in an institution, all personnel, be it students or managers, need to be provided with adapted knowledge through custom made training ranging from risk assessment, administrative procedures and codes of responsible conduct, to best practices, technical measures and safety equipment.
Furthermore, biosafety professionals need to be trained to train people in the groups for which they are acting as biorisk management advisors.

Our services
  • Basic biological safety and security training
  • Training on specific issues related to specific activities of an institution
  • Specialised training and coaching for biorisk management advisors
  • Hands on training on matters where practical experience is of prime importance, such as biosafety practices or emergency procedures
  • Training related to the implementation of a biorisk management system
  • Design of biosafety training handbooks and materials
  • Train-the-trainer workshops
  • On-site and individual support and introductory courses for new biorisk management advisors

Regulatory compliance and approval processes

Application of cutting edge science and technology might be linked to considerable uncertainties with respect to regulatory requirements. Nonetheless it is crucial for successful research and business development.
Activities in life science are regulated in a wide range of national or regional regulatory documents as well as international standards and guidelines.
We have inside knowledge on the regulatory requirements and notification procedures in the European Community and in Switzerland. and maintain direct contact with regulatory agencies and enforcement bodies within Europe.

Our services

  • Information and updates on regulatory requirements
  • Support in compliance through efficient and effective practical solutions
  • Facilitation of interaction with regulatory bodies
  • Support in the harmonisation of practices for internationally acting institutions

Special offers

Technical operation & construction

A well designed biocontainment facility is not only one that meets a number of technical requirements but also provides an effective support to efficient and safe operations. The solutions we propose are pragmatic, well-adapted to a given situation and compliant with regulatory requirements.

Our services

  • Support with the design and operation of laboratories, greenhouses, production facilities and animal facilities
  • Advising prior to or during the design involving all operational, safety and security aspects, including GLP, GMP, ...
  • Support in the commissioning phase to check the performance of devices that are critical for biosafety

Special concerns

  • Safe work practices and work procedures
  • Personal protective equipment
  • Biosafety cabinets and other equipment to prevent or limit exposure to biological material
  • Disinfection and decontamination potocols
  • Solid and liquid waste management
  • Emergency prevention and response
  • Biosecurity and bio-preparedness

Audits, reviews & certification preparation

When one needs to be sure about the completeness and correctness of one’s risk assessment, risk management and regulatory compliance an objective, unbiased, external view brings the necessary additional reflection.
We are familiar with the needs of research institutions and industry with respect to internal audits and the preparation of external inspections and maintain contacts to the relevant enforcement bodies.
Ursula Jenal also acts as auditor for certification of biorisk management systems and environmental management systems for SGS Société Générale de Surveillance

Our services

  • Gap analysis of internal biorisk and environmental management programmes
  • Technical reviews of safety and security practices and measures
  • Compliance audits against national regulations, international standards or sets of internal policies, standards and procedures
  • Harmonisation of biorisk and environmental management programmes during merger or acquisition processes
  • Evaluation of compliance by a contractor to regulatory requirements or internal standards
  • Preparation for inspections by the authorities
  • Assistance in building and setting up customised internal audit programs

Special offers

Transport

To make sure that biological materials arrive at their destination in due time, international transport regulations (class 6.2 and 9) as well as import and export permits have to be applied for all national and international transports by air, road, rail or sea. Furthermore, specific regulations such as the Cartagena protocol, CITES, bio-defence regulations or others, aiming at safeguarding human health, animals or plants apply to some types of biological materials.

Our services

  • Identifying the regulatory requirements applicable to specific biological materials
  • Defining and finding the correct packaging and labelling
  • Compiling appropriate shipping documents

Special offers

  • Contacting a competent shipper
  • Gathering import and export permits
  • Contacting authorities responsible for the enforcement of transport regulations
 

Success in Biotechnology through Science, Safety & Security

Jenal & Partners Biosafety Consulting was registered in 2001 in Switzerland.

We support you with achieving your business goals and maintaining business continuity by integrating the latest developments in science and technology as well as by adopting internationally accepted standards in risk management, safety and security.

Languages used in the company are English, German and French

JENAL & PARTNERS
BIOSAFETY CONSULTING
Magdenerstrasse 1
CH-4310 Rheinfelden
Phone +41 61 723 28 58
Fax +41 61 723 28 59
Mobile +41 79 652 92 17
mail@jenalpartners.ch
Partners: Ursula Jenal, Philippe Stroot
Collaborators: Patrick King
ursula.jenal@jenalpartners.ch
Mobile +41 79 652 92 17

After obtaining her PhD as microbiologist from the Swiss Institute of Technology (ETH) in Zürich in 1991, Ursula Jenal started her career as a scientist in charge of environmental risk assessment studies at Electrowatt Infra Ltd in Zürich (1991-1992).

With a grant from the Swiss National Science Foundation, she undertook post-doctoral research at the Environmental Engineering & Sciences department of Stanford University, California (1992-1995) and was a visiting research scientist at the Centre for Microbial Ecology, Michigan State University (1995) studying the potential use of genetically modified bacteria for ground water decontamination. She has been lecturing on this subject both at Stanford University and the University of Zürich (1996-2003).

In 1996 she joined the Swiss Agency for the Environment, Forest and Landscape where she acted as co-author of the Swiss Biotechnology Regulations. She was also responsible for the oversight and management of biosafety research projects and for the scientific evaluation of authorisation applications for the use of genetically modified organisms in contained systems, field releases and market products.  

Ursula Jenal has been representing Switzerland at the OECD working group on harmonisation of regulatory oversight in biotechnology. She has been a member of the European Biosafety Association (EBSA) since 1998 and has been acting as elected secretary and member of the council between 2003 and 2007. Today she represents EBSA at the Biological and Toxins Weapons Convention. In 2004 she was invited to participate in the Forum Gene Technology of the Swiss Academy for Natural Sciences.  

In 2001, Ursula Jenal, launched her own Biosafety consulting company offering her expertise in Biosafety & Biosecurity to academia, industry and regulatory bodies.
philippe.stroot@jenalpartners.ch
Mobile +32 484 274 365

Philippe Stroot holds a PhD in biological sciences of the University of Namur, Belgium. After 7 years of academic research at the University of Namur and one year as scientific expert for the Belgian federal administration, he joined GlaxoSmithKline Biologicals (SmithKline Beecham Biologicals at that time) in 1990 as International Vaccine Training Manager.

Appointed Biosafety Officer for the company, Philippe Stroot established and managed the biosafety programme in R&D, Manufacturing and Quality Control from 1993 to 1997. During those years, he worked on harmonising biosafety, radioprotection and waste management practices, realised the first legal registration of the company's biological activities and established their biocontainment design specifications.

In 1997, he was hired as R&D Operations Manager during the construction of GSK Biologicals' main research building. During 8 years, he managed the existing R&D facilities, including more than 10000 m2 of biocontainment laboratories, and acted as the users' representative for the on-going construction projects. He was also in charge of co-ordinating health and safety programmes in R&D.

He then joined GSK Biologicals Corporate EHS team as Global Biosafety Manager. In this position, that he held until the end of 2006, he was in charge of implementing and co-ordinating the Biosafety programme of GSK Biologicals worldwide.

During that period, Philippe Stroot started to work as an independent biosafety expert. He joined Jenal & Partners in 2005.

Philippe Stroot has been a member of the American Biological Safety Association (ABSA) since 1993 and was a founder member of the European BioSafety Association (EBSA) in 1996. He participated to a number of international working groups including the CEN Technical Committee on Biotechnology (TC233) and has recently been representing Jenal & Partners in the CEN Workshop set up to develop a new international biorisk management standard (WS31).

In 2007 Philippe Stroot launched his own Biosafety consulting company, Xibios, located in Belgium.
patrick.king@jenalpartners.ch
Mobile +41 79 770 15 39

Patrick King holds a PhD of the University of Leicester, England, where he worked on the development of continuous culture methods (e.g. chemostats) for plant cell cultures and their use in studying plant hormone physiology.
In 1976 he became Senior Research Group Leader (Plant Genetics) at the Friedrich Miescher Institute in Basel, Switzerland, developping tissue culture methods for maize, methods for the isolation of biochemical mutants via selection in cell culture or seedlings and the cryoprotection of plant cells. He collaborated in the lead up to the transformation of maize in vitro.

Between 1992-2011 he was Biosafety and Radiation Safety Officer at the Friedrich Miescher Institute, Basel, responsible for biosafety and radiation safety organisation, inspection and training for research using plant and animal systems with approx. 200 research personnel in B and C isotope labs as well as in BSL2 facilities and BSL1 greenhouses.

Risk assessment

  • Evaluation of risk assessment of Swiss notifications and authorization applications
  • Environmental risk assessment of gene therapy
  • Risk assessment of activities with nanoparticles in connection with biologicals in nanomedicine
  • Environmental risk assessment of advanced medicinal products

Biorisk management systems

  • Design and implementation of biorisk management programs
  • Integration of biorisk management into ISO9001 and ISO14001 management systems
  • Biorisk management and compliance audits
  • On-site adapted biosafety & biosecurity training
  • Biorisk management system certification (with SGS)
  • Evaluation of environmental biorisk mangement reports for authorities

Design of guidelines

Training

  • On-site practical training in industry and academia;
  • European Biosafety Association, biorisk assessment (2012);
  • European Biosafety Association, status of biosafety professional and their networking (2009);
  • Swiss BSO curriculum, BSL2, biorisk assessment (2009-)
  • Swiss BSO curriculum, BSL2, transport of biological substances (2009-)
  • Swiss Institute of Technology, individual training of newly established biosafety advisor;
  • Programme design, organisation, moderation, training:
  • The annual information meeting for Swiss Biosafety coordinators on 'Basic regulatory and technical principles in Biosafety' (2001-2008); Discussion forum for Swiss biosafety coordinators on 'Technical principles in Biosafety production facilities' (2004); Discussion forum for Swiss biosafety coordinators on 'Scientific principles and risk assessment in biosafety, current topics and emerging issues' (2005)

High containment laboratories

  • Survey on high containment laboratories (positive and negative aspects of combining work with both human and animal pathogens)
  • Expertise on the diagnostics of risk group 4 virus: compilation of the international standards for risk assessment and recommendation of the application of high containment safety measures;
  • Expertise on the risk assessment of activities in medical microbiological diagnostics laboratories and on the corresponding safety measures;

Examples of customers Switzerland

  • Industry: Actelion, Viollier, Arpida, 4-Antibody, Ciba, Crucell, Werthenstein Biopharma, Société Général de Surveillance, SGS
  • Authorities: Federal Office for the Environment, Federal Office of Public Health, Cantonal biosafety authorities, Swiss Federal Expert Committee for Biosafety
  • Expertise on the risk assessment of activities in medical microbiological diagnostics laboratories and on the corresponding safety measures;
  • Academia: Swiss Federal Institute of Technology, University Hospital of Zürich

Examples of customers European Union

  • Industry: Transgene, Amsterdam Molecular Therapeutics, Sanofi Aventis, Promega, Medimmune
  • Institutions: European Biosafety Association, Sandia National Laboratories, CYMMIT International maize and wheat improvement center
  • Academia: University of Luxembourg

Collaborations

  • Xibios SPRL, biosafety consulting services
  • Cossgan business development and risk management methodology
  • Biolytix, molecular and microbiological analyses
  • TEMAS, planning and implementation of innovations in industry with focus on nanotechnology
  • Biosafety & biosecurity experts, internationally

Participation in international activites

Memberships