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EVENTS

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Industrial Microbiology Meets the Microbiome
INDUSTRIAL MICROBIOLOGY MEETS THE MICROBIOME
November 08-10, 2020
The goal of the meeting is to bring together academics, industrial scientists, technology providers and regulators in studying and manipulating the microbiome in industrial settings such as agriculture, household care, built environment, personal care, animal health, and nutrition. Recent results of...

FT Global Pharmaceutical and Biotechnology Conference 2020
FT GLOBAL PHARMACEUTICAL AND BIOTECHNOLOGY CONFERENCE 2020
November 09-10, 2020
The global pharma industry is at a turning point in its transformation. After years of research, the field of advanced cell and gene therapies is achieving new landmarks, and the reality of curative therapies is here. The focus on molecular targets is opening up new possibilities for research, with ...

SPOTLIGHT

Multi-attribute method (MAM) is usually based on a bottom-up approach, which relies on the enzymatic digestion of the protein into peptides prior to mass spectrometry (MS) analysis. Unfortunately, this processing can result in the loss of information about the whole molecule, such as the drug distri

OCT 26, 2020
NEXT GENERATION BIOPROCESS FACILITY DESIGN – A CASE STUDY FROM SAMSUNG BIOLOGICS
A case study be presented describing initiatives and bioprocessing approaches to maximize capacity utilization within a new large scale (12x 15kL) drug substance biologics manufacturing facility at Samsung Biologics. Facility design, manufacturing and validation strategies utilizing two harvest and ...
OCT 27, 2020
ADVANCES IN AAV VECTORS AND GENE THERAPY
Since the first proof-of-concept human application in the early ’90s, the field of gene therapy has overcome major setbacks and entered an exciting stage of clinical translation and transformation. Much of the credit goes to the development of new vector platforms, in particular recombinant ad...
OCT 28, 2020
THE GREAT CONVERGENCE: HOW BIOLOGY AND ENGINEERING UNITE TO RESHAPE OUR WORLD
A century ago, innovations in physics came together with engineering to produce an astonishing array of new technologies: radios, telephones, televisions, planes, radar, nuclear power, computers, GPS systems, the Internet, and more. These technologies so reshaped our world that we now can’t co...
OCT 28, 2020
ENSURING SAFETY AND EFFICACY OF BIOTHERAPEUTICS THROUGH IN-DEPTH LC-MS SEQUENCE VARIANT ANALYSIS
In this webinar, we will show you how to find and confirm sequence variants more easily using the right mass spectrometry tools. Sequence variants are unintended amino acid substitutions that occur during the production of biotherapeutics. They are considered impurities in drug substances and may af...
OCT 29, 2020
INNOVATIVE TECHNOLOGY FOR INSIGHTS INTO RECEPTOR TYROSINE KINASE BIOLOGY
Receptor Tyrosine Kinases (RTKs) regulate many critical processes such as cell growth, differentiation, and survival through the recruitment of intracellular signaling molecules. Dysregulated RTK activity can affect many cellular functions, often culminating in cancer, making RTKs prime targets for ...
OCT 29, 2020
ADVANTAGE OF ANTIBODY-BASED SELECTIVITY IN THE PURIFICATION OF NEXT-GENERATION BIOLOGICS
Advances in biotherapeutics are generating an increasing range of complex molecules that present unique and often complex purification challenges. Affinity chromatography can serve as a platform solution for the purification of these challenging molecule modalities. An effective affinity resin can h...
NOV 03, 2020
RAPID DEVELOPMENT OF MULTITAGGED CELL LINES FOR DRUG DISCOVERY
The pharmaceutical industry relies heavily on the use of in-vitro mammalian cell culture systems for drug discovery. Through in-vitro cell studies, targeted effects such as efficacy and toxicity can be tested before expensive animal studies, to select compounds with a higher probability of success. ...
NOV 03, 2020
ANALYTICAL CHALLENGES FOR GENE THERAPY
One of the biggest challenges for AAV gene therapy products is establishing an appropriate analytical strategy to support product manufacture, release, stability, comparability and characterization at different stages of development. This presentation will highlight some of the existing analytical c...
NOV 03, 2020
INTACT AND SUBUNIT MAM ASSAYS ACCELERATE THE DEVELOPMENT OF ANTIBODY-DRUG CONJUGATES
Multi-attribute method (MAM) is usually based on a bottom-up approach, which relies on the enzymatic digestion of the protein into peptides prior to mass spectrometry (MS) analysis. Unfortunately, this processing can result in the loss of information about the whole molecule, such as the drug distri...
NOV 04, 2020
BIOMANUFACTURING ASSUMES CENTRAL ROLE IN CELL AND GENE THERAPIES
Cell and gene therapy products represent some of the most exciting new drugs that biopharmaceutical companies are looking to bring to market. Based on recent clinical successes, an increasing number of cell and gene therapies are currently in clinical development. However, despite the tremendous amo...
NOV 10, 2020
INNOVATION IN BIOMANUFACTURING PLANTS
Biopharmaceutical plants will look different in the future. Agility and flexibility for rapidly changing product portfolios, single-use technologies, continuous manufacturing, small batch manufacturing, personalised medicine manufacturing will not only change the face of a plant but will also requir...
NOV 11, 2020
SMART MACHINE LEARNING SOLUTION TO MASTER INDUSTRY 4.0 IN BIOPHARMA
In the biopharmaceutical industry the utilization of miniaturized and parallelized high throughput techniques, continuous bioprocessing and continuous data acquisition as well as the utilization of data- and knowledge-driven tools for process analysis, forecasting, monitoring, control and digital tw...
ADDRESSING THE CHALLENGES IN MAINTAINING AND ANALYZING BIOTHERAPEUTIC GLYCOSYLATION
As the market for biopharmaceuticals continues to grow, manufacturers are increasingly challenged to improve their process efficiency while maintaining in vivo safety and efficacy profiles. Foremost of those challenges is minimization of batch-to-batch variability in product profile. Heterogeneous g...
FDA REGULATION OF HUMAN CELLS, TISSUES AND CELLULAR AND TISSUE-BASED PRODUCTS
Companies manufacturing products derived from human cells and tissues for autologous implantation, transplantation, infusion or transfer of human cells and tissues for therapeutic purposes are allowed to market their products without a formal marketing approval under a BLA provided they meet certain...
USING MICROPATTERNED CO-CULTURES TO MODEL HUMAN-SPECIFIC DRUG METABOLISM, DISPOSITION AND DRUG-DRUG INTERACTIONS
Webinar was presented on 10 March, 2016 by Dr. Salman Khetani, Associate Professor, Department of Bioengineering, University of Illinois at Chicago, USAIn this webinar, Dr Salman described how micropatterned co-cultures (MPCCs) containing cryopreserved hepatocytes in industry-standard multi-well pla...
ENGINEERING MICROPATTERNED CO-CULTURES FOR DRUG DEVELOPMENT
Due to significant differences across species in liver pathways, models of the human liver are used to screen for potential efficacy and/or toxicity of candidate compounds. Such models serve to complement and reduce the number of animals used in studies required by regulatory agencies. However, once...
THE UTILITY OF MICROSCALE HUMAN LIVER CO-CULTURES FOR INVESTIGATING DRUG TOXICITY OUTCOMES
Drug-induced liver injury (DILI) remains a leading cause of acute liver failures and the attrition of pharmaceuticals in both preclinical and clinical settings. Due to species-specific differences in drug metabolism pathways, animal models do not always fully predict human DILI. Thus, there is a nee...
COMBINING TRANSPORTER DATA WITH QUANTITATIVE SYSTEMS TOXICOLOGY MODELING (DILISYM) TO IMPACT DECISIONS IN DRUG DEVELOPMENT
A quantitative systems toxicology (QST) model of drug-induced liver injury (DILI) has been developed through the DILI-sim Initiative over the past 7 years to assist in the safety characterization of compounds in clinical development. The emerging platform, DILIsym®, is capable of predicting and ...
THE POTENTIAL OF ENGINEERED HUMAN LIVER CO-CULTURES IN PHENOTYPIC DRUG DISCOVERY FOR LIVER DISEASES
The diverse functions of the liver (i.e. albumin synthesis, glucose and fatty acid metabolism, drug metabolism) can be severely compromised by several diseases. In particular, drug-induced liver injury is a leading cause of drug attrition; hepatitis B virus chronically infects the livers of ~400 mil...
WIPR AND BSKB PRESENT: OBVIOUSNESS IN PTAB TRIALS FOR CHEM/PHARMA/BIO PATENTS.
Challenging patents involving unpredictable technologies for obviousness is particularly difficult due to the well-established factor of “reasonable expectation of success” and the related KSR factor of “limited number of predictable solutions”. This webinar, presented by att...
THE TRUTH ABOUT DELIVERING CLINICAL RESEARCH IN THE UK?
Over the last seven years the research landscape in the UK has improved dramatically allowing the UK to make great strides in delivering research for the Life Sciences industry. So whether you are a Pharmaceutical Company, Contract Research Organisation, Biotech, Med Tech or Diagnostic company we ca...
DEVELOPING MEDICAL EDUCATION THAT ADVANCES PATIENT OUTCOMES.
As pressure mounts on the pharmaceutical industry to demonstrate a tangible and positive impact on patients’ lives, understanding barriers to specific clinician behaviours is key to achieving measurable change in clinical practice and advancing patient outcomes.
ESTABLISHING FERTILITY BIOMARKERS
The adult mammalian ovary contains thousands of oocytes, yet only very few will be ovulated and able to support embryonic development until birth. Why are so many oocytes eliminated? What makes an oocyte of good or bad quality? With approximately 15% of couples of reproductive age needing assisted r...
MONITORING PRODUCT AND PROCESS ATTRIBUTES IN BIOPHARMACEUTICAL DEVELOPMENT AND QC
Across biopharmaceutical development, LC-MS has been a foundational technology for the discovery and characterization of biotherapeutic attributes—including post-translational modifications such as glycosylation, oxidation, and deamidation, as well as process impurities such as host cell prote...