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 | SUT Applications in Up – and Downstream Bioprocessing Professor Manuel Carrondo, University Nova de Lisboa, speaking at Stem Cells & Bioprocessing Europe 2012. |
 | Plasma Treatment at Atmospheric Pressure – a Versatile Tool to Modify Substrates with Complex Geometries Dr Kristina Lachmann, Fraunhofer Institute for Surface Engineering and Thin Films, speaking at Stem Cells & Bioprocessing Europe 2012. |
Biosimilars in Developed Countries
GBI Research
The report provides a comprehensive insight into the biosimilar market, and offers market forecasts by geography as well as biosimilar categories. It also provides the drivers and restraints affecting the biosimilars market, as well as the business environment and the key success factors in the global biosimilar industry. In addition, the report describes the regulatory environment in the US, top five European markets and Japan with respect to biosimilars.
Biosimilars in Emerging Economies
GBI Research
Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production
Competitor Analysis: Anti-Obesity Peptides and Biologics
La Merie
The report provides a competitor evaluation in the field of R&D projects with anti-obesity peptides and biologics as of February 2012. Purchase of the downloadable pdf report includes a 6-month online access to the data of the report and any updates since the publication date. The database also contains information about discontinued projects.
3D Cell Culture Trends
HTStec
This market report summarizes the results of HTStec’s second industry-wide global web-based benchmarking survey on three dimensional (3D) cell culture carried out in October 2011.
Preclinical Development of Monoclonal Antibodies and Related Biologicals: Emerging technologies and new therapeutic candidates
Business Insights
This report explains what monoclonal antibodies are, and why large pharmaceutical companies are investing so heavily both in developing such drugs internally and acquiring monoclonal antibody candidates from others. More than 80 popular and emerging technologies are named, explained and illustrated with original full-color diagrams.
Global Biosimilars (Follow-on biologics) Market: An Analysis
Koncept Analytics
The report covers the overview, market size and segmentation of the biosimilars market. The various drivers and the challenges faced by the market are also discussed in detail. The competitive aspect of the market is also highlighted and the key players are profiled with their strategies for this market.
Cell-Based Assays For Biologics Trends 2011
HTStec
This market report summarizes the results of HTStec’s industry-wide global web-based benchmarking survey on cell-based assays for biologics carried out in July 2011.
Innovations in Combating Infectious Diseases: Opportunities in therapeutics and diagnostics through application of proteomics, genomics, nanotechnology, and novel sources of lead generation
Business Insights
This report makes a detailed and comprehensive analysis of the cutting edge of research aiming to reveal how bacteria, viruses, fungi, and prions infect and affect their hosts. It also assesses the new technologies and techniques that are being used to design and develop the anti-infective drugs and diagnostic methods of the 21st century.
Cancer Vaccines & Circulating Tumor Cells (CTCs) 2011 Report
Select Biosciences Ltd
This market report from Select Biosciences presents a comprehensive industry analysis of the cancer vaccines space as well as that of the emerging circulating tumor cells (CTCs) space. These two areas are evolving and expanding driven by the greater emphasis on personalized medicine especially in the cancer/oncology space.
Biosimilars and Biobetters: Positioning for a New Market
Select Biosciences Ltd
As regulatory frameworks for biosimilars development begin to take shape worldwide, there are growing opportunities for generics companies to enter the biologics market, a segment which is uniquely driven by unmet needs, commands premium prices, and continues to outperform the global pharma market.
GBI Research
The report provides a comprehensive insight into the biosimilar market, and offers market forecasts by geography as well as biosimilar categories. It also provides the drivers and restraints affecting the biosimilars market, as well as the business environment and the key success factors in the global biosimilar industry. In addition, the report describes the regulatory environment in the US, top five European markets and Japan with respect to biosimilars.
Biosimilars in Emerging Economies
GBI Research
Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production
Competitor Analysis: Anti-Obesity Peptides and Biologics
La Merie
The report provides a competitor evaluation in the field of R&D projects with anti-obesity peptides and biologics as of February 2012. Purchase of the downloadable pdf report includes a 6-month online access to the data of the report and any updates since the publication date. The database also contains information about discontinued projects.
3D Cell Culture Trends
HTStec
This market report summarizes the results of HTStec’s second industry-wide global web-based benchmarking survey on three dimensional (3D) cell culture carried out in October 2011.
Preclinical Development of Monoclonal Antibodies and Related Biologicals: Emerging technologies and new therapeutic candidates
Business Insights
This report explains what monoclonal antibodies are, and why large pharmaceutical companies are investing so heavily both in developing such drugs internally and acquiring monoclonal antibody candidates from others. More than 80 popular and emerging technologies are named, explained and illustrated with original full-color diagrams.
Global Biosimilars (Follow-on biologics) Market: An Analysis
Koncept Analytics
The report covers the overview, market size and segmentation of the biosimilars market. The various drivers and the challenges faced by the market are also discussed in detail. The competitive aspect of the market is also highlighted and the key players are profiled with their strategies for this market.
Cell-Based Assays For Biologics Trends 2011
HTStec
This market report summarizes the results of HTStec’s industry-wide global web-based benchmarking survey on cell-based assays for biologics carried out in July 2011.
Innovations in Combating Infectious Diseases: Opportunities in therapeutics and diagnostics through application of proteomics, genomics, nanotechnology, and novel sources of lead generation
Business Insights
This report makes a detailed and comprehensive analysis of the cutting edge of research aiming to reveal how bacteria, viruses, fungi, and prions infect and affect their hosts. It also assesses the new technologies and techniques that are being used to design and develop the anti-infective drugs and diagnostic methods of the 21st century.
Cancer Vaccines & Circulating Tumor Cells (CTCs) 2011 Report
Select Biosciences Ltd
This market report from Select Biosciences presents a comprehensive industry analysis of the cancer vaccines space as well as that of the emerging circulating tumor cells (CTCs) space. These two areas are evolving and expanding driven by the greater emphasis on personalized medicine especially in the cancer/oncology space.
Biosimilars and Biobetters: Positioning for a New Market
Select Biosciences Ltd
As regulatory frameworks for biosimilars development begin to take shape worldwide, there are growing opportunities for generics companies to enter the biologics market, a segment which is uniquely driven by unmet needs, commands premium prices, and continues to outperform the global pharma market.
Results of the ROTAVAC Rotavirus Vaccine Study in India
Statement of Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health.
BBSRC is Major Partner in Europe-wide Synthetic Biology Funding
BBSRC is contributing €3M as a major partner in a new call for research projects in Synthetic Biology.
Cobra Biologics and Vaccibody Sign Agreement to Manufacture DNA Vaccine
Companies announce agreement to manufacture Vaccibody’s lead DNA vaccine candidate against HPV-induced malignancies.
Cocaine Vaccine Passes Key Testing Hurdle
New anti-cocaine vaccine research shows drug can't reach the brain, human clinical trials on the horizon.
Vectura Establishes Strategic Partnership (Kinnovata) for New Respiratory Business in China
Kinnovata to commercialise products in fast growing Asian respiratory markets.
NIH Scientists Create New Tool for Identifying Powerful HIV Antibodies
It is believed that this latest advance could speed HIV vaccine research.
Bird Flu Expert Working on Vaccine that Protects Against Multiple Strains
As the bird flu outbreak in China worsens, a Purdue University expert is working on vaccines that offer broader protection against multiple strains of the virus.
GSK and Save the Children Partner to Help Africa
Currently, nearly 7 million children under five die every year from preventable diseases.
H7N9: A Novel Influenza Virus and it’s Control
Whilst the virus remains as one primarily circulating in birds, breaking this cycle of replication is the only effective response to its control.
Genome Sequencing Provides Unprecedented Insight into Causes of Pneumococcal Disease
Technology will allow better surveillance of bacterial populations, understanding of vaccine effectiveness.
Statement of Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health.
BBSRC is Major Partner in Europe-wide Synthetic Biology Funding
BBSRC is contributing €3M as a major partner in a new call for research projects in Synthetic Biology.
Cobra Biologics and Vaccibody Sign Agreement to Manufacture DNA Vaccine
Companies announce agreement to manufacture Vaccibody’s lead DNA vaccine candidate against HPV-induced malignancies.
Cocaine Vaccine Passes Key Testing Hurdle
New anti-cocaine vaccine research shows drug can't reach the brain, human clinical trials on the horizon.
Vectura Establishes Strategic Partnership (Kinnovata) for New Respiratory Business in China
Kinnovata to commercialise products in fast growing Asian respiratory markets.
NIH Scientists Create New Tool for Identifying Powerful HIV Antibodies
It is believed that this latest advance could speed HIV vaccine research.
Bird Flu Expert Working on Vaccine that Protects Against Multiple Strains
As the bird flu outbreak in China worsens, a Purdue University expert is working on vaccines that offer broader protection against multiple strains of the virus.
GSK and Save the Children Partner to Help Africa
Currently, nearly 7 million children under five die every year from preventable diseases.
H7N9: A Novel Influenza Virus and it’s Control
Whilst the virus remains as one primarily circulating in birds, breaking this cycle of replication is the only effective response to its control.
Genome Sequencing Provides Unprecedented Insight into Causes of Pneumococcal Disease
Technology will allow better surveillance of bacterial populations, understanding of vaccine effectiveness.
TherapeuticsMD Elects Jules A. Musing to Board of Directors
TherapeuticsMD, Inc. announced the election of Jules A. Musing, a former senior executive at Johnson & Johnson, to its Board of Directors, effective immediately.
ImmunoCellular Therapeutics Announces Issuance of Key Patent for Cancer Vaccine Target
The US Patent and Trademark Office (USPTO) has issued a patent covering methods of use of interleukin 13-receptor alpha 2 protein (IL-13Ra2) in cancer immunotherapy.
Halo Pharma Announces Investment and Formal Collaboration with Altus
Halo Pharma has taken a minority ownership position in, and established a formal collaboration with, Altus Formulation Inc.
Navidea Biopharmaceuticals Signs Agreement with Nordion
Nordion to produce and distribute supplies of 123I-labeled drug product NAV5001 for late-phase clinical trials.
Bend Research Expands Analytical Sciences Capabilities
Bend Research Inc. announced that it has expanded its Good Manufacturing Practice (GMP) analytical capabilities and capacity for pharmaceutical development.
Agilent Technologies Introduces Verified Dissolution Components for Pharmaceutical Market
Agilent Technologies Inc. introduced a new series of verified dissolution components, including molded vessels as well as paddle and basket shafts.
FDA Accepts Biogen Idec’s Biologics License Application
ELOCTATE™ has potential to provide long-lasting protection and markedly reduce treatment burden for patients.
PMMI and ISPE Partner to Launch Pharma EXPO
New pharmaceutical processing and packaging event to co-locate with PACK EXPO International 2014.
Dyadic Welcomes New Chief Operating Officer
Danai Brooks will join the Company as Executive Vice President and Chief Operating Officer.
Aeras, Oxford University, Okairos: TB, HIV and Malaria Vaccine Research Gets Major Boost
$2.9 million grant to advance chimpanzee adenovirus platform.
TherapeuticsMD, Inc. announced the election of Jules A. Musing, a former senior executive at Johnson & Johnson, to its Board of Directors, effective immediately.
ImmunoCellular Therapeutics Announces Issuance of Key Patent for Cancer Vaccine Target
The US Patent and Trademark Office (USPTO) has issued a patent covering methods of use of interleukin 13-receptor alpha 2 protein (IL-13Ra2) in cancer immunotherapy.
Halo Pharma Announces Investment and Formal Collaboration with Altus
Halo Pharma has taken a minority ownership position in, and established a formal collaboration with, Altus Formulation Inc.
Navidea Biopharmaceuticals Signs Agreement with Nordion
Nordion to produce and distribute supplies of 123I-labeled drug product NAV5001 for late-phase clinical trials.
Bend Research Expands Analytical Sciences Capabilities
Bend Research Inc. announced that it has expanded its Good Manufacturing Practice (GMP) analytical capabilities and capacity for pharmaceutical development.
Agilent Technologies Introduces Verified Dissolution Components for Pharmaceutical Market
Agilent Technologies Inc. introduced a new series of verified dissolution components, including molded vessels as well as paddle and basket shafts.
FDA Accepts Biogen Idec’s Biologics License Application
ELOCTATE™ has potential to provide long-lasting protection and markedly reduce treatment burden for patients.
PMMI and ISPE Partner to Launch Pharma EXPO
New pharmaceutical processing and packaging event to co-locate with PACK EXPO International 2014.
Dyadic Welcomes New Chief Operating Officer
Danai Brooks will join the Company as Executive Vice President and Chief Operating Officer.
Aeras, Oxford University, Okairos: TB, HIV and Malaria Vaccine Research Gets Major Boost
$2.9 million grant to advance chimpanzee adenovirus platform.
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Acute Infective Endocarditis: Early Surgery versus Conventional Treatment
University of Otago, Christchurch, New Zealand
Infective endocarditis (IE) refers to thew inflammation of the inner layer of the heart, the endocardium, secondary to an infectious (most commonly bacterial) agent. It affects the left side of the heart more commonly than the right. IE has an estimated incidence of 1.4 to 6.2 per 10,000 persons in the developed countries, and is most commonly caused by Staphylococcus aureus, coaguase-negative staphylococcus, Viridans group streptococci and Straptococcus bovis.
First total synthesis of Combretastatin D-2 congeners named Isocorniculatolide A and 11-o-methylisocornicultolide
JNTU Hyderabad
As a part of our ongoing research in synthesizing the Biologically important Natural Products, here we are reporting First total synthesis of newly isolated isocorniculatolide A and 11-O-methyl corniculatolide A.
Automated Solutions for Cellular Screening and Characterization of Therapeutic Antibodies for Antibody-Dependent Cellular Cytotoxicity Utility
BioTek Instruments
Since the end of the 1990’s, the pharmaceutical industry has seen an increased interest in biologics, especially in the therapeutic areas of oncology and inflammation. Here we present the automation of two assays for the characterization and selection of potent antibody drug candidates. Both assays rely on HTRF® detection. The first assay quantifies the binding affinity of antibodies to their target antigen, on live cells.
Validation of an Automated Cell-Based Bioluminescent TNFa Blocker Bioassay
BioTek Instruments
TNFa blocker biopharmaceuticals represent an important and successful class of protein drugs used in the treatment of several autoimmune diseases. Bioassays are indispensible tools in biopharmaceutical drug development and commercialization that are used to quantify biological activity and stability of drugs or drug candidates. The automation of these assays can serve to create an accurate, robust process which can allow the researcher to perform other more important functions.
Improving Cell-Mediated Cytotoxicity Assessment through the Use of an Automated Luminescent ADCC Assay
BioTek Instruments
Assays that can assess the ability of a biosimilar to act in a manner similar to the original biologic have seen increased interest. This poster describes the use of a non-radioactive luminescent chemistry to simplify the assay process and provide improved data quality.
Antigen Determination in Autoimmune Hepatitis Type1
Institute of Liver and Biliary Sciences
Objectives of this project were to exploit the database in indian setting to determine nuclear antigens as target for antinuclear antibodies (ANA) in patients of autoimmune hapatitis (AIH) type1.
Biopharmaceuticals Hiding in the Woods
University of New Brunswick
Suggestions are provided of how efficient industrial bioprocessing can be accomplished, independently of highly expensive molecular biology approaches, in order to recover natural products of medicinal value from wild plant species.
A Mix-and-Read Cell-Based Assay for Antibody Screening Against Epidermal Growth Factor Receptor
TTP Labtech Ltd
The conventional antibody screening assay based on antibody-antigen binding has been enzyme-linked immunosorbent assay (ELISA). While tedious and consuming, ELISA has proved sufficient for the identification of antibodies directed against secreted antigens. However, cell surface antigens (e.g. GPCRs) provide challenges for ELISA due to the shortage of soluble antigens and high variability resulting from loss of cells during wash procedures.
Facing the challenges in bio-pharmaceutical production: newly developed polymer-based ion exchange chromatography media and their application to the purification for Immunoglobulin – from egg yolk
YMC
Much attention has been given to ion exchange (IEX) media as a means to improve productivity as a result of increasing demand for higher efficiency on the downstream process. Until recently, strain optimisation for high productivity and upstream purification were the bottlenecks for most bio-processes.
Development and NDA-Level Validation of a Real-Time PCR Procedure for Detection and Quantification of Residual E.coli DNA Contamination of Biopharmaceutical Products
Aptuit, Inc.
Escherichia coli (E. coli) has been commonly used for the production of biopharmaceuticals. Among the impurities that must be monitored in biopharmaceuticals is residual host-cell DNA (HCD). This study describes the development and subsequent NDA-level validation of a real time PCR procedure developed in response to a client’s need to improve the sensitivity of detection and quantification of residual E. coli HCD in their drug product.
University of Otago, Christchurch, New Zealand
Infective endocarditis (IE) refers to thew inflammation of the inner layer of the heart, the endocardium, secondary to an infectious (most commonly bacterial) agent. It affects the left side of the heart more commonly than the right. IE has an estimated incidence of 1.4 to 6.2 per 10,000 persons in the developed countries, and is most commonly caused by Staphylococcus aureus, coaguase-negative staphylococcus, Viridans group streptococci and Straptococcus bovis.
First total synthesis of Combretastatin D-2 congeners named Isocorniculatolide A and 11-o-methylisocornicultolide
JNTU Hyderabad
As a part of our ongoing research in synthesizing the Biologically important Natural Products, here we are reporting First total synthesis of newly isolated isocorniculatolide A and 11-O-methyl corniculatolide A.
Automated Solutions for Cellular Screening and Characterization of Therapeutic Antibodies for Antibody-Dependent Cellular Cytotoxicity Utility
BioTek Instruments
Since the end of the 1990’s, the pharmaceutical industry has seen an increased interest in biologics, especially in the therapeutic areas of oncology and inflammation. Here we present the automation of two assays for the characterization and selection of potent antibody drug candidates. Both assays rely on HTRF® detection. The first assay quantifies the binding affinity of antibodies to their target antigen, on live cells.
Validation of an Automated Cell-Based Bioluminescent TNFa Blocker Bioassay
BioTek Instruments
TNFa blocker biopharmaceuticals represent an important and successful class of protein drugs used in the treatment of several autoimmune diseases. Bioassays are indispensible tools in biopharmaceutical drug development and commercialization that are used to quantify biological activity and stability of drugs or drug candidates. The automation of these assays can serve to create an accurate, robust process which can allow the researcher to perform other more important functions.
Improving Cell-Mediated Cytotoxicity Assessment through the Use of an Automated Luminescent ADCC Assay
BioTek Instruments
Assays that can assess the ability of a biosimilar to act in a manner similar to the original biologic have seen increased interest. This poster describes the use of a non-radioactive luminescent chemistry to simplify the assay process and provide improved data quality.
Antigen Determination in Autoimmune Hepatitis Type1
Institute of Liver and Biliary Sciences
Objectives of this project were to exploit the database in indian setting to determine nuclear antigens as target for antinuclear antibodies (ANA) in patients of autoimmune hapatitis (AIH) type1.
Biopharmaceuticals Hiding in the Woods
University of New Brunswick
Suggestions are provided of how efficient industrial bioprocessing can be accomplished, independently of highly expensive molecular biology approaches, in order to recover natural products of medicinal value from wild plant species.
A Mix-and-Read Cell-Based Assay for Antibody Screening Against Epidermal Growth Factor Receptor
TTP Labtech Ltd
The conventional antibody screening assay based on antibody-antigen binding has been enzyme-linked immunosorbent assay (ELISA). While tedious and consuming, ELISA has proved sufficient for the identification of antibodies directed against secreted antigens. However, cell surface antigens (e.g. GPCRs) provide challenges for ELISA due to the shortage of soluble antigens and high variability resulting from loss of cells during wash procedures.
Facing the challenges in bio-pharmaceutical production: newly developed polymer-based ion exchange chromatography media and their application to the purification for Immunoglobulin – from egg yolk
YMC
Much attention has been given to ion exchange (IEX) media as a means to improve productivity as a result of increasing demand for higher efficiency on the downstream process. Until recently, strain optimisation for high productivity and upstream purification were the bottlenecks for most bio-processes.
Development and NDA-Level Validation of a Real-Time PCR Procedure for Detection and Quantification of Residual E.coli DNA Contamination of Biopharmaceutical Products
Aptuit, Inc.
Escherichia coli (E. coli) has been commonly used for the production of biopharmaceuticals. Among the impurities that must be monitored in biopharmaceuticals is residual host-cell DNA (HCD). This study describes the development and subsequent NDA-level validation of a real time PCR procedure developed in response to a client’s need to improve the sensitivity of detection and quantification of residual E. coli HCD in their drug product.
Direct Visualisation, Sizing and Counting of Aggregation in Proteins
NanoSight Ltd
Characterising the state of aggregation in proteins is of paramount importance when trying to understand biopharmaceutical product stability and efficacy. Product quality, both in terms of biological activity and immunogenicity can be highly influenced by the state of protein aggregation.
Direct Visualisation, Sizing & Counting of Viruses and Phages in Liquid Suspension
NanoSight Ltd
A new laser-based nanoparticle tracking analysis system is now available which allows nanoscale particles such as viruses and virus aggregates to be directly and individually visualised in liquids in real-time, from which high-resolution particle size distribution profiles can be obtained.
Automating Aqueous Compound Solubility Using the 96-Well Multiscreen® Solubility Filter Plate on a Hamilton Microlab® Star Workstation
Hamilton
Here we describe an automated method for determining drug solubility using Millipore’s MultiScreen Solubility filter plate on the Hamilton MICROLAB STAR workstation.
Contaminant bovine IgG assay
Molecular Devices
Fetal calf serum containing bovine IgG is commonly used in mammalian cell culture media for the production of recombinant pharmaceuticals. During the purification process of a recombinant pharmaceutical, bovine IgG may be copurified with the product, and may represent a biological hazard for clinical use. Therefore, it may be necessary to assay for contaminant bovine IgG in a final product originating from mammalian cells.
LanthaScreen TR-FRET Assay Performance with Thermo Scientific Varioskan Flash Spectral Scanning Multimode Reader
Thermo Fisher Scientific
LanthaScreen technology uses time-resolved fluorescence resonance energy transfer (TR-FRET) to study multiple target classes including protein kinases, nuclear hormone receptors, as well as proteases and ubiquitinated proteins.
Integrated Solutions for High-Throughput Bioprocessing Applications
Thermo Fisher Scientific
Advances in blood banking, industrial biotechnology, bio-production and pharmaceutical laboratories have driven the need to process multiple sample batches.
NanoSight Ltd
Characterising the state of aggregation in proteins is of paramount importance when trying to understand biopharmaceutical product stability and efficacy. Product quality, both in terms of biological activity and immunogenicity can be highly influenced by the state of protein aggregation.
Direct Visualisation, Sizing & Counting of Viruses and Phages in Liquid Suspension
NanoSight Ltd
A new laser-based nanoparticle tracking analysis system is now available which allows nanoscale particles such as viruses and virus aggregates to be directly and individually visualised in liquids in real-time, from which high-resolution particle size distribution profiles can be obtained.
Automating Aqueous Compound Solubility Using the 96-Well Multiscreen® Solubility Filter Plate on a Hamilton Microlab® Star Workstation
Hamilton
Here we describe an automated method for determining drug solubility using Millipore’s MultiScreen Solubility filter plate on the Hamilton MICROLAB STAR workstation.
Contaminant bovine IgG assay
Molecular Devices
Fetal calf serum containing bovine IgG is commonly used in mammalian cell culture media for the production of recombinant pharmaceuticals. During the purification process of a recombinant pharmaceutical, bovine IgG may be copurified with the product, and may represent a biological hazard for clinical use. Therefore, it may be necessary to assay for contaminant bovine IgG in a final product originating from mammalian cells.
LanthaScreen TR-FRET Assay Performance with Thermo Scientific Varioskan Flash Spectral Scanning Multimode Reader
Thermo Fisher Scientific
LanthaScreen technology uses time-resolved fluorescence resonance energy transfer (TR-FRET) to study multiple target classes including protein kinases, nuclear hormone receptors, as well as proteases and ubiquitinated proteins.
Integrated Solutions for High-Throughput Bioprocessing Applications
Thermo Fisher Scientific
Advances in blood banking, industrial biotechnology, bio-production and pharmaceutical laboratories have driven the need to process multiple sample batches.
