President`s Message

Published by the ISPE San Diego Chapter
Serving Southern California San Diego to Orange County
Editor: Kimberly Syre Email: ksyre@cox.net
Information: Phone 1.949.387.9046 and Fax 1.949.387.9047
NEWSLETTER • Volume 16, No. 3 • www.ispe.org/sandiego
ISPE’s 2007 and 2008 Platinum First Place Award Winner for Excellence and Innovation
In this issue
President’s Message
PAGES 1 & 2
Full Day Risk Based Validation
Class Presentation Descriptions
and Speaker Bios
PAGES 3-7
Save the Date: April 16
Lean Manufacturing and Six
Sigma Meeting at Genentech
PAGE 8
DPR Construction group at the January Social Bowling Event at East Village Tavern + Bowl in San
Diego. Thanks to DPR and other attendees for participating in the Chapter’s food drive. An entire
car load of food was donated to Father Joe’s Villages benefitting needy families in San Diego.
Spring Golf Tournament at
La Costa Announced
PAGES 9-10
Welcome New Chapter
Members
PAGE 11
Oktoberfest Photos/Overview
PAGE 12
Energy Optimization Overview
& Genentech Tour Photos
PAGE 13
January Social Event Photos
PAGE 14
Bioprocessing Class Overview
and Photos
PAGES 15-16
2009 ISPE Event Calendar
PAGE 17
President’s Message
I
by Andy Darragh of Ferguson Pape Baldwin Architects
’d like to thank Marty Becerra who is stepping down after serving on the ISPE San
Diego Board of Directors for over ten years and for being our Treasurer for the past six
years. Thank you Marty! Taking her place will be Stacy Sutton, the Assistant Director of
Infrastructure and Logistics for Althea Technologies. Help me to welcome Stacy.
In November we had another fantastic event at the Genentech NIMO campus in Oceanside.
Thanks to Genentech for the delicious spread of food and beverages they provided along with
guided tours and a beautiful setting for our workshop on energy optimization. Thanks to Mike
Barbera of Project Management Advisors and Carl Hixon of Genentech for organizing this successful event.
I hope that many of you were able to attend the ISPE Annual Meeting in Boca Raton, Florida
in October, where the San Diego Chapter received the Platinum First Place award for the
second year in a row! Thanks to all of you who volunteer your time and attend our events to
make our Chapter so strong. We are really looking forward to hosting the Annual Meeting in
San Diego this year in November. It’s a rare opportunity for our Members to benefit from the
fantastic programs this meeting has to offer without the cost of hotel and airfare. And you can
leave your umbrella at home!
(continued on next page)
President’s Message (continued)
This year has already started out strong with a great turnout
at our January 15 Social Event at the East Village Tavern and
Bowl. We had over 60 attendees for some great bowling, food
and fun. We also made a generous donation of canned food
for the needy. A special thanks to Ashlee Ujifusa, Christy
Pavano and the Membership Committee for all their efforts in
putting this event together.
Sponsorships Available
ISPE
Continuing on our theme of Efficiency: Doing More with Less,
our January 27 event at Biogen Idec included discussion of the
latest in SDG&E rebate programs, air handler and central plant
optimization and conversion of cooling towers to use recycled
water. With water reduction regulations coming to San Diego
soon, this workshop offered some great first-hand knowledge
from an owner’s perspective.
Classroom Training
Lower Production Costs,
Improve Process Efficiency,
Increase Production Quality,
and Meet Regulatory Requirements
In February Biogen Idec hosted another great event. Our next
newsletter will include event photos and an overview of the
meeting.
Philadelphia Classroom Training
5-8 October 2009
Hilton Philadelphia Airport,
Philadelphia, Pennsylvania, USA
In March we are offering our full day education course on RiskBased Validation. This course will consider all facility systems
and provide guidance to creating a validation program that
addresses risk appropriately without unnecessary overkill. This
will be a great overall reference for those involved in systems
design and validation. Read on for more details.
09
www.ISPE.org/philadelphiatraining
As always, we encourage you to attend events and stay
involved. We look forward to seeing you all soon.
Andy
Products, knowledge, and quality
Valin delivers
Validation Equipment Calibrations
two to three-day typical turnaround
Valin is the West’s leading supplier of fluid
handling, measurement, process heating,
filtration, motion control and automation
products for a wide range of bio-pharm and
bio-tech applications.
Call us today: 1-800-774-5630
Visit us at: www.valin.com
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Validator 2000 & Digi Strips
IRTD, HTR, LTR, CTR
RH/CO2 Sensors
Hart/Fluke Meters & Probes
2
Validation and Calibration Services
888-433-MASY (6279)
www.masy.com
Full Day Risk Based Validation Class
Wednesday, March 25, 2009
LOCATION: Biogen Idec Nobel Facility
5200 Research Place (UTC Area), San Diego, CA 92122
8:00 am - 5:00 pm
Sponsors:
Hach Ultra Analytics Inc.
R C M Te c h n o l o g i e s , I n c .
S i e m e n s B u i l d i n g Te c h n o l o g i e s
Program Managers: Dan Cooper
Audrey Prosser, QA Manager, Mentor Corporation (J&J)
Hosted by: Jerry Yaddgo, Facilities Engineer, Biogen Idec
Presenters:
Cleaning Validation
Presented by AB Allen, Sr. Validation Mgr, Amylin Pharmaceuticals ASTM E2500 and FDA’s Draft Process Validation Guidance: A Comparison and Implementation
Presented by Bob Chew, PE, President, Commissioning Agents Inc.
Computer Systems Validation
Presented by Bob Lucchesi, Global Practice Director, RCM Technologies, Inc.
Risk Based Validation, An Auditor’s Perspective
Presented by Melissa Hyatt, Sr. QA Auditor, Amylin Pharmaceuticals
Current Good Process Validation: Practical Tips and Regulatory Trends
Presented by Peter K. Watler, PhD, Principal Consultant & CTO, Hyde Engineering + Consulting, Inc.
USP Water System TOC Validation
Presented by Paul Farrell, TOC Business Development Manager, Hach Ultra Analytical
HVAC Commissioning and Qualification
Presented by Jesse Gillikin, cGMP Validation
Continental Breakfast and Lunch Provided
To Join ISPE On-Line, Visit www.ispe.org
3
Speaker Bios and Class Synopsis
For Risk Based Validation Class on March 25th
Computer Systems Validation
Presented by Bob Lucchesi, Global Practice Director,
RCM Technologies, Inc.
Presenters:
Cleaning Validation
Presented by AB Allen, Sr. Validation Mgr, Amylin
Pharmaceuticals
A high level overview of cleaning validation programs for the pharmaceutical industry will be presented. It will include regulatory
requirements and how to establish a cleaning validation program.
Anne-Barbara Allen is the Sr. Validation Manager for Amylin
Pharmaceuticals. She has been in the pharmaceutical industry for
15 years and prior to that, the aerospace industry for five years.
She previously worked for Gensia Sicor, Genentech and most
recently Hyde Engineering + Consulting. She received her engineering degree from the U.S. Naval Academy.
ASTM E2500 and FDA’s Draft Process Validation Guidance: A
Comparison and Implementation
Presented by Robert Chew, PE, President, Commissioning
Agents Inc.
This presentation will review the new FDA draft Process Validation
Guidance. This guidance describes validation as being comprised
of three major phases over the life of a manufactured drug product or drug substance. The three phases will be discussed. In
addition, the specifics surrounding equipment qualification will be
highlighted, and contrasted with the provisions of ASTM E2500.
Suggestions for improving a qualification program using ASTM
E2500 in light of the new FDA guidance will be discussed.
Robert Chew is President of Commissioning Agents, Inc., a provider of commissioning, validation, and compliance services. He
served on ISPE’s International Board of Directors from 2004 2007. He served on the task team that created ASTM E2500 to
improve how the industry does qualification, and is a member of
the task team updating ISPE’s Commissioning and Qualification
Baseline Guide. He is former chairman of ISPE’s North American
Education Committee, ISPE’s International Education Executive
Committee, and former President of the ISPE Great Lakes Chapter.
He is an official trainer for the ISPE Baseline Commissioning and
Qualification Baseline Guide. He has a BS in Chemical Engineering
from Case Western Reserve University, and is a registered
Professional Engineer.
The FDA and the pharmaceutical industry are now recommending guidelines on the validation of computer systems, software, and processes. Learn how to streamline
validation costs while optimizing validation procedures.
Some topics will include:
• Developing a risk based validation program for your
company
• Categorizing risks and their respective plans
• Reducing testing in a risk based environment
• Developing a “how to” guide
• Developing documentation standards
• Differentiating tasks that will reduce time and effort
• Impacting strategies for maintenance
• Optimizing the Validation Plan
Bob Lucchesi is a seasoned professional with over 30
years of experience in various industries and technologies. He is considered a Subject Matter Expert in Life
Sciences vertical, especially in validation, quality, content
management, and computer systems. The past 19 years
have been dedicated almost exclusively to pharmaceutical and medical device consulting. Before this time, he
was working in the IT technical arena, beginning with
programming and advancing to data base administration and project management. Mr. Lucchesi was also
the President of a highly successful consulting firm in
the nineties, specializing in program management, process improvement, and infrastructure assessments for
the pharmaceutical industry. He is currently the Global
Practice Director in the Life Sciences Division of RCM,
supporting company staff worldwide in validation, quality,
document management, data migration, and overall IT
centric needs.
(continued on next page)
High Purity Liquid Handling
Products for Pharmaceutical &
Biotech Industries
1-800-726-4835
A Foster Wheeler Company
Susanne Lage’ Cost
Vice President,
Chris Ballew
Technical Sales Representative
(805) 906-1533 Cell
cballew@sani-techwest.com
321 Irving Dr., Oxnard, CA 93030
www.sani-techwest.com
4
Business Development
• Process Development
Emeryville, CA
& Scale-Up
Direct: 1.510.594.3003
• Critical Utility Design
sue.cost@biokinc.com
• cGMP Upgrades
www.biokinc.com
• cGMP Facility Design
• Debottlenecking
• Custom Process Equipment
• Commissioning/Qualification/Validation
Speaker Bios and Class Synopsis
For Risk Based Validation Class on March 25th (continued)
Risk Based Validation, An Auditor’s Perspective
Presented by Melissa Hyatt, Sr. QA Auditor, Amylin
Pharmaceuticals
The discussion will address the impact of recent initiatives
and the new Draft Guidance on process validation. Examples
will be given on how to employ PDA Technical Report 42
concepts, FMEA risk analysis and statistical process control
methods to identify and Critical Process Parameters. Stage 3
of the FDA draft guidance will be discussed as well has how to
leverage such data to eliminate the burden of formal validation
studies and revalidation. Some practical tips on performing
mixing studies including what to test, probe placement and
family grouping will be provided. The discussion will address
how to reduce the burden of membrane and chromatography
re-use validation by applying PAT and enhanced statistical
monitoring. Implications from These 21st Century approaches
support better quality, higher compliance, and at the same
time lowering costs.
Melissa will provide insight on how an auditor views Risked
Based Validation. The presentation will discuss documentation and questions that could typically occur during an auditor’s review of risk based validations associated with new
facilities or cleaning. Additionally, it will include a review of
current trends of agency observations related to inadequate
validation activities.
Melissa Hyatt has been working in the pharmaceutical/biotech
industry in for more than 10 years. She started her career in
the Quality Control Analytical and Microbiology Laboratories
of Aventis, then worked as a Validation Consultant at FBN
Validation Associates. Since 2003 she has been a Quality
Auditor at American Pharmaceutical Partners, based in the
great Chicago area and currently at San Diego based Amylin
Pharmaceuticals. Melissa is a cGMP Certified Auditor through
ISPE/GMP Institute and a Certified Quality Auditor through
ASQ. She has audited GXP facilities throughout the US,
Europe, Asia, and South America.
Current Good Process Validation: Practical Tips and
Regulatory Trends
Presented by Peter K. Watler, PhD, Principal Consultant &
CTO, Hyde Engineering + Consulting, Inc.
Peter Watler, PhD is Principal Consultant and Chief
Technology Officer with Hyde Engineering + Consulting. He
has 21 years of GMP biopharmaceutical process experience
with a focus on process design, scale-up, implementation
and facility design, start-up and qualification. He has prepared three license submissions and participated in several
FDA inspections and GMP audits. Dr. Watler was previously
Vice President, Manufacturing at VaxGen, where he led the
design, construction, commissioning and qualification of a
GMP vaccine facility. He was also responsible for managing
supply chain and production operations, led the CMC team
and prepared submissions for government agencies. He previously spent 12 years at Amgen, leading process development,
manufacturing support and overseeing pilot plant operations.
He has led teams for technology transfer, scale-up, pre-clinical
production and process validation for Neupogen®, Stemgen®,
Kepivance® and Infergen®. Dr Walter holds a Bachelor’s
and a Master’s degree in Chemical Engineering from the
University of Toronto and a PhD in Chemical Engineering from
Yamaguchi University, Japan.
The 1990s saw the FDA increase its scrutiny of utility systems, QC laboratories and facility operations. The new millennium has seen a tremendous shift in focus, with regulatory
emphasis on process validation. Initiatives such as Quality by
Design (QbD), Design Space concepts and Process Analytical
Technologies (PAT) are forming the basis of a current Good
Process Validation (cGPV). Process validation now extends
far beyond testing process streams for yield and purity to
include concepts such a Critical Process Parameters, Design
of Experiments (DOE), orthogonal analytical methods and justified acceptance criteria. These advances culminated with the
FDA issuing draft Guidance for Industry, Process Validation:
General Principles and Practices in November 2008. While the
FDA has been advocating more scientific practices as outlined
in the guidance, this is nonetheless the first formal update in
20 years, and will dramatically alter and align industry practices.
VALIDATION
(continued on next page)
COMMISSIONING
Engineering
Architecture
Process Technology
Process Automation
Systems Integration
Construction Management
TRAINING
Nino Borsoni, PMP - Senior Vice President
borsoni@eichleay.com
p. 925.363.3112
f. 925.689.7006
AUDITS
500 Airport Blvd, Suite 100 • Burlingame, CA 94010
Toll-Free (888) 242-0559 • Office (650) 320-1788 • Fax (650) 320-1789
www.propharmagroup.com
5
Startup & Commissioning
Procurement
Project Management
Speaker Bios and Class Synopsis
For Risk Based Validation Class on March 25th (continued)
USP Water System TOC Validation
Presented by Paul Farrell, TOC Business Development
Manager, Hach Ultra Analytical
the system offers advantages because of the levels of purity
found in today’s systems and the lower detection capabilities
of on-line analyzers. It is best to use both methods to ensure
complete understanding of the water systems capabilities in all
situations.
Pharmaceutical companies are in the business of manufacturing drugs or ingredients for drugs, and though drug production
is the final goal it is not the largest volume item they typically
produce. In fact what a great many pharmaceutical facilities
produce the most of in bulk quantities is water and more specifically USP water. The USP water system travels throughout
the facility and affects all the areas in a facility. USP water
is used in manufacturing during the process, in manufacturing after production for cleaning, to make Clean Steam and
in some of the laboratory process for making standards and
reagents.
Validation testing should be conducted under different conditions of the water manufacturing process; these include at rest,
during high and low production and depending on the location
at different times of the year. Seasonal and environmental
changes will effect the feedwater which will test the effectiveness of the pretreatment system to supply quality water.
Paul Farrell is the Global TOC Business Development
Manager at Hach Ultrapure group. Paul is the lead presenter
and coordinator of Hach Ultra’s “Pharmaceutical Water
Monitoring” program in Hach Ultra’s Life Science Users Group
(LSUG) seminars and speaks at industry conferences.
TOC is a required measurement of USP waters. All water systems designed to provide Purified Water, Water For Injection
or Clean Steam need to meet TOC levels described in the
Chapter <643> of the USP Monographs.
Paul began work in the pharmaceutical business in 1980
with Kaye Instruments and has been in the Ultrapure water
business for 17 years. He was National Sales manager for
Thornton from 1992-98. Paul helped to promote the establishment of the USP 23 changes to conductivity by presenting papers on this subject at the 1996 National Conference
of Standards Laboratories (NCSL) and various ISPE
Conferences.
Validation of the USP water systems ability to meet the TOC
specification requires validated and qualified equipment.
Testing is done to ensure performance specified in the water
system User Requirement Specification is met. As part of the
validation document it should clearly define the locations in the
system where sampling will be done.
HVAC Commissioning and Qualification
Presented by Jesse Gillikin, cGMP Validation
The TOC validation testing is accomplished using a combination of on-line and laboratory sampling. Although it is quite
common to see only lab sampling as part of the validation
testing, including on-line for the high purity and USP parts of
The session will provide practical approaches to commissioning and qualification with emphasis on risk-based approach as
described in the ISPE Guidelines, GAMP5, and ASTM E-2500.
Practical boundaries for commissioning and qualification of
the AHUs (air handler units), BMS (Building Management
System), and Facility Qualifications will be discussed.
No Standard
Is Too High
For ABC.
Jesse is a co-founder of cGMP Validation and serves as the
President and CEO. Jesse has over 30 years of experience in
the pharmaceutical industry, including working with more than
300 companies regarding validation and compliance practices.
ALLEGHENY BRADFORD
CORPORATION
Regional Manager - Dori Carlson
Skids • Tanks • Valves • Pumps
Heat Exchangers • Filter Housings
1522 South Ave., Lewis Run, PA 16738
800-542-0650 • www.alleghenybradford.com
Validation Equipment Rentals
Validator 2000s
Digi Dataloggers
RH/CO2 Sensors
Thermocouples
Pressure Transducers
HTR, LTR, CTR & Hart Baths
Validation and Equipment Rentals
6
888-433-MASY (6279)
www.masy.com
Full Day Extended Education Class
Wednesday, March 25, 2009
Risk Based Validation Class
LOCATION: Biogen Idec Nobel Facility
5200 Research Place (UTC Area), San Diego, CA 92122
Program Managers:
Dan Cooper
Audrey Prosser, QA Manager, Mentor Corporation (J&J)
s:
Sponsor tics Inc.
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a Ana es, Inc.
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Hach echnologi
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Hosted by: Jerry Yaddgo, Facilities Engineer, Biogen Idec
8:00 am - 5:00 pm
Continental Breakfast and Lunch Provided
To Join ISPE On-Line, Visit www.ispe.org
Sponsorships are available. Please email ksyre@cox.net to inquire.
REGISTRATION RISK BASED VALIDATION CLASS - March 25, 2009
To register, complete this form with credit card payment and fax it to 949-266-8461 or 949-387-9047.
If paying by check, first fax your registration form then mail your check made payable to:
ISPE SAN DIEGO CHAPTER, 5319 University Dr., Suite 641, Irvine, CA 92612.
Chapter Hotline (800) 869-9621 or (949) 387-9046. Cancellations must be received in writing by March 18, 2009 for refund. After
the cancellation date if you have reserved a space but do not attend, your payment MUST be remitted, however, an alternate person may attend in your
place. If the alternate is not a member, they will need to join.
Receipts for payment and Name Badges will be given at the on-site registration desk.
COST
❑
$225
ISPE Members
❑
$315
NonMembers
ISPE Member:
Chapter Affiliation:
First Name:
Last Name:
CREDIT CARD PAYMENT
Title:
Company:
Address:
Type of Credit Card
Circle One
City:
Name on Card:
State:
Zip:
Credit Card #:
Tel Number:
Exp Date:
Fax Number:
Signature:
E-Mail:
Save the Date
On April 16th the ISPE SD Chapter is planning an evening meeting at Genentech. The topic “Lean Manufacturing and
Six Sigma” is being planned by Carl Hixon of Genentech and Steven Chung of Dynalectric. The speaker is Gary
Higganbotham of Solar Turbines. The presentation will include a presentation of how Genentech is incorporating
Lean Manufacturing and Six Sigma into their operations.
More information will be available soon and will be sent via email.
www.ISPE.org/onlinelearning
®
Life Sciences Group
Life Sciences Group
S T E RNeed
I S ® Knowledge?
S T E for
R I STravel?
Southern California
Southern California
No Budget
800-989-7575
www.steris.com
800-989-7575
www.steris.com
No Problem.
STERIS Corporation
STERIS Corporation
Stacey Betts
ISPE Online Consumables
Learning delivers critical knowledge and
training to you
anywhere, and
Ext.anytime,
23218
at a price tostacey_betts@steris.com
fit your budget.
David J. Spencer
Equipment
Ext. 23178
david_spencer@steris.com
Learn more at www.ISPE.org/onlinelearning or call
Stacey Betts
Consumables
Ext. 23218
stacey_betts@steris.com
David J. Spencer
Equipment
Ext. 23178
david_spencer@steris.com
ISPE Member Services at tel: +1-813-960-2105.
STERIS
®
STERIS Corporation
STERIS
Life Sciences Group
Southern California
800-989-7575
www.steris.com
®
STERIS Corporation
Stacey Betts
Consumables
Ext. 23218
stacey_betts@steris.com
David J. Spencer
Equipment
Ext. 23178
david_spencer@steris.com
Julie Lees
Regional Manager, Southern CA
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Stacey Betts
Consumables
Ext. 23218
stacey_betts@steris.com
David J. Spencer
619.395.3748 cell
Equipment
Ext.julie.lees@hyde-ec.com
23178
www.hyde-ec.com
david_spencer@steris.com
®
STERIS
®
STERIS
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Christy Pavano
STERIS Corporation
Stacey Betts
STERIS Corporation
christy.pavano@crbusa.com
Consumables
Ext. 23218
Phone: 760-496-7091 Cell: 760-685-6232
stacey_betts@steris.com
www.crbusa.com www.crbbuilders.com
David J. Spencer
n QUALIFICATION
CONSULTING n DESIGN n CONSTRUCTION n COMMISSIONING
Equipment
Ext. 23178
david_spencer@steris.com
®
8
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Stacey Betts
Consumables
Ext. 23218
stacey_betts@steris.com
David J. Spencer
Equipment
Ext. 23178
david_spencer@steris.com
ISPE San Diego
&
Los Angeles Chapters
Present
the
4th Annual
Spring Golf Tournament
Friday, May 1, 2009
La Costa Resort and Spa
South Course
http://www.lacosta.com/golf/courses-southx.asp
2100 Costa Del Mar Road, Carlsbad, CA 92009 • 800.854.5000
7:00 am
8:00 am
REGISTRATION
SHOT GUN START
Proper Golf Attire Required
No Metal Spikes
2-Person Best Ball
There is a limit on the number of players
Participation will be based on order paid
Cost Per Player: $175
Price Includes:
Green fee, Cart, Range Balls and Meal at the turn
For Sponsorship Opportunities,
Please contact Albert Marquez
at 760-408-6081
• No handicaps • Callaway format • No door prizes
• No longest drive/closest to the pin • Boxed meal will be included
• Meet in bar after tournament for socializing and a cash bar
Spots can be confirmed once payment is received
Below is a link to our online processing site:
http://event-confirmation.com/ispesd_meetings.htm
Call 888-275-0189 or 949-387-9046 with any questions
ISPE San Diego & Los Angeles Chapters
Present
the
4th Annual
Spring Golf Tournament
Friday, May 1, 2009
La Costa Resort and Spa
South Course
http://www.lacosta.com/golf/courses-southx.asp
2100 Costa Del Mar Road, Carlsbad, CA 92009 • 800.854.5000
7:00 am
8:00 am
REGISTRATION
SHOT GUN START
REGISTRATION ISPE SD/LA Joint Golf Tournament May 1, 2009
To register, complete this form with credit card payment and fax it to 949-266-8461 or 949-387-9047.
If paying by check, send your check made payable to: ISPE SAN DIEGO CHAPTER, 5319 University Dr., Suite 641,
Irvine, CA 92612. Chapter Hotline (800) 869-9621 or (949) 387-9046. Sorry, no refunds for Golf Tournaments.
For an immediate receipt, please use our on-line registration system:
http://event-confirmation.com/ispesd_meetings.htm
❑
$175 Per Player x _______ Players = $_____________
Coordinator Name:
Company:
Address:
City:
State:
Zip:
Phone:
Type of Credit Card
Circle One
Fax:
E-Mail:
Player
Player
Player
Player
CREDIT CARD PAYMENT
Name on Card:
1:
2:
3:
4:
Credit Card #:
Exp Date:
Signature:
WELCOME NEW CHAPTER MEMBERS
October 2008 - February 2009
James Anthony, Director, Enterey, Inc.
Judy Atanackovic, Validation Specialist IV, Gen-Probe
Jason Bakke, Division Mgr Special Projects/Interiors, Turner Construction Company
Erin Bala, Inside Sales Representative, San Diego Fluid System Technologies
Larry Bestmann, Sr Validation Engineer, Beckman-Coulter
Rachel Dean, Student, UC Berkeley
Dan Dorsey, Recruiter, R&D Partners
Hassan Farah, Student, California State University Dominguez Hills
Bruce Firestone, Allergan Inc
Abigail Freeman, Student, Northeastern University
Jon Haigis, Head of Capital Projects, Genzyme
Huilan Han, Student, University of California-Davis
Denise Houchens, Project Manager, Genentech
Ben Huey, Engineer II, Baxter BioScience
Robert Inouye, Principal Engineer, Baxter BioScience
Terry James, Operations Manager, Kinetic Systems Inc
Kavya Katipally, Student, University of California-Davis
Eric Ketelhut, Validation Engineer, Commissioning Agents Inc.
Wan-Chu Kung, Miramar Community College
Karen Leung, Graduate Student, University of California-Davis
Roman Levytskyy, PhD Candidate, San Diego State University
Cliff Lipman, President, Coceri
Jumpei Nagano, Student, University of California-Davis
Noel Nevers, Project Manager, Hyde Engineering + Consulting, Inc.
Stephen Nguyen, Principal Validation Engineer, Abbott Vascular
Stepheni Norton, Global Software Validation Lead, DJO Global
Michael O’Shea, Validation Manager, Genentech, Inc
Heather Palko, Graduate Student, University of California-Davis
Steve Panico, Account Manager, Emcor Service/ Mesa Energy Systems
Tim Pettay, Sr. Validation Engineer, Beckman Coulter
John Pinion, Sr VP, Quality & Compliance, Genentech, Inc
Laura Power, Student, University of California-Davis
Gary Primes, V.P. Operations, PURE Bioscience
Jidong Qu, Manufacturing Engineer, Allergan
Ian Schomer, VP of Corporate Development, 360 Vantage
SethSchreiner, Electronic Control Systems, Inc.
Debbie Stowe, System Admin, Nexgen Pharma
Liban Telahun, Mechanical Engineer, CRB
Kevin Tsui, Quality Engineer, Neutrogena Corp/Johnson & Johnson
Evelyn Wang, Automation Engineer, Genentech Inc
Willie Wells, Student, San Jose State University
Jessica Zittere, QA Validation Specialist, Bayer Tech
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Oktoberfest Overview
by Ashlee Ujifusa of BioTek Systems/ProcessHQ, Inc.
n October 17, 2008 directly following a very informative and interesting bio-processing class, we had Oktoberfest at Yogi’s
in Cardiff. We had 22 people attend, we all enjoyed drinks and delicious appetizers, played pool and then had a small
celebration for Kimberly Syre for her birthday. Yogi’s was a great venue and their management team was so friendly and
accommodating. Thank you to every one who was able to attend - we had a lot of fun! We look forward to the next social event!
ISPE San Diego Chapter Board of Directors
President
Andy Darragh, Vice President, Ferguson Pape Baldwin Architects
Vice President Don Holden, Sr. Electrical Designer, CRB Consulting Engineers
PHONE
EMAIL
(619) 231-0751 adarragh@fpbarch.com
(760) 496-3714 don.holden@crbusa.com
Treasurer
Christy Pavano, West Reg Dir Bus Devel, CRB Engineers/Builders (760) 496-7091 christy.pavano@crbusa.com
Secretary
Daniel Cooper
coop43065@yahoo.com
Director
Steven Chung, Control Systems Engineer, Dynalectric San Diego
(858) 712-4723 schung@dyna-sd.com
Director
Laura Ellery, Account Executive, Siemens Building Technologies
(858) 693-8711 laura.ellery@siemens.com
Director
Mike Fino, Professor, MiraCosta College
(760) 757-2121 mfino@miracosta.edu
Director
Carl Hixon, Senior Engineer, Genentech
(760) 231-2819 cjhixon@gene.com
Director
Tim Price, Process Engineer, X-nth
(858) 597-0555 tprice@x-nth.com
Director
Stacy Sutton, As’t Dir, Infrastructure/Logistics, Althea Technologies (858) 882-0123 ssutton@altheatech.com
Director
Ashlee Ujifusa, Field Sales Representative, ProcessHQ
(760) 730-9376 ashlee@processhq.com
Director
Jerry Yaddgo, Sr. Facilities Engineer, Biogen Idec, Inc.
(858) 401-8062 jerry.yaddgo@biogenidec.com
Past President Edward Domanico, Director of Engineering, Vical Incorporated
(858) 646-1329 edomanico@vical.com
12
Energy Optimization Workshop and Facility Tour of Genentech
by Carl Hixon of Genentech
G
enentech opened their huge doors to us once again on November 6 by hosting a facility tour and workshop. We began in the afternoon with a workshop
on Energy Optimization led by Eric Nyenhuis and Pete Myers of Siemens
Building Technologies. Many companies are realizing the value of energy optimization efforts and our speakers discussed their recent experience with implementing
sophisticated control solutions such as VAVPlus and demand response in order to
help companies save substantial operating costs and meet their sustainability goals.
Christoph Lebl of Genentech gave an overview of the campus facilities before heading out on several guided tours of the utility spine and manufacturing buildings. A
huge spread of food and drinks were served by the Genentech folks on their elegant
café patio for attendees to enjoy before and after their tour. We always appreciate
the hospitality of our member companies and Genentech pulls out all the stops!
Thanks to our sponsors Dynalectric, Veriteq Instruments and Siemens Building
Technologies. And thanks to our Program Managers, Carl Hixon of Genentech and
Mike Barbera of Project Management Advisors for organizing this successful event.
13
January Social Event Photos
Bowling at East Village Tavern + Bowl
High Purity Liquid Handling
Products for Pharmaceutical &
Biotech Industries
1-800-726-4835
Chris Ballew
Technical Sales Representative
(805) 906-1533 Cell
cballew@sani-techwest.com
www.sani-techwest.com
321 Irving Dr., Oxnard, CA 93030
ROD LEAVITT
Leavitt-Pacific Corp.
Representatives
14
1361 High Street
Tel: 510-865-1655
e-mail: rleavitt@leavitt-pacific.com
Alameda, CA 94501
FAX 510-865-0979
web: www.sharpemixers.com
MiraCosta Hands-On Bioprocessing Day
Overview by Mike Fino of MiraCosta College
O
n October 17th, 2008, MiraCosta College hosted a Hands-On Bioprocessing
Day. The event was held at the Biotechnology Training Facility on the
Oceanside campus. The facility was designed by ISPE Members and
was opened for classes in January 2006. The 3,500-square foot facility maintains
over $1-million in state-of-the-art equipment, underscoring the hands-on approach
MiraCosta has taken to train highly qualified technicians for the local biotechnology
industry. Seventeen people participated in the event. The course was modeled after
MiraCosta’s BTEC221 class, Bioprocessing: Cell Culture and Scale-Up, which is part
of a program recognized by the United States Department of Labor as a National
Center of Excellence.
The event was coordinated and led by board member and MiraCosta faculty, Mike
Fino. Nova Biomedical co-sponsored the event and provided valuable reagents
for the analysis of media composition. The agenda for the day featured a mix of
lecture and lab activities focused on the upstream processing activities involved
in the production of a modern biopharmaceutical. Major topics for the lecture portion included an overview of large scale bioprocessing, a review of GMP-compliant
documentation, common expression systems, an introduction to cell culture theory,
aseptic processing, cell nutrient requirements and media design, and an introduction
to process-controlled bioreactors.
The lecture portions were interspersed with hands-on lab activities. The group
was divided into five teams and each group was given a 500-mL spinner flask of
Chinese hamster ovary (CHO) cells recombinant for a human clot-busting blood
protein (tissue plasminogen activator, tPA), media components, and a 3-L bioreactor
to assemble and sterilize. Each group worked against provided standard operating
procedures (SOPs) and batch production records (BPRs). The groups aseptically
sampled their spinner flasks to quantify their viable cell numbers and analyze the
culture media. They then formulated the appropriate volume of media based on the
results of their cell counts. They finished the morning session by assembling, performing initial probe calibrations, and sterilizing their own bioreactors.
After lunch, the groups combined their reactors, cells, and media to start the batch
production of tPA. The reactors were connected to DeltaV process-controlled
bioreactor systems and all the process instrumentation was calibrated. After the
setpoints and limits were established for all the process variables (temperature, pH,
DO, agitation), the systems were placed into fully automated control mode. A final
sample was taken to check the cell counts and process chemistries (pH, glutamine,
glucose, lactate, ammonia, and osmolality).
(continued on next page)
15
MiraCosta Hands-On Bioprocessing Day
Overview by Mike Fino of MiraCosta College (continued)
Documentation was finalized and the attendees left with a complete, hands-on
experience of starting up a bioreactor culture of recombinant mammalian cells.
Though their experience ended with the inoculation of the culture, the MiraCosta
program kept the reactors running to produce more tPA to be used as part of their
Bioprocessing Program and, specifically, the BTEC222 class, Bioprocessing: Large
Scale Purifications, that started the following week. The work of the ISPE Members
ultimately benefitted the students in the program and we are pleased to note that
none of the cultures showed any signs of contamination at the harvest and the
class was able to purify active tPA by the end of the BTEC222 class!
MiraCosta College will host another Hands-On Bioprocessing Day on October 15th,
2009. This second event will focus on downstream processing and will feature a
similar format of lecture and lab where attendees will work through various filtration
and chromatography steps to purify the recombinant protein product expressed in
the prior upstream process.
For more information about the MiraCosta Biotechnology Program, please visit the
program website at www.miracosta.edu/biotech.
16
ISPE Event Calendar
Theme for 2009 ISPE San Diego Chapter
Efficiency: Doing More With Less
ISPE SAN DIEGO
CHAPTER
5319 University Dr., Suite 641
Irvine, CA 92612
Chapter Hot Line:
(800) 869-9621 or
(949) 387-9046
-------------------Fax:
(949) 387-9047 or
(949) 266-8461
For advertising information:
www.ispe.org/SanDiego
_______________________
ISPE is a global, not-for-profit
membership organization that
provides education, training, and
technical publications to
pharmaceutical manufacturing
professionals.
Join ISPE Today For Great
Membership Benefits:
• Member Only Events/Facility Tours
• Discounts to Educational Programs
and Technical Documents
• Subscription to Pharmaceutical
Engineering magazine, with access to
on-line article archives
• Connection to more than 25,000
Members from 90 countries through
an on-line Membership Directory
and More!
PHOTO CREDITS
Cover Photo from fotolia.com:
by photographer Armin Sepp
Other Photos
Christy Pavano, CRB
Ashlee Ujifusa, ProcessHQ
Kimberly Syre, Attention To Detail
17
17-19 March
INTERPHEX, New York, NY
www.interphex.com
25 March
Full Day Risk Based Validation Class
at Biogen Idec
1 April
ISPE San Francisco/Bay Area Vendor Night
South San Francisco Conference Center
7 April
Advanced Cell Culture Short Course
BTEC201, MiraCosta College
More information, including course flyers, can be found at:
www.miracosta.edu/biotech
16 April
Dinner Meeting at Genentech
“Lean Manufacturing & Six Sigma”
1 May
Spring Golf Tournament
La Costa Resort & Spa in Carlsbad
14 May
ISPE LA Chapter Vendor Night
Hilton Costa Mesa
1-4 June
ISPE Washington Conference
18 June
Evening Event
21 July
Padre Game Social Event vs Florida Marlins
August
Vendor Night and Golf Tournament
24 September Full Day Automation Class
15 October
Full Day Bioprocessing Class
at MiraCosta College
15 October
Oktoberfest
8-12 Nov
ISPE Annual Meeting in San Diego!!!
All events subject to change due to availability of venue/speakers.
To Register for Any ISPE SD Meetings:
http://event-confirmation.com/ispesd_meetings.htm
Chapter Web site: www.ispe.org/sandiego
ISPE’s Global Calendar
and Additional ISPE Educational Offerings and Publications:
www.ispe.org