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home > ebr > Winter 2013

PUBLICATIONS

European Biopharmaceutical Review

Winter 2013

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BioResearch and Innovation

Cell Based Therapies

Nobels and Stem Cells

The work of Sir John Gurdon and Shinya Yamanaka was recently awarded the Nobel Prize in Physiology or Medicine. Their groundbreaking work has led Dean Griffiths at Cambridge Consultants to investigate how a major discovery can start from a minor question.

Single-use Bioreactors

Rapid Reaction

Traditional stainless steel reactors are being overtaken by single-use bioreactors. Lee Madrid at EMD Millipore Corporation and Aurore Poles-Lahille at Millipore SAS outline the advantages that this new technology can bring.

Discovery Technology

Cloud Computing

Up, Up and Away

Inefficient data processing often stifles innovation in research and development. Richard Heitmann at Aspera discusses the vast possibilities to be gained in new medical advancements when modern technology is used to its full potential.

BioDevelopment

Sharing Data

Personal Medicine

In order to provide more bespoke therapeutics for cancer treatment, the industry needs to make a more conscious effort to collaborate and share patient data, says Markus Warmuth at H3 Biomedicine.

Drug Discovery

Stem Cell Technology

Treatment from Within

Distinguishing the correct cell types in liver cell transplantation is a vital factor that contributes substantially to the success of this therapy. Eric Halioua and Etienne Marc Sokal atPromethera Biosciences explore the advantages that intrahepatic cells have over other sources.

Differentiated Cells

iPS Power

The world of patient therapeutics can be drastically transformed through the use of in vitro differentiated cells that are derived from human induced pluripotent stem cells, Felix Haniel of Axiogenesis AG explains.

Safety Profile

A Marked Difference

Biomarkers are an invaluable tool in drug discovery and development. Federica Crivellente and Elena Vicentini at Aptuit suggest that the use of high throughput technologies can help to generate high quality data in a more efficient and cost-effective way.

Stem Cells in Drug Discovery

Patient in a Dish

Roberto Iacone at Roche and Blake Anson at Celluar Dynamics International examine how using improved induced pluripotent stem cell models will result in more effective medicines and help to overcome some of the challenges in this field.

BioRegional

Biosimilars: Asian Markets

Biotech in China

James C Greenwoodat Biotechnology Industry Organization assesses the growth of the Chinese biotech industry and how investment into new products could secure their position in the drug development and manufacturing market.

DEVELOPMENT AND PRODUCTION

Cell Line Development

Database Power

When trying to identify new cell lines, progress can be stifled by the data management process. If a more highly developed system were to be implemented, development timelines would decrease rapidly, as Eliot Randle at IDBS demonstrates.

Diabetes Therapeutics

Crackling the Code

A promising alternative for the treatment of type 1 diabetes has been discovered. Peter Hosking at Living Cell Technologies illustrates how using encapsulated porcine insulin-producing cells significantly reduces the number of hypoglycaemic events.

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News and Press Releases

Merck Introduces New Integrated Plug & Play Upstream Development Service

• Adaptive approach to cell line development, analytics and clone selection for emerging biotechs and start-up • Tailored upstream development from a single source reduces time to clinic by 20 percent • Fast-track process reduces timeline by 10 weeks for first pharmacodynamic experiment
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White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events

2020 Avoca Quality and Innovation Summit

3-4 June 2020, Amsterdam, The Netherlands

The 2020 Avoca Quality and Innovation Summit will take place 3-4 June 2020, in Amsterdam, The Netherlands.
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