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| home > ebr > Spring 2014 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor’s Letter
Promising developments are springing up across biopharma – Deborah O’Neil outlines some of the advances in R&D and biotechnology that emerge in this edition.
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Cell-Based Therapies
Back to the Future
They may be an emerging niche within biopharma, but cell-based therapies are enjoying a steep growth trajectory. R Lee Buckler at Cell Therapy Group, and BioCision’s Rolf Ehrhardt and Maria Thompson outline the new technologies in this area.
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Regenerative Medicine
A New Dimension
As we enter a new pluripotent era of stem cell research, scientists are starting to take advantage of 3D printing technology to produce customised, cutting-edge prosthetics. Regina Au from BioMarketing Insight welcomes the revolution and predicts an exciting future.
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Culturing Cells
Controlled Environment
Sample security, culture efficiency and minimising contamination risk are essential when it comes to culturing cells. Jacqueline van der Zijden of Panasonic Biomedical describes how advances are helping to ensure reliability in the lab.
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Inter-Species Safety
Advancing Xenogeneic Therapy
Peter Gaskin and Kathryn Parsley from PPD examine the growing body of work on the non-clinical testing strategies for xenogeneic products, enabling the safe progression of products from animal models into clinical studies.
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Neutron Crystallography
In the Spotlight
Matthew Blakeley from the Institut Laue-Langevin explores how the combined use of X-rays and neutron crystallography is well-suited to drug development, as a recent study of interactions between a common clinical inhibitor and HIV-1 protease demonstrates.
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Controlled Substances
Chemical Weapons
Cheminformatics applications now being developed can aid researchers in complying with the global plethora of controlled substances regulations. Aurora Costache and Krisztian Niesz at ChemAxon set out some of the features and functionalities.
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Vaccine Production
Taking the Strain
The rapidly expanding demand for vaccine products for viral diseases such as rabies has prompted more sophisticated production techniques based around cell culture systems. K John Morrow, Jr, at Newport Biotech and Ma Sha at Eppendorf, Inc explain.
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Early-Phase Manufacturing
Fast and Flexible
To ensure Phase 1 oral solid dosage formulations are fit for purpose, early-stage manufacturers need approaches that are quick, adaptable and appropriate to the API in question. Jon Sutch at Patheon considers the systems needed.
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Protein Therapeutics
Flexibility in Bioprocessing
Adaptability is the name of the game in bioprocessing, with advances in cell culture, equipment, separation technologies and plastics applications enabling great strides in the production of a broad range of protein therapeutics, says Michiel E Ultee of Gallus BioPharmaceuticals.
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Antibody Engineering
Next-Generation ADCs
As we learn more about antibody drug conjugates, one of the key features for clinical success – and regulatory approval – will be the ability to control the conjugation process to optimise efficacy and safety, as well as to reduce toxicity risk, comments Neil Butt at PolyTherics.
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Tumour Modelling
Imaging of Relevance
The blending of developments in tumour models and imaging technologies is enabling efficient and robust use of the most clinically relevant and predictive models, argue Dick Leopold and Patrick McConville of Molecular Imaging, Inc.
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HPV-Related Cancers
Infection Control
With more HIV-positive individuals facing a growing risk of HPV-related cancers, Eyal Talor at CEL-SCI Corporation stresses the need for further research, such as a recent study looking at immunotherapy against AIN in co-infected subjects.
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Regional Development: Russia
Home Advantage
In a bid to reverse its reliance on imported pharmaceutical products, Russia is boosting the domestic development and manufacturing of innovative drugs through homegrown start-ups and investment. Maria Bomer from Bomer Pharma Consultancy explains.
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In Brief
Follow the Money
Emile Bellott explores the rising tide of biomedical R&D in East Asia – and how it may impact future generations of biotech companies.
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Industry Interview
Human Impact
Octapharma’s Stefan Wietek talks to EBR about the intricacies of developing human proteins and the global demands facing the plasma industry.
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Bioclusters
Group Dynamics
Many small and medium enterprises in the biopharma space are working in clusters to exploit the benefits of a supportive business ecosystem. CEBR’s Claire Skentelbery, Fabrizio Conicella at Bioindustry Park Silvano Fumero and BioWin’s Frédéric Druck report.
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Biotech Investment
Going Public
2013 was the most active year so far for initial public offerings of life sciences companies – and the biotech bonanza is set to continue this year. It can be a great route to success, but Sophie C McGrath of Brown Rudnick urges firms to consider some critical issues before going public.
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News and Press Releases |
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PCI Pharma Services Announces Bottling Line Expansion to Support Customer Needs
Philadelphia, USA – February 5, 2019 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, is pleased to announce the expansion of its bottling line capacity at its Commercial Packaging site in Rockford, IL. Construction of the additional packaging suites began in March 2018 to add considerable footprint for primary and secondary packaging operations equipped with high speed tablet filling, cartoning, as well as in-line serialization and aggregation in support of increased customer demand. The new expansion will grow the robust bottling operation in Rockford by producing an extra 100 million bottles per year.
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White Papers |
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Key to Outsourcing Method Development and Validation: A Pragmatic Approach
RSSL
In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation.
As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP).
Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
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Industry Events |
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Respiratory Drug Delivery (RDD®) Europe 2019
7-10 May 2019, Estoril Congress Center, Lisbon
Respiratory
Drug Delivery (RDD®) Europe 2019 connects emerging and high-level scientists, academics,
industrial and regulatory specialists, and clinicians. It is a must-attend conference
for companies involved in research, development, testing or marketing of
medicines, devices and services associated with pulmonary or nasal pharmaceutical
products. This year, RDD Europe 2019 will be held in Estoril (Lisbon),
Portugal, May 7-10, 2019, and, as in previous years is jointly organized by RDD
Online and Aptar Pharma.
More info >> |
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