BioPharm International Webcasts

 

LIVE WEBCASTS

Practical Implementation of the New Elemental Impurities Guidelines
US: Tuesday, May 5, 2015, 11 am EDT   |  Europe: Tuesday May 12, 2015, 15:00 CEST

The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. Companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the requirements of elemental impurities guidelines, practical recommendations to address implementation challenges, and key considerations for analytical testing programs. 

Register free: www.pharmtech.com/pt/impurities
Sponsored by SGS Life Science Services


Practical Guidance for Successful Mammalian Cell Banking & Cell Line Characterization
Thursday, May 14, 2015, 11 am EDT  |  8 am PDT  |  16:00 BST  |  17:00 CEST


Join this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.

Register Free
Sponsored by Eurofins Lancaster Laboratories


Insights Into Recent Developments in Protein A Chromatography
Wednesday, May 20, 2015 at 3 times: Beijing 2:00 pm CST  |  Stockholm 11:00 am CEST  |  New York 1:00 pm EDT

In this webcast Jonathan Royce will provide a brief background to the developments that have been made to improve capacity, cleanabilty and the overall process economy of MAb purification. Ligand, base matrix (bead) and process designs will be discussed and Jonathan will provide insights into how these are optimized by suppliers and users to meet specific purification challenges and to reduce the overall cost of manufacturing monoclonal antibodies

Register free: www.biopharminternational.com/bp/proteina 
Sponsored by GE Healthcare


The Importance of Data Integrity In a GXP Regulated Laboratory 
Wednesday, May 27, 2015 at 11AM ET

With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.

Register free: www.pharmtech.com/pt/data 

Sponsored by Mettler Toledo

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Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Fragments

Wednesday, June 17, 2015, 2 pm EDT  

|  2 pm EDT  

|  11 am PDT

Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.

Register Free
Sponsored by Tosoh Bioscience LLC


ON-DEMAND WEBCASTS

Tuning Out Noise with HRAM Survivor-SIM
Available unti April 22, 2016

Due to observed collision induced dissociation (CID) fragmentation inefficiency, developing sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) assays for CID-resistant compounds is especially challenging. An alternative methodology that preserves the intact analyte ion for quantification by selectively filtering ions while reducing chemical noise is presented.

Register Free at www.biopharminternational.com/bio/HRAM
Sponsored Thermo Fisher Scientific


Implications of Cell Culture Conditions on Biologic Product Quality
Available until March 11, 2016

Understand factors that affect cell line quality from process development through production, including regulatory considerations, factors for optimized bioreactor performance, and glycan analysis methods.

Register free: www.biopharminternational.com/efficacy
Sponsored by SGS Life Science Services


Development Strategies for High-performing Perfusion Media
Available until March 24, 2016

Integrated continuous processing, comprising production in a high-cell density perfusion culture coupled to a continuous capture step, has been suggested as a universal biomanufacturing platform.Learn about a structured approach to develop a perfusion medium from commercially available medium and feeds, which resulted in a final process with a cell-specific perfusion rate that was a 75% decrease compared with the starting process conditions.

Register free: www.biopharminternational.com/bp/perfusion
Sponsored by GE Healthcare


The Future of Continuous Downstream Processing
Available until Dec. 3, 2015

Where  is continuous downstream processing heading?  Join the discussion with Biogen Idec and GE Healthcare Life Science.

Register free: www.biopharminternational.com/continuousbioprocessing

Sponsored by GE Healthcare


Developing a Comprehensive Tool Kit for Microbial Identification
Available until Nov. 18, 2015
Learn about the application of various microbial identification methods, strain-typing techniques, microbial classifications, and the benefits of a comprehensive reference database. Attend this in depth presentation by Chris Gilmer, Sr. Microbiologist with Eurofins Lancaster Laboratories and Arnaud Carlotti, President, Eurofins IDmyk.

Register free www.pharmtech.com/Identification
Sponsored by Eurofins Lancaster Laboratories


New Innovations in UHPLC and LCMS Workflows for the Comprehensive Characterization of Monoclonal Antibodies (mAbs) and Antibody Drug Conjugates (ADCs)
Available until Nov. 13, 2015

Would you like to reduce method development time for mAb and ADC characterization from weeks to minutes and establish finalized methods that are more robust than previous methods? This webinar will describe new innovations and workflows for mAb characterization with advice on simplified method development and sample preparation.

Register free www.biopharminternational.com/Innovations
Sponsored by Thermo Fisher Scientific


Adding Mass Detection to Routine Peptide-Level Biotherapeutic Analysis
Available until Nov. 11, 2015

When peptide mass information is obtained from a simple mass detector, rather than a mass spectrometer used in full protein characterization, mass data becomes more easy and affordable to include as part of routine LC studies. This enables an analyst to rapidly confirm the expected mass of a synthetic peptide, track individual peptides during peptide mapping method development, build simple quantitative assays for measuring the extent of peptide modification, and rapidly troubleshoot unexpected LC/UV results by confirming peptide identity and the absence of coeluting species in a UV peak. In this webinar, we will review the useful insights available for peptide data that has been generated using Waters Empower 3 Software with an ACQUITY UPLC H-Class System configured with a TUV optical detector and the ACQUITY QDa Mass Detector.

Register free www.biopharminternational.com/detection
Sponsored by Waters


The Benefits of High Performing Chromatography Resins; Including POROS® XQ, A New Strong Anion Exchange
Available until Oct. 29, 2015

Learn how high capacity, high resolution and salt tolerant ion-exchange (IEX) resins can help revolutionize your approach to bioprocess chromatography. An expert will demonstrate the benefits of the newest AEX resin to downstream purification processes, including increased process flexibility and productivity, and improved cost of goods.

Register free at www.pharmtech.com/POROSXQ
Sponsored by Life Tech


Preparing for the New Elemental Impurities Guidelines
Available until Oct. 14, 2015

With the long anticipated revised guidelines for elemental impurities on the horizon, bio/pharmaceutical companies should initiate plans to transition to these new guidelines. In this webcast, experts (API, excipients and analytical testing) will discuss risk assessment, proposed test methods, and sample preparation techniques.

Register free at www.pharmtech.com/elemental
Sponsored by SGS Life Science Services


Chromatographic Removal of Aggregates in Downstream Purification of Monoclonal
Available until Oct. 8, 2015

The past 15 to 20 years have seen advances in biotechnology that have propelled monoclonal antibodies (mAbs) as the top-selling class of therapeutic drugs. With the increased commercial utilization of these molecules, it is imperative that chromatographers have access to the tools necessary to develop purification processes that deliver safe, pure, and effective drug products. Aggregate removal is one of the most important aspects in mAb purification. Removing aggregates, especially soluble ones, is highly challenging because of their close physical and/or chemical similarity to the target of interest.

Register free at www.biopharminternational.com/Antibodies
Sponsored by TOSOH BIOSCIENCE


Analytical Separation of Antibody Drug Conjugates (ADCs) and Monoclonal Antibodies (mAbs) Various Chromatographic Modes?
Available until Sept. 30, 2015

Antibody Drug Conjugates (ADCs) are more complex and heterogeneous than their corresponding unconjugated base antibody. Different chromatographic modes can be selected for analytical scale purification, based on the specificityof the individual ADC, the nature of the linker, the attachment sites, and more. With the advancement of HPLC analytical column chromatography, the separation of complex peptide mixtures derived from protease digestions of monoclonal antibodies (mAbs) and ADCs are possible.

Register free at www.biopharminternational.com/ADCs
Sponsored by TOSOH BIOSCIENCE


Fundamentals of Design of Experiments (DoE) in Protein Production and Purification

Available until Sept. 30, 2015
Whether it is for bioprocessing applications or research labs, developing and optimizing your protein production and purification process requires a lot of experiments. As the number of experiments increases, so does the cost.

Register free at www.biopharminternational.com/DoE
Sponsored by GE Healthcare


Utilizing PepFinder Software for Interrogation of LC-MS Peptide Map Data of Biotherapeutics?
Available until Sept. 17, 2015

The availability of commercial LC?MS software tools for full characterization of biotherapeutics has lagged behind the technological advances of MS instrumentation. Significant effort has been put into software tools to identify large mixtures of proteins in proteomics-based research. However, commercial software that focuses specifically on deep characterization of a single protein has been lacking. While proteomics software tools can be used to identify biotherapeutics, the majority of these tools do not have the ability to look for multiple and unexpected modifications, which are an important part of characterizing biotherapeutic drug products.

Register free at www.biopharminternational.com/Utilizing
Sponsored by Thermo Fisher Scientific


Accelerating Vaccine Development: Regulatory, Biosafety, and Clinical Strategies
Available until Sept. 9, 2015

The drive to bring efficacious, more cost-effective vaccines to market is challenging vaccine makers to innovate throughout the development continuum. This webcast will provide companies developing seasonal and pandemic influenza vaccines, as well as universal vaccines, with vital regulatory, biosafety, and clinical testing strategies to accelerate development.

Register free at www.biopharminternational.com/vaccinedev
Sponsored by SGS Life Science Services


Glycan Profiling and Differential Analysis to Elucidate Functional Differences in Therapeutic Antibodies
Available until July 31, 2015

In this free webcast, experts from Agilent and Gilead Science will discuss the challenges of characterization of glycan profiles throughout various phases of therapeutic mAbs development. Audience members will learn about rapid glycopeptide and glycan analysis of monoclonal antibodies using LC, LC/MS and HILIC, and a microfluidic-based HPLC-Chip coupled to an Agilent Accurate-Mass Q-TOF LC/MS. The discussion will include differential analysis using MassHunter Molecular Feature Extractor and other software tools to elucidate functional differences in the studied antibodies.

Register free at www.biopharminternational.com/analysis
Sponsored by Agilent Technologies


Fast, Robust LC and LCMS Workflows for the Comprehensive Characterization of Bio-Therapeutic Proteins
Available until June 3, 2015

Would you like to reduce method development time for mAb characterization from weeks to minutes? Have finalized methods that are more robust than previous methods? The webinar will describe new technology and workflows for mAb characterization with advice on simplified method development.

Register free at www.biopharminternational.com/fast
Sponsored by Thermo Fisher Scientific


Delivering Biologics with a Difference
Available until June 5, 2015

As the biologics market continues to grow with additional launches, expanding indications, and approvals of biosimilars, the delivery platform will play a more critical role in product differentiation. Join us for this webinar to explore the advantages, challenges, case studies and science behind delivering biologics with a difference.

Register free at www.pharmtech.com/difference
Sponsored by Baxter BioPharma Solutions


MAb manufacturing: Where are we headed, cost or capabilities?
Available until May 27, 2015

MAb manufacturing, where are we heading? Join the discussion with Gunter Jagschies of GE Healthcare Life Sciences.

Register free at www.biopharminternational.com/MAb
Sponsored by GE Healthcare


Effective Viral Contamination Testing Programs for Biologics Product Manufacturing
Available until May 20, 2015

Biopharmaceutical manufacturers need comprehensive virus testing programs to ensure product safety throughout various manufacturing stages. Learn how to establish or improve practices for effective virus testing programs and review test methods for virus detection and quantitation throughout the biopharmaceutical manufacturing process.

Register free at www.biopharminternational.com/virustesting
Sponsored by SGS Life Science Services


Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production
Available until April 22, 2015

Contamination poses a threat to process and product integrity, as well as patient safety. A comprehensive environmental monitoring program can ensure that manufacturing areas, cleanrooms, production equipment, and water and gas utilities are free of viable and non-viable contamination and meet regulatory requirements. In this webcast, learn about pertinent regulatory and quality standards, as well as best practices for establishing and maintaining an effective environmental monitoring program. Review measures for testing pharmaceutical water systems according to U.S. Pharmacopeial Convention (USP) water monograph as well as procedures to evaluate the purity of production gases.

Register free at www.pharmtech.com/emp
Sponsored by SGS Life Science Services


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