BioPharm International Webcasts



Bridging the Gap Between Analytical and Process Protein A Chromatograph
Wednesday, July 27, 2016 at 2:00-3:00 pm EDT

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

Register for Free
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.

Register for Free
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.

Register for Free
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.

Register for free
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.

Register for free 
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.

Register for free
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.

Register for free
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.

Register for free
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.

Register for free
Sponsor: Bruker

Monoclonal Antibody Purification by Protein A Affinity and Hydroxyapatite Mixed Mode: Multi-Column Continuous Chromatography
Available until Oct. 7, 2016

Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.

Register for free
Sponsor: Tosoh Bioscience

Built for Biopharma: State-of-the-Art UHPLC for Characterizing Biotherapeutics

Available until Sept. 24 2016 

Gain new insights on the development of liquid chromatography methods, which are optimized to meet the requirements of modern biotherapeutics characterization laboratories. Emphasis will be given in guiding the selection of the proper column characteristics and instrument settings with respect to biotherapeutic characterization.

Register for free 

Sponsored by Thermo Fisher Scientific

Controlling Contamination in Biopharmaceutical Manufacturing
Available until Sept. 15, 2016

In this webcast, experts will review the sources of contamination, regulations and guidance documents on the control of potential contaminants in raw materials, and best practices to guard against the introduction of contaminants in the manufacturing process. The challenges of detecting contaminants, including mycoplasma, assay development, and testing practices will be discussed.

Register for free

Sponsored by SGS Life Science Services

Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins
Available until July 30, 2016


The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.

Register for free

Sponsored by Patheon

Strategies to Accelerate Early Phase Clinical Trials
Available until June 23, 2016
Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.

Register for Free
Sponsored by SGS

Trends in Quality Agreements & Communications: A CMO Perspective
Available until June 23, 2016
This webinar, led by Milton Boyer, senior vice-president of drug product manufacturing at AMRI, will review and challenge the changing paradigms in the CMO­/drug sponsor relationship. It is clear that both CMOs and drug sponsors are being held responsible for the actions of the other. Responsibilities once thought to be clearly defined are changing, with new guidance and expectations revealed in 483s and FDA warning letters.


Register for Free
Sponsored by AMRI

Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Fragments
Available until June 17, 2016

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

Register for Free
Sponsored by Tosoh Bioscience LLC


Sample Preparation Technologies for Improved Peptide Quantitation Workflow
Available until June 16, 2016

Peptide quantitative analysis requires workflows that deliver high levels of data quality while balancing the needs of sample throughput and regulatory compliance. Learn how advances in sample preparation can enable greater speed, reproducibility, and improved data quality.

Register for Free 
Sponsored by Thermo Fisher Scientific

The Importance of Data Integrity In a GXP Regulated Laboratory
Available until May 27, 2016

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 for Free
Sponsored by Mettler Toledo

Insights Into Recent Developments in Protein A Chromatography
Available until May 20, 2016

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
Sponsored by GE Healthcare

Practical Guidance for Successful Mammalian Cell Banking & Cell Line Characterization
Available until May 14, 2016

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

Practical Implementation of the New Elemental Impurities Guidelines
Available until May 5, 2016

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 for Free
Sponsored by SGS Life Science Services

Tuning Out Noise with HRAM Survivor-SIM
Available until 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 for Free
Sponsored Thermo Fisher Scientific

For more multimedia content from Biopharm International, including podcasts and videos, click here.



lorem ipsum