Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 4th European Biopharma Congress Vienna, Austria.

Day 2 :

Euro Biopharma 2017 International Conference Keynote Speaker Roger RB Leakey photo
Biography:

Roger R B Leakey DSc, FRGS has been Director of Research of a CGIAR Centre based in Kenya and responsible for research teams working in four ecological zones of Africa developing agricultural systems for subsistence farmers, and Director of Novel Crops Unit and Professor of Agroecology and Sustainable Development at James
Cook University, Queensland, Australia. He has produced over 350 research publications, including two recent books on Multifunctional Agriculture. His personal research on the interface of agriculture, horticulture, forestry, ecology, food science and social sciences has focused on the domestication techniques and strategies for ethnobotanically important tree species appropriate for local implementation in rural communities. He is Vice Chair of the International Tree Foundation in UK and Co-convenor of
the Agroforestry Alliance for Africa.

Abstract:

Statement of the Problem: Tropical agriculture is both failing local people and the environment with serious impacts on
food and nutritional security, poverty, the global well-being of society and the planet. Addressing this problem requires a new
mindset that recognizes the need to reverse the Cycle of Land Degradation and Social Deprivation that drives the complex
processes that result in very low and declining yields of staple food crops – creating a Yield Gap.
Methodology & Theoretical Orientation: To achieve this, African smallholder farmers have requested help to diversify their
farming systems with new crops that produce the traditionally and culturally-important food and medicinal products that
their ancestors used to gather from forests and woodlands. Cultivating these nutritious and ecologically important species
producing locally marketable products creates healthier agroecosystems and income generation opportunities; as well as new
business possibilities. Over the last 25 years, techniques and strategies to allow a decentralized and participatory approach
to the rapid domestication of these ethnobotanically important species have been applied and implemented in over 500
communities in Cameroon.
Findings: The results have been very positive and are being increasingly adopted and up-scaled; involving some 50 species. 1.
Communities can select individual trees with desirable traits from among the 3- to 10-fold intraspecific variation available at the
village-level. 2. These species are high amenable to simple, low-technology horticultural techniques for cultivar development
that can be implemented at the village level. 3. Participating communities have reported numerous social and economic
benefits from the domestication and cultivation of these species: and, in parallel, increased staple crop yields resulting from
improved soil fertility and health.
Conclusion & Significance: There are great opportunities to develop new tropical crops producing culturally important foods
and traditional medicines to transform subsistence agriculture and the lives of local people and benefit the global environment.

Keynote Forum

Amots Dafni

Haifa University, Israel

Keynote: Medicinal plants of the Bible - Past, present and future
Euro Biopharma 2017 International Conference Keynote Speaker Amots Dafni photo
Biography:

Abstract:

The Holy Land is located in the cultural continuum between ancient Egypt and Mesopotamia. It is logical to assume that
the main medicinal plants used were similar throughout this region. The main species were represented in the families
Solanaceae and Lamiaceae. However, references to medicinal plants in the bible are uncommon and do not reflect the longterm
and regular uses of these plants. While many plants mentioned in the bible have and had medicinal uses most are not
mentioned within a pharmacological context within sacred verses. The main medicinal in the bible are hyssop, myrtle, myrrh,
Balm of Gilead and mandrake. The first four have other ritual uses. The present day use of the plants will be surveyed to
compare them to their ancient applications over the Middle East. It appears that the only plant group that has a pharmacological
future, as a potential source of bioactive compounds, is the species complex known as myrrh (Boswellia spp.).

Keynote Forum

Halina Baran

Karl Landsteiner Research Institute for Neurochemistry and Neuropharmacology, Austria

Keynote: Lowering of kynurenic acid formation – anti-dementia drugs
Euro Biopharma 2017 International Conference Keynote Speaker Halina Baran photo
Biography:

Abstract:

Kynurenic acid (KYNA) is an endogenous metabolite of the kynurenine pathway of tryptophan degradation and is an
antagonist of the glutamate ionotropic excitatory amino acid and of the nicotine cholinergic receptors and its involvement
in memory impairment has been suggested. The therapeutic effect of Cerebrolysin treatment of dementia and of brain injury
has been proposed because of neurotrophic properties of this compound. Since an increased kynurenine metabolism has
been shown in several brain pathologies including dementia we investigated the biochemical properties of Cerebrolysin with
respect to KYNA formation in an in vitro study. The activities of the KYNA synthesising enzymes kynurenine aminotransferase
I, II and III (KAT I, KAT II, KAT III) in rat liver, and rat and human brain homogenates were analysed in the presence of
Cerebrolysin. Data revealed demonstrate the ability of Cerebrolysin to lower KYNA formation in homogenates. We suggest
that the anti-dementia effect of Cerebrolysin observed in Alzheimer patients could be due to Cerebrolysin induced reduction
of KYNA levels, thus enhancing the cholinergic and glutamatergic neurotransmissions. D-Cycloserine, anti- mycobacterial
drug, known as a partial agonist at the glycine modulatory site of the glutamatergic NMDA receptor, exerts anticonvulsive
activities and improves cognitive function. We evaluated the action of D-cycloserine with respect to the biosynthetic machinery
of KYNA synthesis. Interestingly, we found that D-cycloserine blockes significantly KATs activities in rat liver and brain
homogenates and in the frontal cortex homogenate of human post mortem tissue, as well. These results allowed us to propose
that lowering of KYNA content likely due to D- cycloserine inhibition of KATs activities might be involved in the postulated
mechanism for D- cycloserine to act as a partial agonist at the glycine site of the NMDA receptor. It is reasonable to believe
that this mechanism(s) is in part responsible for the improvement of symptoms like dementia, cognition and/or delusion
in schizophrenia patients, Alzheimer’s, HIV-1 infected patients or Parkinson’s patients. Finally we evaluated the action of
Jerusalem balsam with respect to the biosynthetic machinery of KYNA synthesis. Jerusalem balsam is widely used because of
good reputation as a natural remedy. It is a mixture of certain plants, which supposes to have antibacterial and anti-oxidative
properties. Jerusalem balsam is used to improve liver and lung diseases, as for example bronchopneumonia. Interestingly,
we found that Jerusalem balsam blocks significantly KATs activities, too. Lowering of KYNA synthesis by Jerusalem balsam
represents notable biochemical effect since it might influence KYNA levels. Therefore increased KYNA levels observed in
stroke patient, in patient with respiration and cardiovascular problem, in neuropsychiatric disorders, in patient infected with
HIV-1 and patients with bronchopneumonia could be treating by Jerusalem balsam. We speculate the possible therapeutic
application and advantage of the remedy Jerusalem balsam, i.e. mixture of plants and discuss comparing to effect of antidementia
drugs D-cycloserine and Cerebrolysine.

Euro Biopharma 2017 International Conference Keynote Speaker Geert C Mudde photo
Biography:

Geert C Mudde received a PhD in Immunology from the University of Utrecht in 1985 and started his international professional career at the Swiss Institute for Asthma and Allergy Research in Davos in 1989. In 1992, he joined the Pharmaceutical/Biotech Industry, where he held several Senior Management positions at the Novartis Research Institute in Vienna, Austria, the Parke Davis Research Institute in Fresnes, France, Ingenium Pharmaceuticals, Martinsried, Germany, and at Igeneon AG, Vienna, Austria.Finally, in 2006, while joining Baxter BioScience in Vienna as Interim Manager, he co-founded the biotech company F-star Biotechnology. In 2009, together with ChristofLanger, he started to develop the S-TIR™ technology platform for human specific therapeutic vaccines which led to the foundation of S-TARget therapeutics GmbH in 2010,and the spin-off companies OncoQR ML GmbH (2013) and TYG oncology Ltd. (2013). He serves as CSO and Managing Director for OncoQR ML.
 

Abstract:

OncoQR develops therapeutic cancer vaccines based on the S-TIR™ technology platform. Vaccines from this platform are
(non-)human specific and able to induce strong polyclonal B cell and T cell immune responses against tumour associated
(auto-)antigens. Two prototype vaccines, TYG100 and OQR200 resp., have reached in vivo proof of concept in non-human
primates (NHP). S-TIR™ vaccines consist of 2 modules, the disease specific module, “immunogen” and the generic module,
“warhead”, which directs the vaccines to CD32 on antigen presenting cells, especially pDCs and B cells and optimally activates
these cells1. The immunogen of TYG100 is G17, a growth factor for pancreatic cancer cells2 The immunogen of OQR200
targets and contains HER2/neu, overexpressed in ~20% of all breast cancer patients. TYG100 was tested as monotherapy and in
combination with gemcitabine. OQR200 were tested as monotherapy and in combination with TYG100 in a cross over study.
Four immunizations were given 2-3 weeks apart antibody titres were measured on a weekly basis. Under normal conditions no
clinically relevant immune responses can be induced against autoantigens. However, in combination with the warhead, thanks
to intrinsic check point control, all treated NHP (n=44) generated very strong and rapid dose dependent auto-antigen specific
antibody (IgG and IgA) and T cell responses. Two weeks after the 2nd immunization all animals were seroconverted. Despite
very high antibody titres no side effects were observed. Animals, sequentially treated with OQR200, TYG100 and OQR200
showed that the induced responses were 100% vaccine specific, resulting in animals with very high antibody titres against
2 different autoantigens at the same time. All responses are reversible and can be boosted. S-TIR™ vaccines do not induce
autoimmune disease and are tumour specific while optimally mobilizing both arms of the immune system. The immune
response can be fine-tuned on a patient to patient basis.

Euro Biopharma 2017 International Conference Keynote Speaker Kang Choon Lee photo
Biography:

Biography
Kang Choon Lee is Haengdan Distinguished Professor at the SungKyunKwan University (SKKU), Korea, and was Director of the Center of Excellence for Future Pharmaceutical Education and Research in the College of Pharmacy at SKKU. He served as a Professor and Dean at the College of Pharmacy as well as the Director of the Institute of Pharmaceutical Science. Prior to joining SKKU in 1992, he was a Principal Scientist at Dong-A Pharmaceutical Co. for ten years before joining Chonnam
National University as a Professor of Pharmacy. For over 30 years, his Drug Targeting Laboratory has focused on immuno-targeting including immunotoxins, preformulation
and bioconjugation of peptide and protein drugs. He is internationally recognized as one of the leading experts in site-specific peptide/protein PEGylation and firstly
demonstrated the therapeutic potential of novel site-specific PEGylated drugs such as GLP-1 and TRAIL. He served as President of the Korean-American Pharmaceutical
Scientists Association and Vice-president of the Pharmaceutical Society of Korea and Korean Society of Pharmaceutical Science and Technology. He is a recipient of the
Distinguished Pharmaceutical Scientist Award from the Pharmaceutical Society of Korea in 2002 and honored as a Fellow of the American Association of Pharmaceutical
Scientists (AAPS) in 2003. He currently serves on the Editorial Advisory Board of many international scientific journals including Pharmaceutical Research, Pharmaceutical
Development and Technology, PharmSciTech, Journal of Drug Delivery and Heliyon. For clinically translating and commercializing of site-specific PEGylated peptide/
protein drugs developed by his laboratory, he co-founded B&L DeliPharm, Korea and Theraly Pharmaceuticals, USA.
 

Abstract:

TNF-related apoptosis-inducing ligand (TRAIL) is a member of the TNF cytokine family capable of inducing apoptosis by
its cognate receptors in cancer cells without apparent toxicity to normal cells. TRAIL has been considered as an anticancer
drug due to its unique ability to selectively induce DR-mediated apoptosis in transformed cells. To date, recombinant human
TRAIL and antibodies directed against TRAIL-R1 or TRAIL-R2 have been tested clinically. However, these have been
disappointing, showing a very limited benefit as an antitumor agent basically due to their poor agonistic activity of these
agents. And in recent years, the physiological importance of TRAIL has expanded beyond being a tumoricidal molecule to
one critical for a number of clinical settings - ranging from fibrosis and autoimmunity to cardiovascular anomalies. In an
attempt to overcome the poor agonistic activity and also low stability and solubility of rTRAIL in vivo, we developed a delivery
system by using PEGylation. PEGylation of protein improves solubility, reduces the interaction with blood cells and serum
proteins, provides a better biocompatibility, and extends circulation times. We recently confirmed the therapeutic efficacy of
this prolonged systemic TRAIL in vivo on different animal models. In this talk, I will introduce how our research experience,
at the crossroads of bioconjugation, drug delivery, and biology, enabled the engineering of stable TRAIL-based therapies,
the discovery of clinically viable targets for cancer, inflammatory, fibrosis and autoimmune disease therapy towards clinical
translation.

  • Latest Trends in Ethnopharmacology | Ethnopharmacology of Alkaloids | Ethnoveterinary Medicines | Pharmacognosy and Phytochemistry | Applied pharmacology | Cardiovascular Pharmacology | Ethnobotany | Ethnopharmacy | Biologics and Biosimilars

Chair

Anupam Bishayee

Larkin University, USA

Session Introduction

Spiro M Konstantinov

Medical University of Sofia, Bulgaria

Title: Antineoplastic activity of cannabidiol containing products
Biography:

Abstract:

Malignancies are the second cause of death in humans worldwide. Despite many newly introduced and approved targeted drugs,
the problem of multidrug resistance and serious side effects remain unsolved and open the search for effective natural products
with fewer side effects. Curcumin is a practically non-toxic compound of plant origin with own antineoplastic and NF-kB inhibitory
activities. Curcumin is one of the most popular drugs derived from Ayurveda traditions. We investigated the cytotoxic activity of
curcumin loaded electrospun mats in human hepatic and colon carcinoma cell lines (HEP-G2 and HT-29). Disks with 5 mm diameter
of the electrospun mats caused nearly 80% inhibition in HT-29 colorectal cells. The efficacy against the HEP-G2 hepatocellular
carcinoma cells was weaker. The mats showed antibacterial features and were found to be biocompatible with human tissues of different
origin. The tested polymeric mats increased the accumulation of curcumin inside of the malignant cells as estimated by fluorescent
microscopy. One of the polymeric mats represents fully water soluble form of curcumin that may have distinct pharmacokinetic
advantages. Taken together our experimental findings indicate that the non-toxic yellow pigment curcumin after inclusion into
electrospun polymeric mats can be used for topical treatment of liver lesions (e.g. colorectal cancer metastases) and these results are
promising in terms of further clinical application.

Biography:

Abstract:

Cutaneous T-cell lymphoma (CTCL) is an orphan disease which primarily affects the skin by clonal accumulation of neoplastic
T-lymphocytes and is characterized by a 5-year overall survival of 32% of the patients, if the skin is involved and only 7%
for extracutaneous involvement. CTCL therapy is challenging, often empiric because of the limited insight into the genetic basis
and single drug therapy is usually not applicable. Curcumin is one well-known ethnopharmacological non-toxic drug with
limited bioavailability. The objective of our study was to investigate new treatment modalities for targeting CTCL by combining
nanoencapsulated curcumin with alkylphosphocholines thus affecting malignant cell proliferation, skin inflammation and related
infections. The nanoparticle size and zeta-potential of Nano-systems containing curcumin were determined by photon correlation
spectroscopy and electrophoretic laser Doppler velocimetry. Curcumin concentration was measured by HPLC. MTT- (ISO 10993-5)
and CFU-assays were performed on CTCL cell lines for evaluation of cell viability and clonogenicity. Cell death ELISA, microscopy,
Hoechst staining and Western blotting were used to monitor hallmarks of apoptosis. Antimicrobial activity was evaluated by ISO
20776-1:2006 (E). Chou & Thalalai software and response surface analysis of combination effects were used to design the experiments
and to estimate drug-drug interactions. The nano-sized curcumin delivery systems were prepared using two copolymeric carriers
with diameter less than 200 nm and negative surface charge. Encapsulated curcumin penetrated through the cell membranes of
CTCL cells faster than curcumin solubilized in ethanol. Combination effects were evaluated as additive to slight synergistic. We have
observed in treated samples induction of apoptosis and modulation of PKB/Akt and related signal proteins. Erufosine has exhibited
bacteriostatic activity against Gram-positive bacteria in concentrations ranging from 32 up to 100 μM. Combination of erufosine
with nano-sized curcumin has led to bactericidal effect. Taken together, our experimental findings clearly indicated that properly
designed combinations of curcumin with alkylphosphocholines may show higher antineoplastic potential than single compounds
and could be beneficial for the treatment of CTCL as orphan disease.

Biography:

Abstract:

Objective: The objective of the study is to investigate the synergistic effects of Chuanxiong-Chishao herb-pair (CCHP) on promoting
angiogenesis in silico and in vivo.
Methods: The mechanisms of action of a herb-pair, Chuanxiong-Chishao, were investigated using the network pharmacological and
pharmacodynamic strategies involving computational drug target prediction and network analysis, and experimental validation.
A set of network pharmacology methods were created to study the herbs in the context of targets and diseases networks, including
prediction of target profiles and pharmacological actions of main active compounds in Chuanxiong and Chishao. Furthermore, the
therapeutic effects and putative molecular mechanisms of Chuanxiong-Chishao actions were experimentally validated in a chemicalinduced
vascular insufficiency model of transgenic zebrafish in vivo. The mRNA expression of the predicted targets was further
analyzed by real-time polymerase chain reaction (RT-PCR).
Results: The computational prediction results found that the compounds in Chuanxiong have antithrombotic, antihypertensive,
antiarrhythmic, and antiatherosclerotic activities, for hypoxic-ischemic encephalopathy, ischemic stroke, myocardial infarction and
heart failure.In addition, compounds in Chishao were found to participate in anti-inflammatory effect and analgesics. Particularly,
estrogen receptor α (ESRα) and hypoxia-inducible factor 1-α (HIF-1α) were the most important potential protein targets in the
predicted results. In vivo experimental validation showed that post-treatment of tetramethylpyrazine hydrochloride (TMP•HCl) and
paeoniflorin (PF) promoted the regeneration of new blood vessels in zebrafish involving up-regulating ESRα mRNA expression. Cotreatment
of TMP•HCl and PF could enhance the vessel sprouting in chemical-induced vascular insufficiency zebrafish at the optimal
compatibility proportion of PF 10 μmol/L with TMP•HCl 1 μmol/L.
Conclusions: The network pharmacological strategies combining drug target prediction and network analysis identified some
putative targets of CCHP. Moreover, the transgenic zebrafish experiments demonstrated that the Chuanxiong-Chishao combination
synergistically promoted angiogenic activity, probably involving ESRα signaling pathway.

  • Clinical Trials on Biopharmaceutical Products | Drug Delivery Systems | Therapeutic Biological Products | Drug Delivery System of Biopharmaceutical Products |Drug Delivery System | Biotechnological Products | Drug Disposition & Pharmacokinetics | Pharmacodynamics

Chair

Hiroshi Ohrui

Yokohama University of Pharmacy, Japan

Session Introduction

Géraldine Le Goff

National Center for Scientific Research CNRS, Institute for Chemistry of Natural Products ICSN, France

Title: New compounds from Withania Somnifera with neuroprotective activities. Isolation, structure elucidation bioassays and scale-up production
Biography:

Abstract:

The prevalence of neurodegenerative diseases are increasing worldwide due to extensions in lifespan with more than 2.1 billion
people aged 60 and more in 2030. The most representative diseases are Alzheimer’s disease (AD), Parkinson’s disease (PD),
Amyotrophic lateral sclerosis (ALS), and Huntington’s disease (HD). Available treatments are limited in number and efficacy and
extensive efforts are dedicated to alternative herbal therapy. Among various promising plants, Withania somnifera roots and leaves
extracts demonstrated large spectrum activities on neural dysfunction (common name Ashwagandha). Based on our previous
encouraging results, our ongoing efforts are dedicated to identify new compounds from Ashwagandha and demonstrate their
mechanism of action and their relevance in neuroprotection. Besides the known major constituents, withanolides, withanone and
withaferin, now steroidal components were identified and their biological activity investigated.

Biography:

Chawita Netirojjanakul received her BSc in chemistry from MIT, conducting research in the laboratory of Prof. John Essigmann (MIT) and Prof. Steve Ley
(Cambridge). After graduation, she pursued her interest in science policy and commercialization studying MPhil in Technology Policy at University of Cambridge,
UK, as a Gates Scholar. She received HHMI International Student Research Fellowship to conduct PhD research under the supervision of Prof. Matthew Francis
in the Chemistry Department at UC Berkeley with a focus on "development and applications of well-defined antibody and antibody fragment bioconjugates." She
is a Scientist in Therapeutic Discovery Department at Amgen.

Abstract:

The use of automated high throughput screening in large molecule discovery research still lags behind that of small molecule
discovery. Recently we developed a high-throughput large molecule discovery platform to automate hundreds of bioconjugation
reaction setup in one setting. In addition, given LC-MS is a widespread analytical bottleneck, we also established a high-throughput
mass spectrometry (HT-MS) platform to accurately detect and rapidly quantitate protein conjugates. We showed that our HT-MS
platform can be used to quantitate the extent of covalent inhibitor adducts to a cysteine-containing protein construct (~19 kDa)
and of biotinylated adducts to mAbs and Fc domains (~150 and ~50 kDa, respectively). Sample acquisition time was ~20 seconds
per sample, 10-50x shorter time than traditional LC-MS methods. Site-specific bioconjugation of human Fc domains with cysteine
engineered at different positions were conducted under a matrix of reaction conditions varying equivalents of reductants, oxidants,
and alkylating agents using the high-throughput large molecule discovery platform. Using HT-MS, 4 x 384 well plates were analyzed
in ~8 hours, as opposed to ~11 days using traditional LC-MS. This approach facilitated rapid determination of DAR values for the
reduced and intact huFc domains and selection of optimized conditions for different cysteine-engineered Fc constructs which will be
used in preparation of Fc-peptide conjugates as therapeutic leads.

Biography:

Marcin Pyrski is a PhD student in Bioengineering Team led by Dr. Tomasz Pniewski in the Institute of Plant Genetics, PAS. He completed Engineering and Master’s
degrees in Biotechnology at the University of Life Sciences in Poznań. He had attended one year training in plant micropropagation in Floralab Company. Actually
he is working with plant-based HBV antigens on their expression, functionality and immunogenicity.

Abstract:

The continued HBV high prevalence coupled with deficiencies in vaccination programmes stimulate research on a new type
of vaccines. Potential orally administered plant-based vaccine is highly attractive regarding efficacy, cost-effectiveness and
availability of mass hepatitis B prevention. Freeze-dried oral formulations facilitate elimination of complex purification steps, size
reduction and better stability during storage, as well as ensure controlled administration regime in minimised medical facilities.
Micropropagation of lettuce expressing S-HBsAg was optimised to provide repeatable uniform feedstock for plant-derived oral
vaccine manufacturing. Lyophilisation protocol facilitating successful processing of lettuce leaf tissue containing S-HBsAg assembled
into VLPs (Virus-Like Particles) was developed. Several drying profiles and excipients as well as effects of freezing rate and postprocess
residual moisture were analysed. The profile of 20ºC for 20 h for primary and 22ºC for 2 h for secondary drying as well as
sucrose proved the most efficient stabilisation of S-HBsAg during freeze-drying. The process was highly reproducible (86-97%), and
provided a product with VLP content up to 200 μg/g DW. Atmosphere of nitrogen proved to preserve S-HBsAg VLPs for minimum
one year at temperatures up to 37°C. Low-dosed (5-200 ng) preparation used as oral booster vaccine elicited anti-HBs response in
animals at level of commercial injection vaccine (around 1000 mIU/ml). As a result, a plant-derived semi-product with good longterm
stability and immunogenicity of S-HBsAg was obtained for the definite formulation of oral booster vaccine against HBV.

Biography:

Abstract:

Royal jelly (RJ) has been widely used in traditional consumables and in skin creams and ointments for health promotion. RJ is rich
in bioactive constituents such as jelleines, 10-hydroxy-2-decenoic acid, royalisin as well as the major royal jelly proteins (MRJPs),
all of which have shown antimicrobial effect in vitro. However, the characterization of RJ is far from complete, and the development
of new characterization techniques is allowing the discovery of new compounds. Many new bioactive peptides have been identified
using enzymatic hydrolysis as a tool. Enzymatic hydrolysis of RJ has verified the presence of peptides with anti-oxidant and antihypertensive
activity. In the current work, using bioassay guided fractionation of RJ enzymatic digests; a total of 42 peptides were
identified. The peptides, all belonging to the Apis mellifera genome, were identified using a combination of mass spectrometry
and bioinformatics tools. Bioassay guided isolation led to the isolation and structure elucidation of three peptides with promising
antimicrobial activity. These finding support the use of RJ as food preservative and its potential application as antibiotic.

Biography:

Yannick Elias completed his PhD from Swiss Federal Institute of Technology Zurich (ETH Zürich) in Process Engineering, focusing on continuous heterogonous
reactions and has published several papers in reputed journals. Currently, he works for Janssen Pharmaceutical Development and Manufacturing Sciences
(PDMS) as a Process Engineer, focusing on development for parenterals fill and finish operations. He worked with Janssen for more than one and a half years and
is currently leading the strategic expansion of a large molecule drug product development laboratory.

Abstract:

Particulate matter in parenteral drug products is recognized by Health Authorities as a critical quality attribute. A strong focus of fill
and finish process development is put on the appropriate selection and operation of the filling system to reduce intrinsic particle
formation, often related to shear induced drug product degradation. Rotary Piston Pumps (RPP) have been a standard selection in
Janssen for many years, as they offer a simple, compact and robust design and show a very high dosing accuracy. However, as the
drug product acts as a pump lubricant, the product is exposed to very high shear rates, which in turn can cause enhanced intrinsic
particle formation. Thus, alternative filling technologies, such as peristaltic pumps (PP) or a time-pressure (TP) system, are required
for shear-sensitive products. A TP system consists essentially of a pressurized tank and a pinch valve. Dosing accuracy is achieved by
harmonizing the vessel over pressure and the valve opening duration. To improve the overall product quality during filling of shearsensitive
products, a Quality by Design and Right the First Time approach is chosen to ensure proper equipment operation. For this,
understanding the critical process parameters, risks associated with those parameters and their impact on critical product quality
attributed is crucial. Thus, a Design of Experiment study was performed to identify and characterize the impact of six distinct process
and equipment parameters on different solutions to obtain a Design Space for optimal TP filling operation.

Biography:

Yannick Elias completed his PhD from Swiss Federal Institute of Technology Zurich (ETH Zürich) in Process Engineering, focusing on continuous heterogonous
reactions and has published several papers in reputed journals. Currently, he works for Janssen Pharmaceutical Development and Manufacturing Sciences
(PDMS) as a Process Engineer, focusing on development for parenterals fill and finish operations. He worked with Janssen for more than one and a half years and
is currently leading the strategic expansion of a large molecule drug product development laboratory.

Abstract:

Particulate matter in parenteral drug products is recognized by Health Authorities as a critical quality attribute. A strong focus of fill
and finish process development is put on the appropriate selection and operation of the filling system to reduce intrinsic particle
formation, often related to shear induced drug product degradation. Rotary Piston Pumps (RPP) have been a standard selection in
Janssen for many years, as they offer a simple, compact and robust design and show a very high dosing accuracy. However, as the
drug product acts as a pump lubricant, the product is exposed to very high shear rates, which in turn can cause enhanced intrinsic
particle formation. Thus, alternative filling technologies, such as peristaltic pumps (PP) or a time-pressure (TP) system, are required
for shear-sensitive products. A TP system consists essentially of a pressurized tank and a pinch valve. Dosing accuracy is achieved by
harmonizing the vessel over pressure and the valve opening duration. To improve the overall product quality during filling of shearsensitive
products, a Quality by Design and Right the First Time approach is chosen to ensure proper equipment operation. For this,
understanding the critical process parameters, risks associated with those parameters and their impact on critical product quality
attributed is crucial. Thus, a Design of Experiment study was performed to identify and characterize the impact of six distinct process
and equipment parameters on different solutions to obtain a Design Space for optimal TP filling operation.