2 BioProcess International 13(1) January 2015

Volume 13 Number 1 JaNuary 2015

Issue Highlights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4From the Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Editorial Advisory Board . . . . . . . . . . . . . . . . . . . . . . 6Spotlight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Focus on . . . Quality . Fundamental Strategies for Viral Clearance: Exploring the Regulatory Implications . . . . . . . . . . . . . . . . . . . 10 Kathryn Martin Remington

Downstream Processing . Advances in Chromatography Automation . . . . . . . . . . . . . . 16 Anna Quinlan

BPI sPecIal RePoRtsThe Single-Use Watering Hole: Where Innovation Needs Harmonization, Collaboration, and Standardization . . insert James Dean Vogel and Maureen Eustis

The CMC Strategy Forums: Celebrating a Decade of Collaborative Technical and Regulatory Interaction — Part 1, QbD and Risk Management . . . . . . . . . . . . . . . . . . insert Steve Kozlowski, Wassim Nashabeh, Mark Schenerman, Howard Anderson, Ilse Blumentals, Kowid Ho, Rohin Mahtre, Barbara Rellahan, and Victor Vinci, with Lorna McLeod

technIcal aRtIclesPerfusion’s Role in Maintenance of High-Density T-Cell Cultures . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Michelle L Janas, Claudia Nunes, Angela Marenghi, Vincent Sauvage, Brian Davis, Anshika Bajaj, and Andrew Burns

Bioreactor Design for Adherent Cell Culture: The Bolt-On Bioreactor Project, Part 1 — Volumetric Productivity . . . . 28 Marcos Simón

Evaluating Freeze–Thaw Processes in Biopharmaceutical Development: Small-Scale Study Designs . . . . . . . . . . . . . . . . 34 Manasi Puri, Sorina Morar-Mitrica, George Crotts, and Douglas Nesta

elucIdatIonRecruiting and Market Share Reshape Life Sciences Facilities and Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Roger Humphrey

BPI BioMall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46Index of Advertisers . . . . . . . . . . . . . . . . . . . . . . . . . .46

Read more about the articles in this issue on page 4. Find out about this month’s online exclusives on page 9.

oN the CoVerOverconfluent five-day culture of CHO-K1 cells growing on a culture dish — courtesy of author Marcos Simón (www.boltonbioreactor.com).

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©2015 BioProcess International (USPS 0022-044, ISSN 1542-6319) is published eleven times a year by Informa Life Sciences Group at 52 Vanderbilt Ave ., New York, NY 10017, Phone: 1-212-520-2777, fax 1-212-661-5052, www .bioprocessintl .com . Periodicals postage is paid in Westborough, MA and additional mailing offices . POSTMASTER: Send address changes to BioProcess International, PO Box 1170, Skokie, IL 60076 . Canadian publication agreement No . 41067503 . Canadian return address DPGM 7496 Bath Road Unit 2, Mississauga, ON L4T 1L2 . Electronic subscriptions are available online . Articles are abstracted by the Chemical Abstracts database at www .cas .org .

Author Insights — Online Exclusivewww.bioprocessintl.com/bpiextra

4 BioProcess International 13(1) January 2015

iN this issueFocus on QualityWhat types of risk are associated with viral contamination, and what lessons have been learned from contamination incidents so far? On page 10, Kathryn Remington begins a two-part basic introduction to fundamental strategies by exploring important regulatory considerations .

Focus on Downstream ProcessingChromatography automation once was limited to strip recorders and peristaltic pumps — not really true automation . Operators wouldn’t be happy with binders full of strip-recorder paper reels . Intelligent automation is making workflows smarter than ever before . On page 16, Anna Quinlan considers the next steps . Her company interviewed academics, biotechnology R&D scientists, and industrial process engineers about the evolution and future of chromatography automation .

Special Report: Single-Use TechnologyDisposables are growing so fast in range and importance that related organizations can hardly keep up . Contributing to the chaos are company and regulatory needs, market pressures, and even costs . As suggested by Vogel and Eustis in the insert, all parties need to contribute to find a solution to these problems . Regulators recognize a need for standardization and harmonization, and bioindustry would benefit through collaborative efforts toward consensus on standards and best practices . This report provides an update on progress and key issues, with efforts under way among several organizations .

High-Density Perfusion for T CellsAs a rapidly growing element of personalized medicine, T-cell therapies are attracting much interest for their innate abilities to protect against pathogens and to seek and destroy cancerous cells . On page 18, authors from GE Healthcare explore the impact of media perfusion on high-density T-cell cultures . They used a rocking bioreactor to grow primary T cells both with and without media perfusion, then analyzed the impact of perfusion on cell growth and viability . This helped them determine the role that perfusion can play in controlling key metabolites and growth factors .

Special Report: QbD and Risk ManagmentFor over 10 years, the CASSS CMC Strategy Forum series has brought industry and regulators together to address the chemistry, manufacturing, and controls of biopharmaceutical development . This month, our first of several quarterly special reports highlighting topics they have covered focuses on quality by design and risk management . It includes an examination of lessons learned through the A-MAb case study .

Small-Scale Freeze-Thaw StudiesBecause they are prone to instability, biopharmaceutical products in aqueous formulations require special care when manufactured, stored, shipped, and administered . Freezing and thawing techniques are routinely used to improve product stability through manufacturing unit operations such as storage and shipping of process intermediates, drug substances, and formulated drug products . And freeze–thaw parameters can affect overall protein structure and stability . In-depth characterization of the effects is thus an essential element of biopharmaceutical product development . On page 34, authors from GlaxoSmithKline explore small-scale freeze–thaw study design and describe four case studies evaluating monoclonal antibody product quality as a function of freezing and thawing rates, storage temperatures, container–closure systems, and formulation compositions .

Bioreactor Options for Adherent CellsThe Bolt-On Bioreactor (BoB) project is an independent initiative developing a bioreactor for automated and efficient culture of adherent cells . The BoB team believes that a successful alternative to existing devices must address four major challenges: volumetric productivity, process automation, containment and sterility, and process economics . On page 28, a four-part series by Marcos Simón begins by addressing the first of those challenges . He considers available systems to provide a large surface area for optimum cell attachment in a reduced volume and proposes an alternative technology .

Production

Special Report: Single-Use Technology

BPI Online Exclusive ContentBest of BPI Revisited Johannes Gach on Pichia expression

Author Insights

See more on page 8 and online at http://bit.ly/BPI-podcast.

Special Report: QbD and Risk Management

6 BioProcess International 13(1) January 2015

M any publishers are grappling with managing and predicting the course of print and digital publishing . For academic journals with relatively few paid

subscribers and/or association members focusing on specialty subject matter, going digital may make good sense — especially if that can lower subscription costs . However, BPI is a hybrid of reviewed journal and trade publication, addressing many reading and advertising preferences . The choice of which content to offer in print and which to duplicate or offer exclusively in digital format is not entirely clear cut to us . Our controlled-circulation business model rests on the economics of print publishing, with formulaic calculations of advertising:editorial ratios and circulation-auditing requirements . But it allows us to meet the information needs of a fairly broad audience spanning science/technology, different functional groups, business, regulatory affairs, and so on — while providing information to advertisers about who our readers are and what they may plan to purchase . It also lets us offer print subscriptions free to qualified readers .

We control our print circulation to predefined groups of 30,000+ readers in North America and Western Europe . And new data show that an additional 50,000+ readers regularly access our issues digitally outside those mailing areas . The work of qualifying those readers (understanding who they are and what they do) is ongoing . But with a readership of 80,000+, we are reaping the rewards of our digital strategies while encountering editorial challenges along the way .

I may be (figuratively) teetering on the tip of an iceberg here: the debates over print versus electronic, and peer-reviewed versus open-source publishing . But I am no Luddite . Times change, language changes, reading habits change, and business

models and advertising approaches change . I suspect that the scales may tip in favor of broader, rapid dissemination of electronic information over more costly production of limited-circulation physical copies that sit catching dust . But which format really provides the better, more secure legacy?

Of immediate concern amid these transitions is a loss of version control . It is all too easy to upload a file . But sharing a file online is publishing, even if no ink is involved . Asking for first publication rights, as we do, has been a traditional means of controlling quality through review, subsequent revisions, copyediting, and so on . So if we don’t catch the existence of a previous online publication before we go to print with our edited version, which one should readers cite?

Editors who know their audience seek to make all materials understandable across its range of linguistic and technical levels . Copyediting may be even more important these days, when digital readership can cross the globe almost instantly . How can readers discriminate between what is legitimate technical information and what has gone too quickly to the Internet? We want our print and digital versions to be the same, although we might add supplementary material to an online article . We want to adapt to new ways of reading and accessing information based on true reader needs — not always easy to determine . And I’ve reworked the author guidelines, copyright forms, and policy descriptions to make our expectations clear about peer review, copyediting, and reprints . This is so authors will know what to expect in working with us . Together, we can prepare your work for the best possible audience that it can reach .

from the editor

Siddharth Advant, Kemwell BioPharma, USA and IndiaHazel Aranha, Head of Virus Safety, Catalent Pharma Solutions, Raleigh RTP, NC, USAMilton J. Axley, Director, CMC Team Leadership, MedImmune LLC, Gaithersburg, MD, USAR. Lee Buckler, VP Business and Corporate Development, RepliCel Life Sciences Inc ., Vancouver, BC, CanadaPeter Calcott, President, Calcott Consulting LLC, Berkeley CA, USAMichel Chartrain, Distinguished Senior Investigator, Merck and Co ., Rahway, NJ, USAJohn J. Dougherty, Regulatory Scientist, Eli Lilly & Company, Indianapolis, IN, USAJim Faulkner, Vice President, CMC Manufacturing and Supply, Rare Diseases, GlaxoSmithKline R&D, Brentford, UKPete Gagnon, Chief Scientific Officer, Bioprocessing Technology Institute, SingaporeHélène Gazzano-Santoro, Director, Analytical Development and Quality Control, Genentech (Roche) South San Francisco, CA, USATimothy K. Hayes, Vice President and Strategic Regulatory Advisor, ProMetic BioTherapeutics Inc ., League City, TX, USAKenneth Hughes, President, Roker Biotechnologies, Inc ., Toronto, ON, CanadaSusan Dana Jones, Principal Consultant, BioProcess Technology Consultants, Acton, MA, USADennis M. Kraichely, Associate Director and CMC Team Leader, Johnson & Johnson Pharmaceutical R&D, Malvern, PA, USA Blanca Lain, Protein Purification Process Development Consultant, Boston, MA, USA

Adriana E. Manzi, Managing Director, Atheln, Inc ., San Diego, CA, USAOtto-Wilhelm Merten, Gene Therapy Program, Généthon II, Evry, FranceMiriam Monge, Director of Marketing for Integrated Solutions, Sartorius Stedim Biotech, Göttingen, GermanyThomas J. Pritchett, Senior Consultant, Quality Services Consulting, Palm Desert, CA, USAT. Shantha Raju, Scientific Director, Janssen Research and Development, Spring House, PA, USANadine M. Ritter, President and Analytical Advisor, Global Biotech Experts LLC, Alexandria, VA, USA Sally Seaver, President, Seaver Associates LLC, Concord, MA, USARobert P. Shaw, Program Director, EMD Millipore, Billerica, MA, USA Abhinav Shukla, Vice President of Process Development, KBI Biopharma, Raleigh-Durham, NC, USAMichiel Ultee, Chief Scientific Officer for Biologics, Patheon, Princeton, NJ, USAScott M. Wheelwright, Principal Consultant, Complya Asia Co . Ltd ., Suzhou, ChinaWilliam G. Whitford, Senior Technical Market Manager, GE Healthcare Life Sciences, Logan UT, USAShuichi Yamamoto, Professor, Process Design and Engineering Laboratory, Yamaguchi University Graduate School of Medicine, Tokiwadai, JapanJianguo Yang, Chief Scientific Officer and Vice President of Biologics, Qilu Pharmaceuticals, Jinan, ChinaJerry X. Yang, President, DZM Biotech Ltd ., Daqing, China

Members of the BioProcess International Editorial Advisory board volunteer their time to advise the editors about industry trends, technologies, potential authors, and topics of interest. They review all technical manuscripts, and their recommendations help the editors make final publication decisions. Members of the advisory board are not expected to endorse any products, technologies, or companies mentioned; the editors refrain from soliciting reviews from any advisor for whom such a conflict of interest may be involved.

editorial adVisors

8 BioProcess International 13(1) January 2015

spotlightIntroducing Our Niche-Disease Series

by Cheryl ScottA rare or orphan disease affects a small percentage of the population, but with some 7,000 such conditions listed by the Global Genes organization (www .globalgenes .org), they collectively have a significant impact on global health . An estimated 350 million people are affected worldwide — a population that would make up the world’s third largest country all together .

International definitions vary: In the United States, a condition is considered “rare” if it affects <200,000 people; in the United Kindom, a disease is considered rare if it affects <50,000 citizens . One may be considered rare in a given part of the world but common in another . Most rare diseases (80%) are genetic in origin . Half the affected patients are children, and half the conditions have no devoted research foundation .

Some well-known biopharmaceutical companies are devoted to innovating in the orphan-disease segment: e .g ., Alexion, BioMarin, Celgene, Genzyme, Isis, Onyx, Shire, and Vertex . But the vast majority of these conditions (95%) have no FDA-approved treatments . During the first 25 years of the Orphan Drug Act (passed in 1983), 326 such drugs were approved for the US market . Just 350 of the 7,000 orphan diseases are most prevalent — affecting 80% of such patients — and thus the most likely candidates for pharmaceutical intervention . The Health on the Net Foundation lists those online: www .hon .ch/HONselect/RareDiseases . Many of us know someone with a rare disease . For example, my best friend from high school was born with epidermolysis bullosa, which affects one in 50,000 people .

A Big Pharma Approach: Martin Andrews was appointed senior vice president of GlaxoSmithKline for rare diseases in November 2013 . At that time, he discussed the program

online (www .gsk .com/en-gb/our-stories/business-strategy/rare-diseases-qanda-with-martin-andrews) . “We aren’t focusing on a particular disease . Instead we’re focusing on innovative technologies and scientific approaches that can be broadly applied to a number of different areas . That includes biopharmaceuticals, oligonucleotides, and gene therapy alongside more traditional small-molecule products .” That sets GSK apart from many other companies involved in niche-disease research, most of which are smaller organizations .

“I hope we will help further understanding of the diseases that we work on, and so help the field to advance,” said Martin . For example, in working on Duchenne muscular dystrophy, GSK gathered the largest clinical dataset related to the condition, which could help the scientific community’s understanding of DMD .

Delivering medicines for rare diseases involves many challenges . “We are often operating in uncharted territory,” Martin explained . Little or nothing may have been published regarding the natural history of a given disease . “This makes establishing meaningful endpoints to evaluate the impact of investigational medicines challenging . We also need to carefully select diseases for which we believe we can make the most difference . But the biggest challenge for anyone working in this area is to be ultraresilient: It is heartbreaking when things don’t go as planned, and you know what that means for patients and their families .”

I further discussed the practicalities of development with BPI editorial advisor Jim Faulkner (vice president of rare-disease CMC manufacturing and supply at GSK) . “We are in the fortunate position of having a broad and deep research base,” he said . “Consequently, we can be ‘science-led’ regarding the best opportunities in rare diseases that may emerge from our research in any number of therapeutic areas and technical platforms . Criteria that lead us to progress a candidate into development include high unmet medical need; clearly defined disease etiology and mechanism of action; significant probability that a target can be treated with available technologies; and an ability to synergize development costs with (or ‘repurpose’ candidates that have failed for) other indications .”

I wondered why rare-disease programs seemed to be the purvue of smaller companies . “Many facets of rare-disease drug development do not fit easily with the historical ‘big pharma’ model of industrial scale and mass marketing,” Faulkner explained, “such as a potentially small customer base, specialized supply chains, and nonstandard development pathways . So the history of drug development in rare diseases has been dominated by smaller, more specialized ‘niche’ biotech companies . Fortunately, a number of developments have made the case for investing in a specialized rare disease venture much more persuasive .”

Among those, he listed an increased scientific and genetic understanding of rare-disease etiology . The regulatory environment has evolved to include

BPI Online Exclusive ContentBEST OF BPI: REVISITED Expression of a Fab Fragment in CHO and Pichia pastoris: A Comparative Case StudyIn an audiocast with marketing and digital content strategist Leah Rosin, Johannes Gach (professor in the Institute of Applied Microbiology at the University of Natural Resources and Applied Life Sciences in Vienna, Austria) discusses his June 2008 article with coauthors Renate Kunert and Hermann Katinger, “Expression of a Fab Fragment in CHO and Pichia pastoris.” They discussed the status of Fab fragments in the biopharmaceutical pipeline and market as well as both Chinese hamster ovary (CHO) cells and Pichia pastoris yeast expression systems. Gach’s current work focuses on therapeutic antibodies for human immunovirus (HIV) infection.

http://bit.ly/BPI-podcast

9 BioProcess International 13(1) January 2015

spotlightglobal orphan drug policies and FDA initiatives such as breakthrough-therapy designation and priority-review vouchers . “Commercially,” he added, “orphan drugs are characterized by enhanced exclusivity protection, lower marketing costs, faster uptake and appropriate pricing .”

So the past decade has seen big pharma making serious entry into the rare-disease space . GSK set up its dedicated team in 2010, Faulkner reports, to “look for creative solutions to deliver potential medicines to patients — whether through our own internal R&D engine, licensing opportunities, collaborative partnerships, or focused investments .”

With smaller potential markets, it seems that chemistry, manufacturing, and controls (CMC) programs in developing orphan drugs would face even more cost pressure than those working on products with larger potential markets . “CMC development of orphan drugs faces a number of particular challenges,” Faulkner agrees . These include specialized supply chains (“often direct to patient”) that necessitate a highly personalized approach . Rapid progression from clinical data to market (often including a compassionate-use program) usually keeps the process used for clinical supply unchanged when a product launches commercially . That necessitates a very integrated approach to research, development, and manufacturing .”

Low-volume production of orphan drugs often limits their batch history, Faulkner adds, making it difficult to build a significant data set of process operating data . “There is a natural marriage between rare-disease indications and pioneering technologies: cell/gene therapies, antisense oligonucleotides, and therapeutic proteins .” Associated manufacturing technologies can be unproven and highly specialized .

“It simply isn’t possible to bear the cost of a full CMC development program of a new technological platform for a very rare disease,” Faulkner explains, “and still make any kind of return on that investment . Fortunately, regulators recognize that difficulty and are willing to work closely with manufacturers to tailor a CMC registration package that’s ‘fit for purpose’ in a disease with high unmet need — without compromising product quality .”

Finally, there is the issue of competition . What if more than one company targets a given condition? “We do increasingly see competition in a few specialized, established rare disease areas,” says Faulkner, “such as lysosomal storage disorders .” But orphan-drug designation establishes a period of exclusivity for companies that are first to market with a particular treatment modality for a specific indication . “The only way that following companies can break that exclusivity period is if their new treatments are significantly different and offer a superior clinical benefit,” Faulkner says . So if a company initiates a new development program for a condition that already has a treatment, it needs clear reason to believe that the new drug really will be better for patients .

Other countries have their own legal provisions that, like the US Orphan Drug Act, incentivize drug development for rare diseases . You can find a comparison of EU, Japanese, Singaporean, and US legislations at Orphanet online: www .orpha .net/consor/cgi-bin/Education_AboutOrphanDrugs .php . That information is available in French, English, Spanish, German, Italian, Dutch, and Portuguese languages .

Rare Disease Day takes place on the last day of February every year, with an objective of raising awareness among the general public as well as policy-makers, public authorities, industry representatives, researchers, and health professionals . A European campaign began in 2008, the United States joined in 2009, and 2014 saw participation in 84 countries around the world . You can find information about upcoming events and associated partner organizations online at www .rarediseaseday .org .

Watch this space throughout 2015 (and beyond, perhaps) for special briefings on different niche diseases . And I’ll be interested to hear about your companies’ projects along the way . Drop me a note at cscott@bioprocessintl .com .

ISPE Extends FOYA DeadlineThe International Society for Pharmaceutical Engineering (ISPE) has extended your deadline to submit applications for the 2015 Facility of the Year Awards (FOYA) program to 6 February 2015 . These awards recognize the pharmaceutical industry’s accomplishments in facility design, construction, and operation as a means of sharing the development of new applications of technology and cutting-edge approaches . Winning projects set the standard for facilities of the future by demonstrating excellence in project execution, facility integration, innovation, sustainability, process innovation, and operational excellence . You can find more information and apply for consideration online at www .facilityoftheyear .org .

Correction: November 2014 IssueDiane Paskiet was mistakenly listed as an author on “Sterilization Effects on Elastomer Characteristics and Functionality in Parenteral Delivery Systems” in BPI’s November 2014 issue (pages 28–32) . Only Andrea Straka should have been listed . The published article did not include a final round of author changes, but the online version does now .

10 BioProcess International 13(1) January 2015

spotlight

Public Company? Beware of Cyberattacks!Late in 2014, security firm FireEye reported a hacking threat of particular note to the biopharmaceutical industry . Since mid-2013, the FIN4 group has targeted more than 100 publicly traded companies and advisory firms that provide investor, legal, and financial services . Some 68% of targets are involved in healthcare and drug development, fully half of those in biotechnology .

FIN4 knows its targets . “Spearphishing” attempts appear to be written by native English speakers who are familiar with investment terminology and the inner workings of public companies . The scheme does not infect victims with malware, but rather focuses on capturing usernames and passwords that allow FIN4 to view private email correspondence . So-called phishing lures are sent from other victims’ email accounts and hijacked email threads . “These lures appeal to common investor and shareholder concerns,” says FireEye, “enticing intended victims into opening a weaponized document and entering their email credentials .” FIN4 often targets several parties involved in a single business deal, evidence of the group’s organization of collected data . And it has taken steps to evade detection .

What should arouse your suspicions? According to the report, “FIN4’s phishing emails frequently play up shareholder and public disclosure concerns .” For example, one email describes an employee making negative comments about a company and its leadership on public investment forums . The “weaponized” emails are designed to be very difficult to distinguish from legitimate business correspondence . FIN4 has even used false “Windows Security” pop-ups to collect user credentials: e .g ., “Your Outlook session has expired . Please log in to continue .”

FireEye says that the hackers probably use their inside information to capitalize on stock fluctuations . Bloomberg reports that the US FBI is investigating, but the problem is ongoing . Download this free report for more information and suggestions on protecting your company’s information: https://www .fireeye .com/content/dam/fireeye-www/global/en/current-threats/pdfs/rpt-fin4 .pdf .

Addressing the Antimicrobial AgendaThe 2014 BioInfect conference took place at the Alderley Park Conference Centre, Cheshire on the 4th November 2014 . Bionow — a not-for-profit membership organization for biomedical/life-sciences industry — declared the one-day meeting a success . Participants discussed developing innovations for tackling the increasing problem of antibiotic resistance while creating new antiinfective medications .

Scientists, policy-makers, and government officials convened to set the antimicrobial agenda in three main sessions: “Progress: National and International

Perspectives,” “Animal Health: The Issues,” and “Commercial Models .”

In addition, a company technology showcase presented leading innovations and developments in related areas . It included some of the latest innovations from companies in the United Kingdom’s northern region . A number of early stage, proprietary therapeutics are moving away from the broad-spectrum approach toward more focused methodologies somewhat akin to the targeted approach being taken with cancer . Products based on cutting-edge nanopolymer drug delivery technologies were an additional focus along with biologic and vaccine approaches to developing treatments to meet the high unmet medical needs of infectious disease .

BioInfect explored other research into technological tools for health workers to diagnose, manage, monitor, and track emerging infections and drug resistance . Participants considered the discovery and development of novel drugs for treating life-threatening fungal diseases . Such infections typically affect immune-compromised patients, for whom mortality rates can be very high . That patient population is increasing every year due to greater numbers of cancer cases and organ transplants, as well as the use of potent immune-modulating medicines .

Geoff Davison (Bionow’s chief executive officer) says, “We are very pleased with the attendance, engagement, and feedback received . Key areas that can move this agenda forward were discussed . BioInfect brings together professionals from the life-sciences industry, universities, the UK national health service (NHS), government, and policy-making bodies to explore areas that can truly address this problem for mankind . To tackle growing levels of antimicrobial resistance, we need to address this global problem in a truly coordinated way through open and coordinated discussion and planning to ensure that we have a healthcare system that can sustainably control and treat infections .”

Hosted by Bionow and Redx Pharma, BioInfect was supported by AstraZeneca and sponsored by HGF Ltd ., Boyds, and Shore Capital . The 2015 conference is scheduled for Wednesday, 4 November 2015, at the Alderley Park Conference Centre in Cheshire, UK . Find more information online at www .bionow .co .uk .

Correction: November 2014 IssueDiane Paskiet was mistakenly listed as an author on “Sterilization Effects on Elastomer Characteristics and Functionality in Parenteral Delivery Systems” in BPI’s November 2014 issue (pages 28–32) . Only Andrea Straka should have been listed . The published article did not include a final round of author changes, but the online version does now .