BioPharm International Webcasts



Biocompatibility Testing of Combination Devices – New Regulatory Guidance

Thursday, November 3, 2016 8 am PDT | 11 am EDT | 3 pm GMT | 4 pm CET

Join us for this informative webinar to learn how to implement an efficient testing program for assessing the biocompatibility of your combination product and learn about the FDA’s new guidance document on ISO 10993-1.

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Sponsor: Eurofins Lancaster Laboratories and Eurofins Medical Device Testing

New Techniques to Characterize mAbs and ADCs
Tuesday, November 29, 2016 | 11am EST | 8am PST | 4pm GMT | 5pm CET

Learn about HPLC characterization of monoclonal antibodies (mAbs)and antibody-drug conjugates (ADCs) using the newest chemistries and techniques. Gain insight into the heterogenity of mAbs and ADCs using HPLC and LC/MS
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Sponsor: Thermo Fisher Scientific

A Single Intermediate Purification Step to Improve Monoclonal Antibody Purity: Impurity Removal with a Strong Cation Exchange Resin
Thursday, Dec. 01, 2016, 2:00 PM EDT | 1:00pm CDT | 11:00am PDT

Join Tosoh Bioscience for a discussion on a single polishing step for impurity removal during the process of monoclonal antibody purification.

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Sponsor: Tosoh Bioscience


Oligonucleotide Characterization and Quantitative Bioanalysis by LC–MS
Available until Sept. 29, 2016

Learn how a polymer-based reversed phase column can be used to analyze challenging oligonucleotide samples using LC–MS and how quantitative bioanalysis of oligonucleotides can be performed using LC–MS/MS or LC–HRAM. Experts explain how the polymer resin allows the use of high pH and/or high-temperature conditions, which often results in higher resolution separation of challenging oligonucleotide samples.

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Sponsored by Thermo Fisher Scientific 

Bridging the Gap Between Analytical and Process Protein A Chromatograph
Available until July 27, 2017

Join Tosoh Bioscience for a discussion on the link between protein A resin for manufacturing and analytical chromatography.

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Sponsored by Tosoh Bioscience

Functional Comparability Studies for Biosimilar Development 
Available until June 21, 2017

Functional comparability studies provide a basis for assessing the biosimilarity of proposed follow-on biologics to innovator products.

Join this webcast to review regulatory guidelines, required studies, and qualification of assays used in these studies.

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Sponsored by SGS 

Compliance is Key: Solutions to Decrease the Likelihood of Receiving a Form 483
Available until June 23, 2017

What drives a pharmaceutical company to scrutinize an instrument manufacturer and every detail of the instrument during instrument qualification? The answer is simple, compliance. Every company that produces pharmaceutical products must guarantee a consistent quality product that meets regulated specifications for the entire product life cycle, from production to consumption. What happens when that compliance falls short? A review of inspection citations from 2015 can help you learn from the mistakes of others. Learn about solutions to decrease the likelihood of receiving an FDA Form 483.

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Sponsored by Anton Paar

Effective Extractables and Leachables Evaluation Programs for Single-Use Systems

Available Until May 31, 2017

As single-use systems gain wider use in biopharmaceutical manufacturing, drug owners must understand the risk of potential contaminants from plastics interacting with the drug. Establishing clearly defined standards for acceptable testing protocols and has proven difficult. In this webcast learn about available guidance documents, a risk-based materials qualification process for extractables and leachables studies; and the value of standardized and custom testing protocols.

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Sponsor: SGS Life Science Services

Bio/Pharma in China: New Initiatives, New Opportunities
Available Until May 18, 2017 

The China Food and Drug Administration is to moving upgrade the country’s bio/pharmaceutical industry including new manufacturing operations that meet Western standards to meet the medicinal needs of the nation’s population. In this webcast, experts offer insight into opportunities for Western bio/pharmaceutical companies in China, and address lingering and unexpected questions about doing business there.

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Sponsor: CPhI China


Drug Stability Testing from Development to Shipping
Available until April 27, 2017

In this educational webcast, learn about regulatory expectations and practical approaches to stability testing of drug substances and drug products for clinical trials, packaging, storage, and transportation.

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Sponsor: SGS Life Science Services

How will you respond when the FDA asks: Are you effectively monitoring your subcontractors?
Available Until March 23, 2017 

Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.

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Sponsor: Eurofins Lancaster Labs

Best Practices for Effective Product Transfer
Available until Jan. 20, 2017

Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.

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Sponsor: Rottendorf Pharma

Automated De Novo Identification and Profiling of Disulfide Bonds in Biotherapeutics Including Analysis of Disulfide Bond Scrambling in Monoclonal Antibodies
Available until Nov. 3, 2016

Understanding the disulfide bonds (DSBs) in biotherapeutics is required for verifying its structure and evaluating quality to determine if a monoclonal antibody has scrambled DSBs.  In this webinar, experts will demonstrate the latest hardware and software available to automatically detect, analyze, and evaluate DSBs within monoclonal antibodies.

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Sponsor: Bruker

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