EDITORIAL CALENDAR. The Science & Business of Biopharmaceuticals INTERNATIONAL

Transcription

1 2015 EDITORIAL CALENDAR

2 Content April Outsourcing Resources This special issue reviews the current state-of-the-industry for biopharmaceutical development and manufacturing outsourcing services. The editors review contract services trends, and business, regulatory, and supply chain issues. September The Future of This special issue examines the evolving technologies, drug developer/contractor relationships, supply chain challenges, globalization, and regulatory oversight that are shaping the way biopharmaceuticals are manufactured. December Corporate Capabilities This supplement incorporates full-page descriptions of products and services from the industry s leading suppliers. Contact your sales representative for details. Editorial Coverage: Expert Insight and Analysis BioPharm International provides the biopharmaceutical industry with comprehensive coverage of key scientific, technology, regulatory, and business topics. The editorial mix of peer-reviewed papers, practical advice on managing bioprocessing and technology, regulatory and business columns, and expert commentary provides comprehensive coverage of upstream and downstream processing, manufacturing operations, regulations, formulation, scale up/technology transfer, quality by design, drug delivery, and analytical testing. BioPharm Volume 27 Number 4 BioPharm International I NTE R NATI O NAL April 2014 Growth Testing for Disposable Bags Photo Credit: Nicholas Rigg/Getty Images Special Themed Supplements Peer-reviewed Technical Notes BioPharm International publishes peera Generic Growth Test Method for Improving Quality reviewed papers in the form of technical Control of Disposables in Industrial Cell Culture case studies/application notes; topical literature or patent reviews; novel R research; or science-based opinion papers. All papers undergo a double-blind peerreview process by Editorial Advisory Board of leading scientists, managers, directors, and consultants. APRIL Raw Materials I Supply Chain I Quality by Design mabs Unlock the Biosimilars Market Volume 27 Number 4 PEER-REVIEWED BUSINESS SYNTHETIC PEPTIDES IMPLICATIONS OF TRACE LEVELS OF REDOX-ACTIVE METALS IN DRUG-PRODUCT FORMULATION BIOTECH IPOS ON A HOT STREAK CONTROL STRATEGIES FOR SYNTHETIC THERAPEUTIC PEPTIDE APIS PART II BIOPHARMA OUTSOURCING ACTIVITIES UPDATE The contributors from biopharmaceutical and industry supplier companies, columnists, and the editorial staff are experts with specialized knowledge and experience in their fields. Through expert interviews, roundtable discussions, literature reviews, and survey analyses, the editors report on emerging trends, strategies, and best practices in these key areas. Brian Horvath, Valerie Liu Tsang, Weimin Lin, Xiao-Ping Dai, Kurt Kunas, and Greg Frank ABSTRACT Disposable bags are widely used in the biotechnology industry. The two main purposes are to store cell-culture media and to grow cells for inoculum or production. Several groups have reported growth inhibition resulting from the use of such products. This report shows independent data from four companies, using several different cell lines and growth media, and suggests a method that can be implemented for quality control at disposable-bag vendors. ecent ly, a g roup of eng ineers and scientists within t he c e l l - c u lt u r e p r o c e s s d e ve lopme nt c om mu n it y convened the first inaug ural CellC u lt u r e I ndu st r y For u m (C C I F ), wh ic h wa s he ld i n L ong mont, Colorado, in Febr uar y More t ha n 30 ind iv idua ls f rom n ine companies met over three days to present topics related to the common challenges and problems within the large-scale cell-culture industry. A highlighted theme at the first forum was the observation of cell growth i n h ibit ion, pre su mably re su lt i ng f rom t he use of d isposable bags. Disposables are widely used in the biotechnology industry for numerous bioprocessing functions. Extractables and leachables from disposables are frequently discussed (1). Two of the PEER-REVIEWED functions of disposable bags in the Article submitted: March 5, i ndust r y a re to store cel l- c u lt u re Article accepted: May 1, media and to grow cells within the *Brian Horvath is a scientist at Process Technical Development, Late Stage Cell Culture, Genentech, a member of the Roche Group, South San Francisco, CA 94110; Valerie Liu Tsang is senior engineer III and Weimin Lin is a scientist, both at Cell Culture Development, Biogen Idec, RTP, NC 27709; Xiao-Ping Dai is manager at Cell Culture Science, Global Manufacturing and Supply, Bristol-Myers Squibb Company, Bloomsbury, NJ 08804; Kurt Kunas is a principal scientist and Greg Frank is a principal engineer, both at Amgen, Thousand Oaks, CA * To whom all correspondence should be addressed, bhorvath@gene.com. 34 bags at all steps of cell culture-based manufacturing. At the meeting, as well as described in other for ums (2 6), it was clear that cell growth was sometimes affected by the use of disposables for these applications. A subteam was formed after the CCIF adjourned to further discuss and act upon these observations. This paper describes collaboration in which four of the participating CCIF companies jointly assessed cell growth inhibition resulting from the use of disposable cell-culture bags (hereafter referred to as bags). The assessments are meant to uncover subtle effects on cell growth when medium is warmed in bags prior to use in cell-culture steps. Developing a widely applicable growth test is not a trivial exercise it should be cell line- and media-independent so that vendors can apply it with confidence and avoid unwanted false-positive results. To that end, data are shown BioPharm International June 2013 New products for bioprocessing applications and analytical testing are profiled in each issue. Service contract providers and users stay current on trends, partnerships, and business activities through the monthly column, authored by Jim Miller of PharmSource Information Services and Eric Langer, president and managing partner of BioPlan Associates. Key Topics Covered in BioPharm International Analytical Method Development and Validation Aseptic Processing Business Development and Investment Strategies Continuous Biomanufacturing Contract Biomanufacturing Drug Delivery Systems Expression Systems Fill/Finish Formulation Trends Lyophilization Manufacturing and Equipment Trends Modular Systems Process Controls Process Modeling Protein Aggregation Protein Characterization Scale Up and Tech Transfer Single-use Systems Stabilization Features and Analysis on Topics Quality Analytics

3 January Space Deadline: December 10 Material Deadline: December 16 Outlook: Manufacturing and Equipment Trends Fermentation Affinity Media Protein Aggregation Process Validation Biosimilar Analysis Raw Materials Supply Chain Business/Market Monoclonal Antibodies PepTalk Preview in PepTalk, Jan , San Diego CASSS WCBP, Jan , Washington, DC February Space Deadline: January 12 Material Deadline: January 16 Analytical Method Development and Validation Protein Expression Buffers and Process Liquids Process Modeling Extractables/Leachables Traditional vs. Single Use vs. Hybrid Business/Market Biosimilars Pittcon Preview in Biomanufacturing Summit, Feb , San Diego Pittcon, March 8-12, New Orleans March Space Deadline: February 10 Material Deadline: February 17 Advances in Protein Characterization Raw Materials Size-Exclusion Chromatography Cleaning Validation Corrective and Preventive Action Stability Testing Finished Product Supply Chain Business/Market Antibody Drug Conjugates Partnering Interphex Preview in PDA Annual Meeting, March 16-18, Las Vegas, NV BDP Week, March 30-April 2, Huntington Beach, CA World Vaccines Congress, April 7-10, Washington, DC

4 April Space Deadline: March 10 Material Deadline: March 16 Continuous Biomanufacturing Single-use Systems Ion Exchange Chromatography Formulation Lot Release Testing Storage Systems Business/Market Vaccines Special Themed Supplement Outsourcing Resources Interphex Exhibitor Showcase in Full-page Profile in Interphex Show Highlights Section (Full-page Advertisers only) INTERPHEX, April 21-23, New York CHI-PEGs Summit, May 5-9, Boston May Space Deadline: April 10 Material Deadline: April 16 Modular Systems Bioreactors Separation and Purification Expression Systems Quality Metrics Raw Materials Testing Cold Chain Business/Market Clinical Trial Materials AAPS Biotech Preview in AAPS National Biotechnology Conference, June 8-10, San Francisco June Space Deadline: May 11 Material Deadline: May 15 Scale Up and Tech Transfer Cell Line Engineering Sterile Filtration Stabilization Adventitious Agent Testing Cleanroom Systems and Supplies Business/Market Monoclonal Antibodies Intellectual Property Protection BIO International Show Guide BIO Preview in BioPharm International s e-bulletin Newsletter BIO International Convention, June 15-18, Philadelphia

5 July Space Deadline: June 10 Material Deadline: June 16 Aseptic Processing Media Supplements Single-Use Systems Process Controls Risk Assessment and Mitigation Biosafety Testing Packaging Trends Business/Market Gene Therapies FREE Product/Service Innovation Profile Page (Full-page Advertisers) August Space Deadline: July 10 Material Deadline: July 16 Drug Delivery Systems Cell Banking Bioburden Reduction Purification Column Selection Environmental Testing Fluid Handling Systems Business/Market Protein Therapeutics FREE Ad Performance Study Corporate Capabilities Incentive: Advertise in July and August and Receive a Free Corporate Capabilities Profile in December (See Your Sales Representative for Details) September Space Deadline: August 10 Material Deadline: August 14 Contract Biomanufacturing Protein Engineering Cell Harvesting Protein Characterization Equipment Qualification HPLC Method Development Shipping Services Business/Market Vaccines Partnering Special Themed Supplement The Future of Product/Service Profile in PDA/FDA Joint Regulatory Conference, Sept , Washington, DC

6 October Space Deadline: September 10 Material Deadline: September 16 Formulation Trends Glycosylation Centrifuges Single-use Systems Light Scattering Methods Lab Equipment Business/Market Monoclonal Antibodies Free 3-minute Podcast - posted online and ed (one month) AAPS Preview in BioPharm International s e-bulletin Newsletter AAPS, Oct , Orlando, FL November Space Deadline: October 12 Material Deadline: October 16 Fill/Finish Cell Culture Process Chromatography Viral Clearance Investigations/Root Causes Residual Impurities Testing Serialization Business/Market Stem Cell Free Application Note in BioPharm International s App Note Newsletter (Lead Generation) December Space Deadline: November 10 Material Deadline: November17 Outlook: Business Development and Investment Strategies Annual Employment Survey Contract Process Services Purification Lyophilization Mycoplasma Testing Utility Systems Business/Market Cell Therapy Intellectual Property Protection Special Themed Supplement Corporate Capabilities Corporate Profile in Corporate Capabilities Supplement (Ask your sales representative for details)