Dans le cadre de la journée DEFI, le 19 septembre prochain à l’ESCP, retrouvez les entretiens menés
par Medicen Paris Region vous présentant les thématiques abordées durant cet après-midi.
Premiers entretiens avec Lonza pour l’Atelier de 14h00 : Développabilité ou comment réduire le
risque d’échec d’un candidat médicament (biothérapeutiques ou vaccins) ?
Yvette Stallwood, PhD; Head of Applied Protein Services, Lonza Biologics
1. Can you briefly introduce yourself , your background and your role at Lonza?
My name is Dr Yvette Stallwood and my role is Head of Applied Protein Services. My
background is principally cell & Molecular Biology. In my role I have overall responsibility for
three teams of Scientists delivering a range of services including Bioinformatics, protein
production/cell and molecular biology, and Immunology.
2. Can you explain in what context your offer in terms of risk assessment and developability /
deliverability takes place? Can you give numbers for example?
The Applied Protein Services department offer services which support our Clients with the
late stage discovery/early development of their Biotherapeutic product or Vaccine candidate.
Our services are varied and can be applied to single, lead candidates or to help our Clients
streamline their lead selection process, removing those candidates with the highest risk at an
early stage and focussing attention (and resources) on the lower risk candidates. All services
provided by Applied Protein Services are based on “fee for service”; the team are highly
experienced and very flexible and can tailor activities to meet our Clients requirements.
3. How is this a crucial step in the development process of a new protein?
By knowing as much information as possible about a product as early as possible, our Clients
have the opportunity to make the right decisions about the development of their product,
mitigating risk and minimising costs. For example, many of our customers would be at the
stage when re-engineering of the product could be performed (if required to improve the
developability) with minimal impact on time.
4. What is your methodology and what tools do you have?
We have a number of in silico and in vitro tools which are applied to different aspects of
developability
5. How your work is structured in relation to that of your colleague, Sofie Pattijn?
Sofie is responsible for the Immunology team within the Applied Protein Services
department
Sofie Pattijn, PhD, Senior Scientist Immunology, Lonza Biologics
1. Can you briefly introduce yourself, your background and your role at Lonza?
My name is Sofie Pattijn and my background is Immunology and Biochemistry. My role at
Lonza is Senior Group Leader Immunology, part of the Applied Protein Services division. In
this role I’m responsible for a team of scientists offering several types of In Vitro assays to be
used for the assessment of immunogenicity of biotherapeutics and vaccines.
2. How your work is structured in relation to that of your colleague, Yvette Stallwood?
Dr. Yvette Stallwood is head of Lonza’s Applied Protein Services department in Cambridge.
The APS department consists of three subgroups: Cell and Molecular Biology, Immunology
and Bioinformatics.
3. There is the shutdown of several drug development projects lately, which is caused by a
problem of immunogenicity?
Crossing the so-called ‘immunogenicity barrier’ is still a big hurdle in the development cycle
of certain biotherapeutics and is an important reason for failed drug development. During
the last decades, several products like Trombopoietin (TPO), Ciliary Neurotrophic Factor
(CNTF) and GM-CSF/IL-3 fusion protein were reported to be stopped during development
due to problems related to unwanted immunogenicity. Next to these reported cases, a
significant proportion of drugs in development are ‘killed’ due to immunogenicity issues.
4. At what stage of drug development do you intervene?
Lonza Applied protein Services offers tools to intervene during the stage of drug discovery,
design and development. Our developability toolbox provides an operational framework to
integrate key aspects of quality, manufacturing and safety in the design and selection of drug
candidates.
5. What methodology and tools do you use to conduct your studies?
Several In Vitro systems are used in our department to evaluate an immune response of
biotherapeutic drugs and vaccine candidates. Today, these so called ‘test tube’ experiments
with human cells are the closest representations of the in vivo trials and offer an alternative
for animal studies to predict and assess the immunogenic potential of test candidates. We
have a series of flow cytometry based T cell assays to analyze the cellular immune response
by the screening of proliferation and cytokine production. On the humoral level, we offer an
In Vitro B cell assay to screen for immunoglobulin secreting cells on a single-cell level (ELIspot
technology).
Inscrivez vous à la Journée DEFI et aux différents ateliers en suivant ce lien : http://www.defibiotech-sante.org/evenements.php?onglet=50&present=page_accueil&id=76