Winning Strategies for Tech Transfer
Projects: Key Issues that Affect Successful
Product Manufacture in "New" Facilities
Rocky Mountain ISPE Fall Educational Event
Peter K Watler, PhD
Chief Technology Officer
01OCT2015
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Discussion topics
 Biosimilars
 New manufacturing facilities
 Tech transfer speed and efficiency
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The next wave of biotech
 Emerging biosimilars
 First US Approval
– Sandoz Zarxio (filgrastim) biosimilar to Amgen’s Neupogen
– FDA approved March 2015
– US launch Sept 2015
 Coherus is a US publicly traded company solely focused on
developing the highest quality biosimilars
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Essential elements for successful biosimilar
technology transfer
1. Modern facility design & construction
Efficient
Operation
 Best in class equipment
2. Efficient manufacturing operations
 Streamlined technology transfer
3. Compliant Quality Systems
 Highest quality biosimilars
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Modern
Facility
Design
Compliant
Quality
Systems
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New, modern facilities help biosimilars avoid
inadequacies of aging legacy facilities
 WHO
– Identified Production as the most problematic
area in plant inspections.
 FDA Warning Letters
– “This design is not conducive for controlling
the ---system’s microbial and endotoxin
levels.”
– “The foregoing examples are of serious
CGMP violations…”
Source: AJ van Zyl, WHO, “India Today,
GMP & Validation, 2007,
Biopharm 2010
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CMOs are building expanding with new facilities
 “Fujifilm Diosynth Biotechnologies expands cell culture manufacturing
capacity with addition of two new 2,000L single-use bioreactors”
 “CMC Biologics, Inc., announced today a plan to expand its global
manufacturing capacity by more than 30,000 liters”
 “Rentschler Biotechnologie expands European manufacturing
capabilities with GE Healthcare Life Sciences bioprocess Technologies”
 “DSM celebrates opening of new cGMP facility for biopharmaceutical
manufacturing”
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Successful biosimilar manufacturing
requires rapid fulfillment
 Today’s lengthy fulfillment times are geared to slow paced new drug development
 “Zara can design, produce, and deliver a new garment in a mere 15 days. Such a
pace is unheard-of in the fashion business,” HBR
 Facilities can be built in months, not years
 To be successful in the fast paced biosimilar market, leading suppliers will develop a
rapid fulfillment strategy, days or weeks, not months or years
– Corporate culture
– Operating practices
– Off the shelf
– Inventory levels
– Client-vendor partnerships
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New facilities are highly scaleable, robust
and low cost
“A number of biotech manufacturing breakdowns is raising
questions about industry investment in, and commitment to,
modern production systems” – BioPharm, 2010
Cleanrooms modules built & tested, delivered to site
Assembled in any warehouse space
Flexible ‘ballroom’ layout is easily configured
Hybrid equipment, compliant with current GMPs
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New facilities, next generation equipment
-single use heat exchanger
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New facilities, next generation equipment
-disposable chromatography columns
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Why successful tech transfer matters
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Rapid and efficient technology transfer
to CMOs
 It is not unusual to for CMOs to require >9 months from kick-off
to start of the first GMP batch
 With aggressive planning and careful execution, successful
transfers can be achieved in 3 to 4 months
Product
Tech Transfer
Kick-off
Start 1st GMP
Batch
Elapsed Time
01
AUG
NOV
3.0 months
14
AUG
DEC
3.75 months
14A
APR
JUL
3.25 months
14A2
APR
JUL
3.5 months
20
AUG
NOV
3.0 months
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Keys to success
Leadership, governance, technical dialogue,
a robust mfg process
 Project Leader
 Recipe verifications
 Project Manager
 Sample plans
 Timeline
 Facility fit
 Parallel track activities
 Process walk-through
(equipment, materials,
documents)
 Process description
 Parameter set-points & ranges
 Analytical methods
 Risk assessment (process &
facility)
 Defined CQAs
 Process scale-up (process
model)
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Keys to success
-assemble a good team
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Keys to success
-keep a close eye on things
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Keys to success
-multi-task
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Keys to success
-travel to the site as often as you can
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The importance of a Person-in-Plant - PiP
Trained Engineer
Closely observing operation
-operator experience/knowledge
-operator system check
Historical process data
Clipboard
Calculator
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