A Rationally Integrated Approach

Most biopharmaceutical production platforms are based on fed-batch cell culture protocols, which can support high volumetric productivity while maintaining low operational complexity (1). The industry is interested in developing or refining high-titer cell culture processes to meet increasing market demands and reduce manufacturing costs (2). Although advancements in cell engineering have enabled development of high-performing recombinant cell lines (3–6), improvements in cell culture media and process parameter settings are required to realize the maximum production potentials of those cells (7–8).

In a fed-batch process, a basal medium supports initial growth and production, and a feed medium prevents depletion of nutrients and sustains the production phase (9). Those media can contain different assortments of nutrients to accommodate the distinct metabolic requirements during different production phases. Process parameter settings — including feeding strategy and control parameters — define the chemical and physical environments suitable for cell growth and protein production. Optimization of a fed-batch process can be achieved by development efforts addressing one or more of three major elements: basal medium, feed medium, and process settings. Given the large sets of variables in these systems, establishing a cost- and time-efficient approach for process optimization is desired but challenging.” BioProcess International by Zhou Jiang, Kurt Droms, Zhaohui Geng, Susan Casnocha, Zhihua Xiao, Steve Gorfien, and Scott J. Jacobia

 
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Post-Conference Workshop at BioProduction

Workshop W: Implementation of QbD for Biopharmaceuticals – the Pain and the Gain
This full-day workshop concerns the theory and practice for implementation of Quality by Design (QbD) systems for biopharmaceuticals. The emphasis will be on QbD to support
drug design and manufacturing as well as biopharmaceutical comparability.

Workshop X: Comparability: Developing Strategies for Scaling Up, Tech Transfer and Other Process Changes
The objective of this workshop is to provide principles for assessing the comparability of biological products, to discuss approaches to demonstrate comparability and to review regulatory requirements. Topics to be covered include: ICH Q5E, regulatory input, demonstrating comparability at a CMC level, case studies and post marketing authorisation manufacturing process changes.

Workshop Y: Understanding Aggregation and Devising Prevention Strategies
Attend this full-day workshop to gain a critical overview of the available techniques for detection of aggregation and how these methods can be applied across bioprocessing.
Delegates will hear about strategies for combining analytical methods to ensure detection across a range of particle sizes. There will be a chance to review what is understood about the triggers of aggregation and the progress made in engineering products to reduce the risk of aggregation.

Workshop Z: Expression Systems for Antibodies and Their Fragments
This workshop offers an overview of antibody-related products and of the various expression systems available for their manufacturing focusing on the newest technologies and methods for expressing antibodies related products with improved quality and lower cost.

For more information visit the website or download the brochure.

Louisa Maitland
Bioproduction Researcher Manager
Informa Life sciences

Pre-Conference Workshops at BioProduction

Site Visit R: TU Berlin and Medical Biotechnology
The Bioprocess Engineering department, devotes its research activities to the area of biocatalysis, specifically to the design of new engineered biocatalysts and to the methods of their development. Aside from molecular biology laboratories the visitors will see the bioprocess pilot plant, the high throughput laboratory together with a short presentation of the key projects of the chair and the Institute of Biotechnology. Please join us in the afternoon following the workshops to visit these interesting laboratories.

Workshop S: Practical Technology Transfer for Biopharmaceuticals
Technology Transfer can easily make the difference between a successful or failed project and it is therefore essential in getting it right the first time.  In this workshop we will look at how to derive, implement and manage a successful technology transfer project; lifting technology transfer off the page and putting it into practical context that can be readily applied in the field.  The One day interactive workshop will look at the principles and practices of technology transfer, how to assemble the nuts and bolts, case study scenarios and problem based team challenges.

Workshop T: Analytical Tools Helping to Develop and Solve Issues with Formulation
One of the troubling and challenging tasks in the development of protein pharmaceuticals is to deal with their physical and chemical instabilities. Materials in contact by our protein pharmaceuticals during a manufacturing process are numerous. The phenomena of adsorption of our drug substance on the surface of  container are more and more suspected. They can have a huge impact on either the accuracy of the dose of protein administered or the structure of the protein (for example the most common physical instability is aggregation and apparition of particles).  Proper and adequate analytical methods have to be used to ensure successful development of quality protein products.

Workshop U: Biopharmaceutical Fundamentals
This workshop introduces the audience into the world of biopharmaceutical, the practical outcome of the 30+ year biotechnology revolution, by describing the critical scientific, safety, efficacy, manufacturing, clinical, regulatory, marketing and legal issues influencing the discovery, development, and commercialisation of these products.

Workshop V: Mixed Mode Chromatography Strategies for Biomolecule Production
A majority of monoclonal antibodies are purified using affinity or protein A. For each non-antibody therapeutic in today’s pipeline the lack of an affinity capture increases the burden on every step of the downstream process to achieve final product purity. Mixed mode media have a significant role in polishing for monoclonal applications, and are now being leveraged into capture, intermediate and polishing steps for new protein therapeutics.

For more information visit the website or download the brochure.

Louisa Maitland
Bioproduction Researcher Manager
Informa Life sciences

Immunogenicity Concerns and Extensions to other classes of Drugs

 ”Small-molecule treatments are invaluable in providing symptomatic benefits for an array of illnesses. However, many serious conditions — ranging from cancer to autoimmune disorders — respond better to more sophisticated complex drugs such as therapeutic biologics and nonbiologic complex drugs (NBCDs). The latter are medicinal, nonbiological products in which the active substance is not a homomolecular structure, but rather consists of a number of different (closely related) structures that cannot be fully characterized. The US Food and Drug Administration (FDA) defines a therapeutic biologic as “a protein derived from living material (such as cells or tissues) used to treat or cure disease” (1).
 Until recently, pharmaceutical companies in the United States had no procedure to follow when submitting applications for “generic” or follow-on versions of biologic drugs (now called biosimilars). And still, no clear guidelines are available for NBCDs. Despite expiring patents on biologics, this was a complicated issue because even slight changes in protein structure (such as small differences in amino-acid sequence) could cause serious side effects (e.g., immunogenic reactions) in patients.” BioProcess International by Vera Weinstein

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“It is estimated that hundreds of new recombinant proteins and monoclonal antibodies (MAbs) enter preclinical and clinical development each year (1, 2). Concomitant global competition in biologics manufacturing has put immense pressure to shorten the time to market. Over the years, cells from various origins have been used for therapeutic protein production (2, 3–5). One of the most economical choices is Escherichia coli, used to make proteins such as human insulin and growth hormone. But the bacteria have some serious shortcomings, such as an inability to perform posttranslational protein modifications (6). Mammalian cell lines such as Chinese hamster ovary (CHO) cells, baby hamster kidney (BHK) cells, or human fibrosarcoma cells have addressed necessary glycosylation in production of certain therapeutic proteins (6). For MAbs, CHO and NS0 cell lines are the most commonly used expression hosts (2, 4).” By BioProcess International

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By Vishal Agrawal, PhD, scientist,  bioproduction group,  Aragen Bioscience
Manjot Bal, PhD, scientist,  University of Texas Southwestern Medical Center’s department of neuroscience in Dallas

 If so Bioproduction Conference and Exhibition 2012 is your must attend event for 2012!

This year we are launching 4 new tailored conference tracks, so all your manufacturing solutions will be answered under one roof. We have a dedicaded stream on Upstream and Analytical Support for Antibodies and Non Antibodies which will concentrating on:

• Latest advances in cell line development – Find out the latest processes on microbial cell line systems for antibodies and non-antibodies, as well as the latest updates on metabolomics and how this information is being used in practice. You will also hear Industry case studies on upstream manufacturability to help streamline and speed up your cell line development process for both antibodies and novel therapeutics
• Streamlining and optimising upstream processing - learn how to overcome the bioprocessing challenges of using non-antibodies
• Key analytical and formulation barriers facing the developments of biosimilars – Understand the manufacturing challenges faced with biosimilars and how they have been overcome to ensure regulatory approval and hear the latest analytical work  carried out
• Advances in high-throughput analytics -  Hear the latest on high-throughput analytical methods for improving bioprocessing and the advantages this will have on your manufacturing process
• Glycosylation – Review  the lastest developments with glycosylation and other post-translational modifications and understand the mechanism of action within this process.
• The role of analytics to optimise upstream development – Catch the latest, cutting-edge analytical methods being used to characterise biologics and optimise upstream and downstream processing. You will also gain an insight into the latest advances with novel analytical technology that is available
• Exclusive workshop focussing on Upstream and Analytical Support for Antibodies and Non Antibodies : Workshop Z- Expression systems for antibodies and their fragments focussing on the newest technologies and methods for expressing antibody related products whilst improving  quality and lowering cost

Louisa Maitland
Bioproduction Researcher Manager
Informa Life sciences

If you plan to attend one conference this autumn make sure it’s BioProduction 2012.  

With more streams, more speakers and mores reasons to attend check out the highlights for this years’ 10^th Annual BioProduction 2012:

• The largest European Biomanufacturing event this year - All your peers will be there! Don’t miss this one-stop event for 2012.

• Our most senior level speaker line up ever! - 65% of speakers are Director level or above; 33% VPs or SVPs.

• A dedicated track on Biosimilars: looking at manufacturing, analytical and regulatory issues. What will the recent release of the FDA’s guidelines mean to you?

• 4 tailored streams – 1 data-driven event focusing on upstream and downstream optimisation, scale-up, disposables, QbD, biosimilars, characterisation, analytics, formulation…plus much, much more

• Come and join in the discussion and benchmark your work with over 70 speakers offering more than 60 Industry case studies.

• Choose from 4 strategic discussion forums: offering interactive conversations and exchange of views focusing on critical industry challenges

• Choose from 8 innovative workshops to help you gain new skills and update your knowledge plus join us for an exclusive site visit to TU Berlin and Medical Biotechnology

• SME Showcase Zone for start-up companies to showcase their products and processes

• Celebrate our 10th Anniversary with talks from Dr Ray Field at Medimmune, Professor Roy Jefferis at University of Birmingham and Professor John Birch former Lonza who all spoke at our first BioProduction event in 2002. Hear their views on how far the industry has come and what the future may hold.

• Over 11 hours of extensive networking opportunities; during the break-out sessions, drinks reception and dinner boat cruise on the River Spree

• In London’s Olympic year- Inspirational speaker Karen Darke, a Paralympic contender will be sharing her incredible feats and challenges since becoming paralysed at the age of 21

Visit the website for more details www.bio-production.com or download the brochure

Louisa Maitland
Bioproduction Researcher Manager
Informa Life sciences

Welcome to our new Informa Life Sciences blog for BioProduction 2012. Here we will keep you  updated on the latest event news and industry updates related to the production of  Antibodies and Non- Antibodies.

Make sure you are part of the largest European Biomanufacturing event this year -  All you peers will be attending!

Taking place this October in Germany, this year we are launching 4 new tailored conference tracks, so all your manufacturing solutions will be answered under one  roof:

Through a combination of 70+ speakers, 60+ case studies, 6 keynote sessions, 8 Case Studies, 4 Strategic Discussion Forums and 11+ hours of exclusive networking activities, BioProduction 2012 brings together the leading decision-makers from across industry and academia to set the agenda for the biopharmaceutical community and drive improvements in the development, production and quality of life saving therapies.

So follow our blog to keep up-to-date on all the congress updates, new speaker announcements, exclusive speaker interviews and industry-relevant news.

Louisa Maitland
Bioproduction Researcher Manager
Informa Life sciences