WWW.PHARMAMANUFACTURING.COM VOLUME 12, ISSUE 8A

UG

US

T 2

013

WWW.PHARMAMANUFACTURING.COM

WE POLLED PHARMA FANS TO PICK THEIR MVPs (MOST VALUABLE PRODUCTS)

FROM THE INDUSTRY’S TOP TECH TEAMS

McKinsey on Productivity Improvement p.17

Continuous Powder Blending p.26

Deploying Sensors Sensibly p.36

IT Improvements Advance Automation p.40

PM1308_01_Cover2.indd 15 8/6/13 9:40 AM

Departments7. FROM THE EDITOR

Enter the InnovatorsWhether cheaper, faster, safer or easier, innovation puts the “er” in Pharma manufacturing’s progressive improvementBY STEVEN E. KUEHN, EDITOR IN CHIEF

9. DIGITAL INSIGHTSCrowdsourcingNew pharma business model or hipster trend? BY KAREN LANGHAUSER , DIGITAL CONTENT MANAGER

11. UPFRONTCatalent opens new biomanufacturing center; leveraging pharma IT technologies

13. OUTSOURCING EXCELLENCECMOs Share � eir Secrets to SuccessA virtual panel of four CMO thought leaders shares what it takes to be competitive in today’s challenging marketBY STEVE KUEHN, EDITOR IN CHIEF, AND KATIE WEILER, MANAGING EDITOR

17. PROCESS INNOVATION� e Other Path to Productivity ImprovementPharma must transform its productivity, and an emerging set of disruptive innovations promises giant gainsBY ANDREW GONCE, MCKINSEY & COMPANY

48. CLASSIFIEDS

50. THERAPEUTIC DOSEWe Have to Speak the Same Language� ere were a number of misconceptions that held back method development in Pharma for yearsBY EMIL CIURCZAK, CONTRIBUTING EDITOR

Features26. CONTINUOUS POWDER BLENDERS FOR

PHARMACEUTICAL APPLICATIONSIrrespective of the manufacturing route, powder mixing is involved in all manufacturing routes, o� en multiple times in the same processBY SARANG OKA AND FERNANDO MUZZIO, RUTGERS UNIVERSITY

31. METAL RESIDUE: HOW MUCH IS TOO MUCH?To comply with evolving guidelines, drug makers will need analytical and regulatory supportBY DR. ULRICH REICHERT AND DR. NAJIB SEHAT, MERCK MILLIPORE

36. DEPLOYING SMART PROCESS SENSORS SENSIBLYAdvancing sensor technologies improve choices and reliabilityBY AMBER RATCLIFF, HAMILTON COMPANY

40. ADVANCES IN IT IMPROVE PROCESS AUTOMATIONVirtualization, thin clients and other technologies borrowed from IT data centers are the next big thing in process automationBY DAN HEBERT, PE

46. CLEANROOMS REQUIRE SPECIAL EQUIPMENTEnergy-saving technology that both cools and dehu-midi� es the air; self-contained biomanufacturing suites built to order, and goggles you can use up to 25 times are just a few recent o� erings meeting cleanroom needsBY KATIE WEILER, MANAGING EDITOR

Pharmaceutical Manufacturing (USPS number 023-188) is published monthly by Putman Media Inc. (also publishers of Food Processing, Chemical Processing, Control, Control Design, and Plant Services), 555 W. Pierce Road, Suite 301, Itasca, IL 60143 (Phone: 630-467-1300 Fax: 630-467-1179). Periodicals postage paid in Itasca, IL and at additional mailing offi ces. POSTMASTER: send change of address to Pharmaceutical Manufacturing, Post Offi ce Box 3431, Northbrook, IL 60065-3431. SUBSCRIPTIONS: To receive a complimentary subscription go to www.pharmamanufacturing.com. Subscription rate for non-qualifi ed U.S. subscribers is $68/yr. Single copy rate is $15.00. Other international is $200/yr (airmail only). Canada Post International Publications Mail Product Sales Agreement No. 40028661. Canada Mail Distributor Information: Frontier/BWI, PO Box 1051, Fort Erie, Ontario, Canada L2A 5N8.. Copyright ©2013 by Putman Media Inc. All rights reserved. The contents of this publication may not be reproduced in whole or in part without consent of the copyright owner. Reprints are available on a custom basis. For a price quotation contact reprints@putman.net. Subscriptions/Customer Service: (888) 644-1803

36

PHARMACEUTICAL MANUFACTURING • WWW.PHARMAMANUFACTURING.COM AUGUST 2013 5

Cover Feature20. ALL-STAR INNOVATORS 2013

Pharmaceutical engineering’s experts and readers o� er their All-Star technology picksBY STEVEN E. KUEHN, EDITOR-IN-CHIEF

20

INSIDE

PM1308_05_TOC.indd 5 8/6/13 11:31 AM

When it comes to pharmaceutical manufacturing, innovation is nearly synonymous with the collective research and development (R&D) effort put out by the industry. That’s innovation writ large, a strategic impera-tive that has been driving drug development, especially in the decades following the Second World War.

There’s more than one industry observer remarking that innovation just ain’t what it used to be; costs have risen and innovation is stagnating. With the price tag for introducing a successful therapy reaching north of $1 billion and only 30-some new drugs approved by the Food and Drug Administration in 2012, innovation is coming at a higher premium and its progeny not delivering the spectacular returns of just a few years ago. Andrew Jack, corresponding for the Financial Times opines that Pharma innovation is in crisis and posits that Pharma has become a victim of its own success. “To some, the crisis in innovation is the result of the end of a period of ‘low hanging fruit.’ According to that view, the easier work was completed in the latter part of the 20th century, with the discovery of simpler molecules to tackle well-understood diseases,” says Jack.

Perhaps that’s true, but the patent cliff, along with increasing regulatory scrutiny, supply chain complexity and harsh market and competitive forces have also impinged on the ability of drug innovation to deliver the stunning returns of yesteryear.

Perhaps innovation in Pharma’s classical sense has waned and its returns not so “easy” to come by, but in the 10 or so years since the FDA introduced the concept of GMP, innovation is taking on a new meaning and its context is not drug development per se, but productivity improvement. Andrew Gonce of McKinsey & Company covers this supposition thoroughly in “The Other Path to Productivity Improvement” appearing in this issue on page 17. Gonce offers one forehead-banging statistic that reveals quite a bit: “Between 1987 and 2008, for example, labor productivity in the U.S. pharma industry rose by 0.7%, the lowest of any industry and less than a third of the average productivity increase across all industries.” The path for the industry to a better bottom line seems clear, rather than relying primarily on R&D investment to drive financial health and profitability, it’s time we invest in productivity improvements, leveraging partners and

global assets while integrating world-class methods and process technologies to generate competitive advantage and deliver therapies that serve Pharma’s overarching mission: Saving lives.

enter the innovatorsIf the Pharma industry is the “Big Show,” its All-Stars are the innovators, technologies, knowledge leaders, enterprises, technocrats, consultants, financiers, strate-

gists, academicians and many others, who are literally fighting every day to bring new vitality and strength to the industry, starting with the process and manufactur-ing continuum. McKinsey believes injecting the potential of state-of-the-art manufacturing technologies can trim drug production costs by as much as 50%. I recommend you take a few minutes and scan PhM’s cover story “All-Star Innovators 2013” on page 20, which covers standout systems and technologies this publication’s editors, read-ers and contributors found have the potential to deliver both dramatic and incremental gains in productivity.

Ultimately, innovation in the manufacturing space will win the day, and some companies will pursue this with vigor, investing blood (figuratively) and treasure (literally) to be successful. But behind that movement will be another class of innovators — those folks who, through pluck, talent and hard work are introducing change within their reluctant, risk-adverse organizations. The methods, the technologies and the know-how to implement world class productivity gains are available, but the will to institutionalize them in the near term is not so well-established. Those who foster the change and nurture the adoption and integration of these advancements will be the agents of change, the true All-Star Innovators.

steven e. kuehn, editor in Chiefskuehn@putman.net

from the editor

enter the InnovatorsWhether cheaper, faster, safer or easier, innovation puts the “-er” in Pharma manufacturing’s progressive improvement

Pharmaceutical manufacturing • www.Pharmamanufacturing.com august 2013 7

innovation in the manufaCturingsPace will win the day, and some firms Will pursue this With vigor.

PM1308_07_Edit.indd 7 8/6/13 11:32 AM

THOMAS EDISON equated genius as “One percent inspiration and 99 percent perspiration.” Perhaps this is the formula for innovation as well, something that there seems to be no shortage of in the pharmaceuti-cal manufacturing industry of late. � ere’s a distinct movement by many of the industries’ suppliers to intro-duce (some say overdue) innovative technologies that deliver practical, needed e� ciencies into the drug manufacturing continuum. If one is looking closely, especially those oper-ational and manufacturing managers looking for cost and performance gains, it soon becomes apparent that technology suppliers have applied healthy doses of both inspiration and perspiration in pursuit of technolo-gies that Good Manufacturing Prac-tice-based operations and Quality by Design processes are demanding.

Certainly not a comprehensive list, but what follows are technologies and systems introduced within the last 12 months and, based on their relative technical and innovative merits, were chosen to

be on this year’s All-Star Innovators team. Because so many were brought to our attention, we o� er some of the best examples here, but Pharmaceutical Manufacturing’s editors will be highlighting more “All-Star Innovators” online at PharmaManufacturing.com throughout the coming months. � ink something should make the team? Email us and let us know. For now, here are the All-Star Innovators for 2013, ready to help Pharma make the big plays in the market and deliver safer, more e� ective therapies to consumers.

ANALYTICAL AND MONITORING DEVICESAdvantest has been innovating in THz-based spectroscopy space and recently expanded the application coverage of its TAS7500 Series of spec-troscopic imaging systems with two new systems: the TAS7500SU for wide-band coverage, and the TAS7500SL for low-frequency coverage. Advantest is also o� ering a new transmittance polarization analysis module. Accord-

20 AUGUST 2013 PHARMACEUTICAL MANUFACTURING • WWW.PHARMAMANUFACTURING.COM

By Steven E. Kuehn, Editor-in-Chief

WE POLLED PHARMA FANS TO PICK THEIR MVPs (MOST VALUABLE PRODUCTS)

FROM THE INDUSTRY’S TOP TECH TEAMS

PM1308_20_25_CoverStory.indd 20 8/6/13 11:56 AM

Rockwell Automation announced the release of its PharmaSuite v5.0 system for pharmaceutical and biotech production in July. Its goal? Setting new standards for manufacturing execution system (MES) performance in automation, risk management, cost reduction and regulatory compliance. According to the company, the new version delivers a single MES solution with the agility to integrate and streamline production not only across multiple production areas and product lines, but also from line to site level. � e PharmaSuite v5.0 system includes improved integration with production equipment —including premier integration to the Logix control platform — and automated batch processing using the PharmaSuite Recipe Designer. � e system automatically collects data directly from production equipment, provides automation set points, monitors automation events, and integrates process information into the electronic batch record to reduce the risk for human error that can result from manual data collection.

Version 13, the latest version of SIMCA — Umetrics’ so� ware for Multivariate Data Analysis — packs a punch. � is new release, says the company, includes a major overhaul of the interface, usability and graphics. � e intuitive interface reduces the number of mouse-clicks for common actions, and eases the use of SIMCA.

SUPPLY CHAIN TRANSPARANCYIn May, Acsis Inc. announced “Serial-ization in a Box,” a complete turnkey solution that identi� es, applies and captures the data needed to comply with California’s upcoming 2015 e-pedigree mandate. To create a turnkey enterprise serialization solution, Acsis combined its serialization so� ware with material handling, vision and printing equipment. Acsis’ solution

applies and captures serialization data at the unit, bundle, carton and pallet level, so pharmaceutical companies can comply with all domestic and international serialization mandates.

INTERPHEX visitors at Vaisala’s booth were impressed by the simplicity of the company’s CCL100 Cold Chain Logger, and so were the editors at Pharmaceutical Manufacturing. � e simple, compact and disposable device records and monitors time and temperature for vaccines, pharmaceuticals, biologics, and other perishable products during distribution and short-term storage. What’s notable about the single-use CCL100 logger is that it eliminates the need for readers and proprietary so� ware. � e device breaks it down to three simple steps to compliance: 1) place the CCL100 data logger in the product or container; 2) press Start/Mark when it’s time to ship/at each stop; and 3) download the Logger via USB to automatically create a 21 CFR Part 11-compliant PDF report.

Complete Inspection Systems Inc. recently introduced an advanced 2D barcode for absolute product identi� cation and brand protection —no Internet lookup required. According

to the company, the HD Barcode is a revolution in data density, holding up to 703 kilobytes of secure, encrypted information. By incorporating the HD Barcode into the printed materials such as cartons, labels, or containers, pharma manufacturers can incorporate encrypted technology that allows any � rm to positively identify products. � e HD Barcode can be custom-con� gured to provide each manufacturer a unique private version of the code.

WASTE STREAM AND SUSTAINABILITYWhile attending the Global Phar-maceutical Manufacturing Summit, Red Bag Solutions’ medical waste sterilization platform jumped out as an innovator All-Star. It’s the only treat-ment technology available, says the company, that simultaneously grinds and sterilizes medical waste without hazardous chemicals, negative air emissions or odors. � e relatively com-pact unit deploys either site-generated steam or a straightforward ozone regi-men to sterilize the ground-up beakers or similar pharma waste items. In fact, the sterilized waste can be placed directly into the facilities compactor as ordinary municipal trash.

ALL-STAR INNOVATORS 2013

PHARMACEUTICAL MANUFACTURING • WWW.PHARMAMANUFACTURING.COM AUGUST 2013 25

CCL100 COLD CHAIN LOGGER

VAISALA

MEDICAL WASTE STERILIZATION PLATFORMRED BAG SOLUTIONS

PM1308_20_25_CoverStory.indd 25 8/6/13 11:56 AM