US, Euro regulators approve drug purification process

US, Euro regulators approve drug purification process

NEWS Editorial Office: Elsevier Advanced Technology, P O Box 150, Kidlington Oxford OX5 1AS, UK Tel: +44 (0)1865 843239 Fax: +44 (0)1865 843971 E-mail...

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NEWS Editorial Office: Elsevier Advanced Technology, P O Box 150, Kidlington Oxford OX5 1AS, UK Tel: +44 (0)1865 843239 Fax: +44 (0)1865 843971 E-mail: [email protected]

Editor: Steve Barrett

Contributing Editor: Simon Atkinson Tel/Fax: +44 (0)1608 641631 E-mail: [email protected]

Production Coordinator: Ben Pelling Editorial advisory board: Dr P Ball (Pall Europe), Dr D Bessarabov (Kvaerner Chemetics, A Division of Kvaerner Canada Inc, Canada), Prof. M Cheryan (University of Illinois at Urbana-Champaign), Prof. A Fane (University of New South Wales), Dr T Franken (Membrane Application Centre Twente), Dr E Gobina (Robert Gordon University), Dr A Merry (PCI Membrane Systems), Prof. M Nyström (Lappeenranta University of Technology), Dr G Pearce (Kalsep), Dr P Pfromm (Institute of Paper Science & Technology, GA, USA), Dr R Philpott (Whatman International), Dr A Turner (AEA Technology), Prof. R Wakeman (Loughborough University of Technology), Prof. A Yaroshchuk (Ukrainian Academy of Sciences). Permissions may be sought directly from Elsevier Rights & Permissions Department, PO Box 800, Oxford OX5 1DX, UK; tel: +44 (0)1865 843830, fax: +44 (0)1865 853333, e-mail: permissions@ elsevier.com. You may also contact Rights & Permissions directly through Elsevier’s home page (http://www.elsevier.com), selecting first ‘Customer Support’, then ‘General Information’, then ‘Permissions Query Form’. In the USA, users may clear permissions and make payments through the Copyright Clearance Center, Inc, 222 Rosewood Drive, Danvers, MA 01923, USA; tel: 978 7508400, fax: +1 978 7504744, and in the UK through the Copyright Licensing Agency Rapid Clearance Service (CLARCS), 90 Tottenham Court Road, London W1P 0LP, UK; tel: +44 (0) 171 436 5931; fax: +44 (0)171 436 3986. Other countries may have a local reprographic rights agency for payments. Derivative Works Subscribers may reproduce tables of contents or prepare lists of articles including abstracts for internal circulation within their institutions. Permission of the publisher is required for resale or distribution outside the institution. Permission of the publisher is required for all other derivative works, including compilations and translations. Electronic Storage or Usage Permission of the publisher is required to store or use electronically any material contained in this journal, including any article or part of an article. Contact the publisher at the address indicated. Except as outlined above, no part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission of the publisher. Address permissions requests to: Elsevier Rights & Permissions Department, at the mail, fax and e-mail addresses noted above. Notice No responsibility is assumed by the publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made. Although all advertising material is expected to conform to ethical (medical) standards, inclusion in this publication does not constitute a guarantee or endorsement of the quality or value of such product or of the claims made of it by its manufacturer.

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Millipore introduces Polysep and Brewpore Massachusetts-based Millipore has announced the availability of its Polysep II media, and Brewpore caustic-resistant cartridge filters. Polysep II media has a triple-layer design to improve process efficiency and extend the life of expensive final filters, says the company. Offering high retention, flow rate and throughput, it claims that the configuration provides reliable pre-filtration for sterilizing-grade membranes in aqueous-based applications. Comprising borosilicate glass media and two cellulosic membranes, the integrated 1.0/0.2/0.1 µm media combines the dirt holding capacity of a depth filter with the retention efficiency of a membrane filter, and is ideal for use in cell culture and other media filtration applications. In addition, the Polysep II triple-layer media can be used to create scalable systems – from benchtop to full-scale manufacturing. The Polysep II media configuration is currently available in cartridge filters, and Opticap XL and XLT disposable capsules. Millipore says that it will be added to OptiScale smallscale devices later this year. Made from Millipore’s patented Durapore polyvinylidene fluoride membrane and polypropylene components, the Brewpore 0.55 µm cartridge filters offer broad chemical compatibility with commonly used sanitizing agents. Designed for the microbiological stabilization of beer and malt-based beverages, they are resistant to thermal stress and repeated exposure to hot water and caustics. The filters support demanding process conditions found during the removal of particles, yeast and spoilage organisms, says the company. In addition, the filters are qualified using a high-pressure forward and reverse pulse test. They are available in a variety of lengths. Contact: Millipore Corporation, 290 Concord Road, Billerica, MA 01821, USA. Tel: +1 978 715 4321, Fax: +1 781 533 3110, Web: www.millipore.com

Mini-UniPrep aids sample preparation

Pakistani membrane plant comes on stream

Separations technology company Whatman Inc has extended its Mini-UniPrep ‘syringeless’ filter family. The company has developed an entire family of Mini-UniPrep filters to meet specific customer needs, particularly those in the pharmaceutical and environmental markets. For customers using robotics to maximize throughput, it is offering the Slit Septa ‘syringeless’ filter. This enables Mini-UniPrep to be used with current robotics on high performance liquid chromatography instruments, eliminating coring problems associated with repeated sampling. Designed to meet the US Pharmacopeia specifications for light resistance, the amber MiniUniPrep syringeless filter has been developed for customers who need to protect samples, such as vitamins or catecholamine, from being damaged by light. It prevents photodegradation of lightsensitive samples using the same colorant as pharmaceutical containers. Housed in durable polypropylene, the filters are compatible with all major auto-samplers, and they are available in pore sizes of 0.2 µm and 0.45 µm to meet specific sample application requirements. Whatman claims that the MiniUniPrep product reduces sample batch processing time by up to one-third. Its use will enhance laboratory productivity, and reduce the need for consumables such as syringes, sample cups and transfer containers that are needed for sample preparation.

The Oil & Gas Development Co Ltd (OGDCL) in Pakistan has announced the successful startup of its newly expanded natural gas membrane plant, located in Qadirpur. The installation of an enhanced pretreatment system included a chiller, a MemGuard unit and an improved Separex membrane system using cellulose acetate plus technology from US company UOP. The capacity of the existing membrane plant, rated at 235 mmscfd (millions of standard cubic feet per day), was expanded to 400 mmscfd. UOP has also delivered two new membrane skid-mounted units that will enable OGDCL to further increase sales gas production to 500 mmscfd later this year. UOP reports that the plant is meeting all of its performance guarantees, including those for CO2 and H2S removal and hydrocarbon recovery. The Qadirpur facility is one of the largest operating membrane plants of its kind in the world, claims UOP.

Contacts: Whatman Inc, 9 Bridewell Place, Clifton, NJ 07014, USA. Tel: +1 973 773 5800, Fax: +1 973 472 6949, Web: www.whatman.com Whatman Plc, Whatman House, St Leonard’s Road, 20/20 Maidstone, Kent ME16 0LS, UK. Tel: +44 1622 676670, Fax: +44 1622 677011, Web: ww.whatman.co.uk

Contact: UOP LLC, 25 East Algonquin Road, Des Plaines, IL 60017-5017, USA. Tel: +1 847 375 7801, Web: www.uop.com

US, Euro regulators approve drug purification process US-based BioMarin Pharmaceutical Inc has been granted a licence by the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) for a drug product that uses a dual membranebased process developed by Pall Corporation. The new purification process eliminates the need for DNA testing, and enhances the removal of potential virus contaminants from protein-based drugs. The

Membrane Technology May 2004

NEWS manufacturing step that incorporates the Pall Mustang Q ionexchange membrane was able to remove DNA to more than 100 million-fold below the level of detection, enabling BioMarin to ensure the purity of Aldurazyme (laronidase), an enzyme replacement therapy for the treatment of the genetic disorder, mucopolysaccharidosis I. Following the appropriate testing and validation of this process step, BioMarin is exempt from batch-release DNA testing. BioMarin’s findings set a new standard in the safety and purity of protein-based drugs, says Jerold Martin, senior vice president and global technical director of Pall Life Sciences. According to Martin, Mustang Q membrane technology significantly reduces the possibility of a failed batch caused by DNA contamination – an extremely costly problem, which also has potential health implications for people. In addition, BioMarin found that combining the Mustang Q membrane unit with the Pall Ultipor VF grade DV50 virus filter also significantly increases virus removal capacity and drug safety. The combined performance of these products marks the first time that two membrane-based technologies have been formally recognized by the FDA and EMEA as complementary methods of viral clearance in the manufacture of a licensed drug product, says Pall. Both regulatory agencies stipulate the need for orthogonal (independent) methods of viral clearance from protein drugs during manufacture, based on the premise that different mechanisms of purification provide cumulative performance. The Ultipor VF DV50 filter removes viruses by size exclusion, while the Mustang Q chromatography membrane removes viruses by adsorption. Contact: Pall Corporation, 2200 Northern Boulevard, East Hills, NY 11548, USA. Tel: +1 516 484 5400, Fax: +1 516 484 3649, Web: www.pall.com

Sartorius posts strong results German process technology supplier Sartorius Group has posted

strong results for fiscal 2003, and is striving to increase sales revenue and double its operating earnings in 2004. Spokesman for the executive board and group chief executive officer Dr Joachim Kreuzburg, says: ‘In 2003, we improved our cost structures for the long term and, despite substantial extraordinary expenses, were able to increase our earnings and lower debt by more than 20%. For 2004, our major targets will be to further improve our profitability along with reporting correspondingly higher earnings.’ To achieve this, Kreuzburg says that the company needs to continue boosting efficiency, and earn additional gross profit margins from its planned sales revenue growth. In 2003, Sartorius increased earnings before interest and taxes (EBIT) by 8.6% to 14.7 million, from the 13.5 million which it reported a year earlier. Earnings before interest, taxes, depreciation and amortization were 3.9% higher at 37.7 million, against the previous year’s figure of 36.3 million. These earnings contain one-time extraordinary expenses of about 5 million for restructuring measures, and about 3 million for the insolvency of the minority stake Diessel GmbH & Co Kg. At an EBIT of 7.6 million, the Biotechnology Division contributed the largest share of the group’s earnings. In 2003, the group’s sales revenues decreased by 7.2% to 442.3 million, from 476.5 million in 2002, particularly because of the impact of foreign exchange rates. The Biotechnology Division posted a decline in sales revenue of 10.4% to 227.1 million, from 254.6 million a year earlier. For fiscal 2004, the Group anticipates that overall earnings will substantially improve. It says that this is bound to occur in tandem with sales revenue growth, and be promoted by improved cost structures following the implementation of consolidation measures. Contact: Sartorius AG, Weender Landstrasse 94108, D-37075 Goettingen, Germany. Tel: +49 551 3080, Fax: +49 551 308 289, Web: www.sartorius.com

US desalination plant market studied Research published by Frost & Sullivan reveals that the desalination plant market in the US reached $237.3 million in 2000, but faltered in 2001 and 2002, dropping to $189.0 million and $80.4 million, respectively. However, according to a new study, US Desalination Plant Markets, there was a considerable jump in 2003, with the sea-water plant in Tampa Bay, Florida coming onstream. Future years are expected to see sustained growth as was witnessed throughout the 1990s, although it is likely that the plant in Tampa Bay is a temporary spike in the market, says the market research company. The threat of localized water shortages in the US, although most evident in the west, is becoming alarmingly common in southern states such as Florida, Georgia, Texas and New Mexico. Regional efforts are being taken to address this growing problem, and alternative sources for freshwater, such as sustainable desalination approaches, are being explored. Florida, like many other coastal states, faces drought conditions, salt-water intrusion and a rapidly growing population – all compounding the already stressed water supplies. To combat the problem, it is turning to desalination, building one of the largest plants in the US in Tampa Bay. One factor giving some in the industry pause to adopt this method is the cost involved, says Frost & Sullivan. Desalination costs more than treating relatively saltfree surface water and groundwater, but the growing demand for fresh water in many areas of the nation has spurred unprecedented interest in the process of desalting sea water, or brackish water, as a means of increasing water supplies. Perhaps the most significant and far-reaching restraint in the US desalination market is environmental concerns, says the study. Environmental lobby groups and public opposition can be a powerful tool against the development of desalination plants. However, there are no fatal flaws in desalination

In Brief Toray renames Ropur water treatment firm Swiss company Ropur AG, the exclusive distributor of Toray membrane products for Europe, the Middle East and Africa, has changed its name to Toray Membrane Europe AG. During March 2003, Toray acquired the majority share in Ropur. The share capital of Toray Membrane Europe amounts to SFr1.25 million (US$950 000). Toray holds 60%, while local management and Mitsui Bussan Plant & Project Corporation (Japan) hold 30% and 10%, respectively. Toray Membrane Europe has branch and sales offices in Barcelona and the Canary Isles (Spain), Dubai in the United Arab Emirates and Amman in Jordan. Ciphergen expands licence agreement with Genencor US-based Ciphergen Biosystems Inc has expanded its existing licence agreement with Genencor International Inc covering the production and marketing of products based on proprietary hydrophobic charge induction chromatography technology developed by Genencor. Ciphergen uses this technology to produce MEP HyperCel, a highcapacity, high-selectivity sorbent, at its BioSepra process chromatography division. Under the expanded terms of the agreement, Ciphergen has the exclusive, worldwide right to use Genencor’s technology for the production of MEP chromatographic sorbents as well as MEP membranes. Pennvest approves $97m for water projects In the US, the board of directors of the Pennsylvania Infrastructure Investment Authority (Pennvest) has adopted guidelines for a new program to help communities to rehabilitate brownfield sites. It will provide low-interest loans for both remedial activities at these sites and for the construction of the waterrelated infrastructure. The board approved funding for a number of drinking water projects, including a membrane filtration system for the Saxton Borough Municipal Authority in Bedford County, which will be used to protect authority customers from Giardia and other possible contaminants.

3 Membrane Technology May 2004