Category Archives: Uncategorized

ISPE LA Exhibit Show/GMP Expo

 
Thursday,May 18, 2017

at Brouwerij West
110 West 22nd Street, Warehouse 9, San Pedro, CA 90731

a Craft Brewery  Featuring Belgian Style Beers, Food Trucks
Come get your guidance and experience bioprocessing action!

Register here

Download our event app:
Schedule:  
12:30 – 2:30 pm  Exhibitor Set Up 
 
2:30 – 3:30 pm Networking in Exhibit Area

 

3:30 – 4:30 pm   Technical Session:  Facility Managers Panel Discussion

War Stories from the Plant: Successes and Lessons Learned

Panelists/Speakers:

Michael Dominguez, Sr Facility Maintenance Manager
Prolacta BioScience
Bob Panza, Sr Engineering Specialist, B Braun Medical
Ed Sanderson, Head of Reliability Programs, Shire
Edward Smith, Director, Engineering and Facilities, Teva Irvine
Bill Staley, Princial Engineer / Maintenance Supervisor, Teva, Corona
David Steinberg, Director, Engineering and Facilities, Agensys

Moderator:

Merritt Postma, Director Western Region, Skan US, Inc.

Join us for this unique opportunity to hear from facilities managers and engineers from the areas top pharma companies! Panelists will discuss the perceived problems, remediation and lessons learned on the following topics:
* Shutdown Management
* Reducing Cost of Maintenance / Reliability Programs
* Construction Commissioning and Delivery
* Decommissioning Equipment and Facilities
* Disaster Recovery

System Operational Issues and Solutions
* Water System
* Compressed Air/Gas
* HVAC
* Steam Systems
* Electrical/Emergency Power
* Process Systems
* CIP/SIP Systems
* Safety Systems

4:30 – 5:30 pm
Break in Exhibit Area   
5:30 – 6:30 pm
FDA Technical Session (pending speaker approval)
6:30 – 8:00 pm
Happy Hour Exhibit Show and Student Poster Contest

Implementing Good Manufacturing Practices (cGMPs) – Tour of new Hylands cGMP Manufacturing Facility

When:  Wednesday, April 19, 2017 4:30 – 8:00 pm

Where: Hyland’s 13301 S. Main Street, Los Angeles, CA 90061

Host: Rich Walton, Vice President, Manufacturing, Facilities & Engineering, Hyland’s (Standard Homeopathic)

Register Here

Synopsis of Presentation: The Principles of Implementing Good Manufacturing Practices (cGMP’s) and Validation of FDA Licensed Facilities The presentations will address the necessary cGMP principles associated with the design, construction and commissioning of a FDA licensed facility. Validation will address the implementation of the qualification program, necessary documentation and executions of all qualified systems and equipment.

GMP – current Good Manufacturing Practices (Justin Cantor)
  • What are they
  • Who do they apply to
  • Why are they required
  • Who regulates them
Design/Build for cGMP (Chris Humphrey)
  • When do they start, how is it controlled
  • Design
  • Construction
  • Commissioning – Documentation (TOP’s)
Validation (Charles Heldebrant, PhD)
  • What is it
  • Why is it required – Purpose
  • When does it start on a project
  • Who does it
  • Key elements of validation
    •    Qualification
    •    VMP
    •    SOP’s
    •    IQ, OQ, PQ protocols
    •    Executions
    •    Final reports / stability lots
    •    BLA License
About the Facility Tour:
Hyland‘s has constructed a new cGMP manufacturing facility in the heart of Los Angeles. This tour is an opportunity to view the facility prior to start-up of full-scale operations. The facility is capable of concurrent production of different products, including high volume operations for manufacturing bulk tablets, bulk liquids, intermediate powders, intermediate liquids and packaging bulk tablets and bulk liquids. The facility includes controlled manufacturing, manufacturing support, warehouse, offices, lab, mechanical, and support areas.
Speakers:
Justin Cantor, Director, PSC Biotech
Charles Heldebrant, PhD, Chief Scientific Officer, PSC Biotech
Chris Humphrey, Core Team Leader ,CRB
Schedule:
4:30 – 5:30 pm
Registration, Refreshments and Networking
5:30 – 6:30 pm
Facility Tour
6:30 – 8:00 pm
Presentations: The Principles of Implementing Good Manufacturing Practices (cGMP’s) and Validation of FDA Licensed Facilities
  • GMP – current Good Manufacturing Practices
  • Design/Build for cGMP
  • Validation
About the Presenters:
Justin Cantor is a Director at PSC Biotech. He was previously the Associate Director of Engineering and has held several positions in Engineering, Maintenance and Manufacturing at Gilead Sciences. Prior to his 12 year career at Gilead, he was a Production Supervisor at Alpha Therapeutics and was a Contract Manufacturing Associate and Clinical Manufacturing Associate at Genentech.

Justin has a MS in Pharmaceutical Manufacturing from Stevens Institute of Technology and a BS in Mechanical Engineering from Michigan State University. He also serves on the ISPE Los Angeles Board of Directors as Vice President.

 
Chris Humphrey is the Core Team Leader for CRB’s San Diego office. He has 17 years of engineering and project management experience throughout the Southern California life science industry. He works with CRB’s engineers, architects and construction professionals to deliver design, construction and consulting solutions that achieve successes for their life sciences and advanced technology clients. Chris earned his BS in Chemical Engineering from UC-Davis.
Charles Heldebrant, PhD is the Chief Scientific Officer at PSC. He has 28+ years of experience with Alpha Therapeutic Corporation (formerly Abbott Scientific Products Division) and 4+ years of experience with National Genetics Institute/LabCorp. He has extensive experience in biological and pharmaceutical product development, regulatory affairs, quality systems, process design, equipment and process validation, analytical methods validation and computer validations. He has audited and worked with foreign and US development partners to evaluate API and final drug product, process and facilities and has worked to help development partners achieve cGMP compliance. He has experience in nucleic acid based diagnostics and in the operation of 24/7 facilities.  He was also a science consultant for an animated science program for pre-school children

ISPE LA Executive Night 11/30/16 “Current State and Challenges of the Pharmaceutical Industry”

Featuring Executives
from Agensys and McGuff Pharmaceuticals
  

Wednesday, November 30, 2016

4:30 – 8:30 pm
Speakers: 
Damon Jones, VP and Director of Operations, McGuff Pharmaceuticals, Inc.
Gary Welch, Vice President of Technical Operations, Agensys, Inc.
Schedule

4:30 – 5:30 pm      Registration and Networking with Los Angeles cGMP pharma manufacturing community,  bring colleagues with you

5:30 – 6:30 pm       Dinner

6:30 – 8:30 pm       Presentations and Q& A
Location:    
University Club of Pasadena

175 N. Oakland Ave., Pasadena, CA  91101  (626) 793-5157

About the Speakers
Damon Jones, VP and Director of Operations
McGuff Pharmaceuticals, Inc.
 

Topic of Talk:

Challenges and the Future of Compounding Pharmacy
The McGuff, Inc. Experience and Vision 
This session will include McGuff Pharmaceuticals history, the evolution of McGuff Compounding Pharmacy Services Inc. (CPS), and McGuff Pharmaceuticals, Inc. (MPI), and plans to continue with 503A operation (Compounding Pharmacy under patient Rx). The launch of a new facility to expand commercial and 503B (“Outsourcing Facility”) capabilities to support clinical and commercial scale aseptically filled injectable drugs will also be discussed.
Damon Jones is the Vice President and Director of Operations at McGuff Pharmaceuticals, Inc. As an Operations and Manufacturing professional, he has more than 30 years of technical and managerial experience in the Medical Device and Pharmaceutical industries. Damon has direct experience in functions including managing all operational functions of device and pharmaceutical manufacturing, Microbiology and Chemistry, R&D, and corporate wide Operations and Quality Management systems.
He holds a BS Degree in Microbiology (Chemistry minor) and a Masters Degree in Business Administration. Additional certifications include Certified Quality Engineer (CQE) from the American Society for Quality.
Damon’s skills have been utilized by various companies including OrthoDiagnostics (a Johnson and Johnson Co.), Xenotech Laboratories, Inc., Medtronic, Inc., McGuff Pharmaceuticals, Inc. and others. Serving as Vice President to DEG Consulting in Southern California, Damon has helped varied clients achieve ISO and FDA compliance. In addition to his role at McGuff Pharmaceuticals, Inc., he continues to serve as Vice President to DEG Consulting and Quality Systems Advisor to McGuff CPS, Inc.
Gary Welch, Vice President of Technical Operations at Agensys, Inc.
Gary has over 24 years experience in biotechnology manufacturing. He has led organizations responsible for Engineering, Process and Analytical Development and Manufacturing. His experience includes the development and production of monoclonal antibodies, ADC’s, dual specific antibodies, enzymes and other recombinant proteins from both mammalian and microbial expression systems.
Gary leads the CMC functions at Agensys, which includes cell line, upstream, downstream, and ADC process development, formulation and analytical development, manufacturing of drug substance and drug product for pre-clinical and clinical use. In addition, he oversees engineering, facilities management, EH&S, and supply chain management.
Agensys, Inc., an affiliate of Astellas Pharma Inc., specializes in oncology biotherapeutic discovery and development.
He was previously the Director of Operations/Plant Manager at AbbVie in Worcester, MA. He was also the Director of Process Sciences, Director of Production and Process Engineering Manager for Abbott.
He has a BS in Chemical Engineering from Northeastern University, a MS in Chemical Engineering from Worcester Polytechnic Institute and a MBA in Finance from NYU.
Cost: 
$75 ISPE Members
$95 Non-members
$30 Students/Government
$50 Young Professionals
$500 Event Sponsor (includes table top, your logo on promotions, recognition at the event and 2 admissions)

ISPE LA Golf Tournament 10/27

The annual ISPE Greater Los Angeles golf tournament will be Thursday, October 27 at Coyote Hills Golf Course in Fullerton, CA


18th Annual Golf Tournament
October 27, 2016
Coyote Hills Golf Course
1440 E. Bastanchury Road
Fullerton, CA 92835
Event Chair: Tom Golden 
Schedule:
  • 10:30 am Registration
  • 12:00 pm  Shot Gun Start
  • Awards Banquet To Follow
Price includes 18 holes of golf, boxed lunch, golf cart and banquet
Longest Drive and Closest-To-The-Pin
Lots of Prizes and Lots of Fun!
Dedicated Hole Sponsors:
Your sponsorship includes a table and 2 chairs.  We encourage all sponsors to have a fun theme at their hole.
Sign Sponsors:
Your sign at a hole (does not include participation at the hole).
Shade:
We encourage you to bring your own shade (the course does not have any canopies or umbrellas available).

Note:  Electricity is not available. No glass on the course. Please let Kimberly Syre know what the gameplan is for your hole (ksyre@cox.net).

Costs:
$1,250 Foursome + Drink Sponsor
$1,100 Foursome + BYOB Sponsor
$950 Foursome + Dedicated Hole Sponsor
$800 Foursome + Sign Sponsor
$700 Foursome
$175 Per Player (indicate number of players)
$550 Drink Sponsor (assorted cans of chilled beer)
$400 BYOB Sponsor (you bring your own beer)
$250 Dedicated Hole Sponsor
$100 Sign Sponsor
We need door prizes, golf balls and other give aways
Rules & Regs
No Metal Spikes
Collared Shirts for Men
* No T-Shirts, Tank Tops or Jeans
No Short Shorts
* 4 Person Scramble

Course Overview:
Designed by Cal Olson and PGA Tour Legend Payne Stewart, this beautiful and challenging course utilizes
its natural surroundings, sharing nearly 250 acres with flowing streams and wildlife. Each cart is equipped with a state-of-the-art Global Positioning System to help ensure you thoroughly enjoy your journey on this scenic course.  Features Displayed on In-Cart Color Video Screen include:
* Live Tournament Leaderboard
* Electronic Scoring
* Pro Tips
* Distance / Yardage
* Printed Scorecards
* Hole & Green Overviews
* Customized Sponsor Advertising Opportunities
* Hazard & Landmark Locations
* Weather & Safety Messaging
* Pace of Play Timer
* Current Pin Placement
* Golf Shop Communication
Need Some Instructions Before the Tournament?
Coyote Hills offers lessons. If interested, please email:

HVAC System Design & Operation: Best Practices in Energy Efficiency for cGMP Facilities

Coming soon: ISPE LA Golf Tournament 10/27 at Coyote Hills, Fullerton, CA

ISPE Extended Learning Program

Wednesday, September 28, 2016
Noon – 6:00 pm
  • Implementing Energy Savings in a cGMP Compliant Environment
  • Alternatives to ACH for Cleanroom Design
  • Measuring Effectiveness of Ventilation
  • Air Change Rate Reduction
  • Advanced Control Strategies
  • Top 10 HVAC Misconceptions
  • Hot Topics – Identify Problem Areas BEFORE They Arise

Register Here

Two locations:

1. Amgen
B24 Conference Center
One Amgen Center Dr.

Thousand Oaks, CA 91320

2. Avid Bioservices, Inc.
14282 Franklin Avenue
Tustin, CA 92780
Schedule:

12:00 – 1:00 pm      Registration and Networking with Light Lunch

1:00 – 5:15 pm      Presentation

5:15 – 5:30 pm      Q&A

5:30 – 6:00 pm        Networking / Refreshments

Speaker:  
Norman Goldschmidt, Principal, Vice President, Engineering, Genesis Engineers, Inc.
Norman Goldschmidt is the Vice President and Principal of Genesis Engineers in Plymouth Meeting, PA. Genesis is a consulting A&E firm, specializing in innovative, energy efficient designs for BioPharmaceutical clients.
Norman has over 25 years of experience in conceiving, designing and delivering efficient facilities and processes.
Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market – from R&D through Manufacturing – for Pharmaceuticals, Biologics and Medical Devices.
Mr. Goldschmidt studied Mechanical Engineering at the University of Buffalo and Engineering Management at the State University of New York. He holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) US TAG Delegate and US Expert Delegate to ISO 14644 WG 13 on Energy Efficiency in Cleanrooms and ISO 14644 WG 4 on the Design and Construction of Cleanrooms. Norman provides consulting support to Genesis’ many clients as well as the NIH and NSF.
Norman was also the Lead Author of the ISPE Good Practice Guide for HVAC as well as an author of the new ISPE Baseline Guides for Biopharmaceutical Facilities, Oral Solid Dosage Products, Sterile Products, and Laboratories. He is also an Adjunct Professor at the New Jersey Institute of Technology, US instructor for ISPE training class “HVAC and Environmental Control” and trainer for NSF, ISPE, ASHRAE and Regulatory Agencies.
Registration Fees:
ISPE Members – $95
Free for Amgen or Avid Employees (first 15 employees)
ISPE Non-members – $135

Students and Government – $30

Additional Amgen and Avid employees (after 1st 15) – $30
ISPE Young Professional (YP) Member- $50
Event Sponsor – $500 (includes table top and two attendees)

Fingerprinting Biosimilars

Wednesday, August 17, 2016

Location: Agensys, Inc.

1800 Stewart Street, Santa Monica, CA   

Host:    David Steinberg, Director, Engineering & Facilities, Agensys, Inc. 

Program Managers:          Justin Cantor, Director, PSC Biotech

                                             Paul Crissman, Principal, Biotechnical Solutions

Speaker:                              Dr. Fiona Greer, SGS Life Sciences

Schedule: 

5:45 – 6:30 pm      Registration and Networking Reception with Appetizers

6:30 – 7:30 pm      Program

7:30 – 8:00 pm      Q&A and Networking

Synopsis:

Biosimilar development requires initial comprehensive characterization of the target molecule to determine the exact structure, post-translational modifications and variability of quality attributes to establish the Quality Target Product Profile (QTTP). The engineered biosimilar should match this profile.

For regulatory approval, comparative data for the biosimilar side-by-side with the originator is required. Initially this includes both structural and functional activities.

Analytical strategies for primary and higher order structure determination will be discussed particularly for antibodies where their size and complexity requires LC/MS/MS approaches. Appropriate orthogonal analytical techniques which address regulatory requirements for “finger-print like” assessment, both conventional and emerging technologies, will be reviewed.

Speaker Bio:

Dr Fiona Greer was a founding Director of M-Scan (Mass Spectrometry Consultants and Analysts), contract analytical laboratories specializing in  biopharmaceutical characterization. Following acquisition in 2010, she is now Global Director, Biopharma Services Development, SGS Life Sciences.

Following a Ph.D. in Protein Biochemistry from Aberdeen University (1984) she joined M-Scan to establish and direct biologics characterization services. Here, she pioneered and applied new developments in Mass Spectrometry for structural analysis and sequencing of proteins and carbohydrates resulting in numerous publications and patents. She was instrumental in expansion of the group, establishing a US facility where she was appointed VP.

With over 35 years experience in glycoprotein analysis using mass spectrometry and other instrumental techniques, she has been involved with a diverse range of biotechnology products, both novel and biosimilar and consults to companies throughout the world. She is regularly invited to give presentations and workshops at international meetings. In 2016 she was named in the Medicine Makers “Power List – Top 100 influencers”.

Free for Agensys Employees: Please register prior for the event so we have enough food for the group and can prepare name badges.

________$60 ISPE Members

________$85 NonMembers

________$25 Students and Government (and additional Agensys employees)

________$40 ISPE Young Professional (YP) Member

________Free for 1st 15 Agensys Employees

________$500 Event Sponsor: Sponsors receive a 6′ exhibit table and two admissions to the meeting.

4/5/16 Automated Cleaning, Design for CIP and Cleaning Validation

Tuesday, April 5, 2016

Location: Baxalta Inc Continue reading

Benefits of ISPE Membership

 

There is a great NEW reason to join ISPE today. But you must act now to take advantage of it. We’ve created a custom-designed DOUBLE-BONUS package specifically for professionals like you, which brings you all of ISPE’s current membership benefits plus TWO MORE:
Continue reading

Aseptic Project Review & Tour of Amgen’s B20 Nested Syringe and Vial Line

 

Tuesday, March 1, 2016
3:00 – 7:00 pm (Speakers and tours begin at 4:00 pm)

Continue reading

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