2019 editorial calendarfiles.pharmtech.com/alfresco_images/pharma/2018/10/... · » analytical best...

Covering the biopharmaceutical development and manufacturing industry since 1988

www.biopharminternational.com

2019 EDITORIAL CALENDAR

The Science & Business of Biopharmaceuticals

INTERNATIONAL

EDITORIAL COVERAGE



INTERNATIONAL

EXPERT INSIGHT AND ANALYSISBioPharm 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, drug delivery, analytical testing, and more.

The print and digital editorial coverage provides technical and business insight and analysis for all biologic-based therapies including monoclonal antibodies, biosimilars/biobetters, protein therapeutics, vaccines, cell therapies, gene therapies, antibody-drug conjugates, and other emerging therapies.

Through expert interviews, roundtable discussions, literature reviews, and survey analyses, the editors report on emerging trends, strategies, and best practices in key areas.

To learn about contributions, visit: www.biopharminternational. com/biopharm-international-info-authors.

SPECIAL COVERAGEThroughout 2019, the editors will report on strategies biopharma companies can use to transform biopharmaceutical development and manufacturing using leading-edge technologies and methods to increase quality output and reduce costs.

EDITORIAL FEATURESPeer-Reviewed Research PapersBioPharm International publishes peer-reviewed papers in the form of technical case studies/application notes; topical literature or patent reviews; novel research; or science-based opinion papers. All papers undergo a double-blind peer-review process by BioPharm International’s Editorial Advisory Board of leading scientists, managers, directors, and consultants.

Technical ArticlesFeature articles in BioPharm International offer timely technical and scientific discussions of ongoing drug development challenges and solutions. Articles are authored by industry experts and the magazine’s editorial team. Topics cover the full spectrum of biopharmaceutical development and manufacturing including upstream processing, downstream processing, manufacturing, quality and regulations, analytics, facilities and equipment, laboratory operations, packaging, logistics, supply chain, and business issues including intellectual property, market research, and funding.

Regulatory BeatThe latest developments, guidance documents, and enforcement action from international regulatory authorities, as well as expert analysis, are addressed in this monthly feature.

Ask the Compliance ExpertQuestions about enforcement, standard operating procedures, working with FDA, and other compliance issues are answered by regulatory experts.

Perspectives on OutsourcingContract service providers and users stay current on trends, partnerships, and business activities through the Perspectives on Outsourcing column.

SPECIAL ISSUESAprilOutsourcing Resources eBookThe editors examine trends, partnerships, manufacturing capacity, regulatory, supply chain, and technical expertise issues at contract development and manufacturing service organizations

JuneSingle-Use Systems Advance Commercial Production eBookThe editors examine the technology, practices, and regulatory approval questions facing companies employing single-use technologies for commercial manufacturing.

September and DecemberThe complex web of biopharmaceutical regulations can be difficult to navigate. The editors provide a handy digital guidebook to international guidelines and regulations, as well as expert advice, updated quarterly.

OctoberBioprocessing Application NotebookA compendium of case studies, application notes, and posters on a range of biopharmaceutical development and manufacturing processes.




INTERNATIONAL

JanuaryAd Close: December 11, 2018

Focus » Transforming Biopharmaceutical

Development and Manufacturing » Employment Survey

Peer-Reviewed Research/Technical Notes

Pipeline » Gene Therapies

Upstream Processing » Cell Culture

Downstream Processing » Separation and Purification

Manufacturing » Facilities

Quality/Regulations » API Development and Approval Trends

Analytics » Stability Testing

Operations » Process Monitoring/Controls

BioBusiness » Economic Development

Outsourcing » Perspectives on Outsourcing

Departments » Regulatory Beat » Product Spotlight » Ask the Compliance Expert

Shows » CASSS–WCBP, Jan. 29–31,

Washington, DC

Value-Added » FREE Direct eResponse Ad Leads

(Ask your rep for details.)

FebruaryAd Close: January 9

Focus » Analytical Instruments and Methods


Development » Protein Therapeutics

Upstream Processing » Single-use Systems

Downstream Processing » Lyophilization

Manufacturing » Fill/Finish

Quality/Regulations » Investigations/Root Causes

Analytics » Method Development

Operations » Lab Operations

Supply Chain » Cold Chain

Outsourcing » Analytical Tips and Trends


Shows » PDA Annual Meeting, March 11–13,

San Diego, CA » BioProcess International West,

March 11–14, Santa Clara, CA

Value-Added » New Tech Showcase (Print)

MarchAd Close: February 7Focus » Drug Development:

Alternative Dosage Forms


Pipeline » Biosimilars/Biobetters

Upstream Processing » Bioreactors

Downstream Processing » Membranes

Manufacturing » Automation

Quality/Regulations » Process Validation

Analytics » Lab Data Integrity » Analytical Best Practices

Operations » Prefilled Syringes

BioBusiness » Global Biopharma Markets



Shows » Pittcon, March 17–21, Philadephia, PA » DCAT Week, March 19–22, New York, NY » Bio Europe Spring, March 25–27,

Vienna, Austria » INTERPHEX, April 2–4, New York, NY » CHI Pegs, April 8–12, Boston, MA » World Vaccines Congress, April 14–17,

Washington, DC

Value-Added » INTERPHEX Exhibitor Guide BioPharm

International’s eBulletin Newsletter » INTERPHEX Exhibitor Guide (Print)

AprilAd Close: March 13

Focus » Process Development


Development » Antibody-Drug Conjugates

Upstream Processing » Biochemicals and Raw Materials

Downstream Processing » What’s New in Downstream Technologies

Manufacturing » Cleaning Processes

Quality/Regulations » International Regulations

Analytics » Glycosylation

Operations » Equipment

BioBusiness » Intellectual Property

Outsourcing » Development Tips and Trends


Shows » CPhI North America, April 30–May 2,

Chicago, IL » Bioassays 2019: Scientific Approaches

and Regulatory Strategies (CASSS), May 6–7, Gaithersburg, MD

Value-Added » New Tech Showcase (Print) » CPhI North America Exhibitor

Guide in BioPharm International’s eBulletin Newsletter

» CPhI North America Exhibitor Guide (Print)

Special Themed eBookOutsourcing ResourcesA review of the market for outsourced contract services, including manufacturing, development, and supply chain issues.




INTERNATIONAL

MayAd Close: April 11

Focus » Fill/Finish


Pipeline » Cell Therapies

Upstream Processing » What’s New in Upstream Technologies

Downstream Processing » Single-Use Manufacturing

Manufacturing » Aseptic Manufacturing Processes

Quality/Regulations » Critical Quality Attributes

Analytics » Cleaning Validation


BioBusiness » Investment Outlook



Shows » BIO International Convention,

June 3–6, Philadelphia, PA

Value-Added » BIO International Enhanced Exhibitor

Showcase (1/4-page equivalent) » BIO Preview in BioPharm

International’s eBulletin Newsletter

June Ad Close: May 13

Focus » Drug Delivery Systems


Development » Monoclonal Antibodies

Upstream Processing » Expression Systems

Downstream Processing » QbD for Downstream Processing

Manufacturing » What’s New in Manufacturing

Quality/Regulations » Good Laboratory Practices

Analytics » Data Analytics


Supply Chain » Drug Supply Security

Outsourcing » Manufacturing Tips and Trends


Value-Added » New Tech Showcase (Print)

Special Themed eBookSingle-Use Systems Advance Commercial ProductionA review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs.

JulyAd Close: June 12

Focus » Downstream Processing


Pipeline » Nucleic Acids

Upstream Processing » QbD for Upstream Processing

Downstream Processing » Residual Impurities

Manufacturing » Facilities

Quality/Regulations » Data Integrity

Analytics » Adventitious Agent Testing

Operations » Equipment

BioBusiness » Economic Development



Value-Added » FREE Product/Service

Innovation Profile Page (Full-page Advertisers)

AugustAd Close: July 11

Focus » Cell-Line Development


Development » Gene Therapies

Upstream Processing » Media and Supplements

Downstream Processing » Cell Harvesting

Manufacturing » Single-Use vs. Stainless Steel

Quality/Regulations » Quality Culture/Training

Analytics » Protein Characterization


Supply Chain » Logistics/Shipping

Outsourcing » Analytical Tips and Trends


Shows » The Bioprocessing Summit,

August, Location TBD

Value-Added » New Tech Showcase (Print) » FREE Direct eResponse Ad Leads

(Ask your rep for details.)




INTERNATIONAL

SeptemberAd Close: August 12

Focus » Stability Testing


Pipeline » Antibody Drug Conjugates

Upstream Processing » Bioreactor Performance

Downstream Processing » Process Chromatography

Manufacturing » What’s New in Manufacturing

Quality/Regulations » GMPs

Analytics » Biosimilar Analysis

Operations » Container Closures

BioBusiness » Global Biopharma Markets



Shows » Biotech Week Boston,

Sept. 9–12, Boston, MA » PDA/FDA, September, Location TBD

Value-Added » New Tech Showcase (Print) » Product/Service Profile in BioPharm


Special Themed eBookBioPharm International’s Regulatory Sourcebook and ReferenceAn updated compilation of regulations, guidances, compendial documents, position papers, and enforcement actions from global regulatory authorities.

OctoberAd Close: September 11

Focus » Continuous Manufacturing


Development » Biosimilars/Biobetters

Upstream Processing » Cell-Line Quality

Downstream Processing » Manufacturing Data Integrity

Manufacturing » Process Analytical Testing

Quality/Regulations » Equipment Qualification

Analytics » Aggregation » Analytical Best Practices

Operations » Packaging Trends

Supply Chain » Raw Materials Tracking

Outsourcing » Development Tips and Trends


Shows » AAPS 2019 PharmSci 360,

Nov. 3–6, San Antonio, TX » CPhI Worldwide, Nov. 5–7,

Frankfurt, Germany

Value-Added » CPhI Worldwide/bioLIVE Preview » AAPS Preview in BioPharm


Sponsored Content eBookBioprocessing Application NotebookA compendium of case studies, application notes, and posters on a range of biopharmaceutical development and manufacturing processes.

NovemberAd Close: October 10

Focus » Scale-Up vs. Scale-Down vs. Scale-Out


Pipeline » Protein Therapeutics

Upstream Processing » Process Modeling

Downstream Processing » What’s New in Downstream Technologies

Manufacturing » Vaccine Development and Manufacturing

Quality/Regulations » Lot Release Testing

Analytics » Bioassay Development


BioBusiness » Intellectual Property



Value-Added » New Tech Showcase (Print) » Free Listing in BioPharm

International’s Knowledge Resources Newsletter (Lead Generation)

DecemberAd Close: November 8

Focus » Building a Biopharma Company


Development » Cell Therapies

Upstream Processing » What’s New in Upstream Technologies

Downstream Processing » Viral Clearance

Manufacturing » Process Monitoring/Controls

Quality/Regulations » Compendial Updates

Analytics » Extractables and Leachables Testing

Operations » Clinical Trial Materials

BioBusiness » Investment Outlook

Outsourcing » Manufacturing Tips and Trends


Value-Added » Corporate Profile in the Corporate

Capabilities Section (Ask your sales representative for details.)

Special Themed eBookBioPharm International’s Regulatory Sourcebook and ReferenceAn updated compilation of regulations, guidances, compendial documents, position papers, and enforcement actions from global regulatory authorities.

CONTACTS



INTERNATIONAL

PublisherMike Tracey 485F US Highway 1 South Suite 210Iselin, NJ 08830USA+1 [email protected]

North AmericaScott VailSales Manager+1 [email protected]

Europe and GlobalUBMHinderton PointLloyd DriveCheshire OaksCheshire, CH65 9HQ, UK

Linda HewittEuropean Sales ManagerTel: 44 (0) 151 353 [email protected]

Stephen ClelandEuropean Sales ExecutiveTel: 44(0) 151 353 [email protected]

SALES

US Editorial OfficeRita PetersEditorial Director485F US Highway 1 SouthSuite 210Iselin, NJ 08830USA+1 [email protected]

Send Press Releases [email protected]

EDITORIAL



INTERNATIONAL

485F US Highway 1 South, Suite 210, Iselin, NJ 08830 +1.732.596.0276 www.biopharminternational.com


BioPharmINTERNATIONAL

January 2018

Volume 31 Number 1

SCIENCE AND FUNDING INJECT EXCITEMENT

INTO BIOPHARMA

ANALYTICS

STABILITY TESTING ENSURES

PROPER PACKAGING

FOR DRUG STORAGE

PEER-REVIEWED

USING DIRECT

TRANSITION ANALYSIS

IN CHROMATOGRAPHY

FLUID HANDLING

SELECTING AND

INSTALLING PERISTALTIC

PUMP TUBING



INTERNATIONAL

March 2018

Volume 31 Number 3

INNOVATION SPARKS BIOLOGIC DRUG APPROVALS

PROCESS MODELING

CHARACTERIZING A

BIOPROCESS WITH ADVANCED

DATA ANALYTICS

PEER-REVIEWED

ENHANCED EXPRESSION

OF GROWTH FACTOR-β

TYPE II RECEPTOR

DOWNSTREAM PROCESSING

EMPLOYING SPECTROSCOPIC

TOOLS IN DOWNSTREAM

PROCESS CONTROL



INTERNATIONAL

April 2018

Volume 31 Number 4

WEARABLE INJECTION DEVICES ADDRESS DELIVERY

CHALLENGES

DOWNSTREAM

PROCESSING

MAKING THE MOVE

TO CONTINUOUS

CHROMATOGRAPHY

PACKAGING

IMPROVING

VISUAL INSPECTION

PROTEIN

CHARACTERIZATION

MULTIPLE VIEWS DELIVER

PROTEIN PARTICLE

CHARACTERIZATION



INTERNATIONAL

Volume 31 Number 6

June 2018


DOWNSTREAM PROCESSING

CHALLENGES IN CELL

HARVESTING PROMPT

ENHANCEMENTS

ANALYTICS

RAPID ADVENTITIOUS AGENT

TESTING REMAINS

A REAL NEED

ENSURING FILL/FINISH QUALITY THROUGH AUTOMATION

UPSTREAM PROCESSING

BIOREACTOR MONITORING:

MORE TO MEASURE THAN

GLUCOSE IN, MAB OUT


BioPharmINTERNATIONAL

May 2018

Volume 31 Number 5

MANAGING UNCERTAINTY IN CONTINUOUS BIOMANUFACTURING

DOWNSTREAM

PROCESSING

PUTTING VIRAL

CLEARANCE CAPABILITIES

TO THE TEST

PEER-

REVIEWED

NIST SPECTROSCOPIC

MEASUREMENT

STANDARDS

PROCESS

MONITORING

LEVERAGING DATA FOR

BETTER BIOPHARMACEUTICAL

PROCESS CONTROL


INTERNATIONAL

February 2018

Volume 31 Number 2

ADVANCES INANALYTICAL

TECHNOLOGIES

DOWNSTREAM

PROCESSING

INDUSTRY ADOPTION OF

SINGLE-USE SYSTEMS

REMAINS LOW

CELL AND GENE THERAPY

MANUFACTURING

FDA FRAMEWORK

SPURS ADVANCED

THERAPIES

FACILITY DESIGN AND

OPERATIONS

DESIGNING A SINGLE-USE

BIOPHARMACEUTICAL

PROCESS



2019 editorial calendarfiles.pharmtech.com/alfresco_images/pharma/2018/10/... · » analytical best...

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