A Case Study on

GENENTECH - CAPACITY
PLANNING

Chetana Rohilla : PGP13064

Daisy Khorania : PGP13067
Debaloy Dey : PGP13069
Deepanshu Dalal : PGP13070
Neha Kumari : IPM01042
Pratik Khillare : IPM01046
INTRODUCTION AND BACKGROUND
Introduction: Venture capitalist Robert A. Swanson and Bio-chemist Dr. Herbert W. Boyer founded Genentech in 1976. A
breakthrough called “Recombinant DNA Technology” made them start the company. Facing some skepticism from both
academics and the business world, the duo went ahead with their Ideas.

BUSINESS OVERVIEW

Doubters Proved doubters wrong and discovered a whole new biotech industry.

Recombinant DNA Recombinant DNA drug became the first biotech product approved in the U.S. They
went public in 1980

FDA Approval They received FDA approval for 15 new drugs, which were the gift of DNA
recombinant technology.

Rituxan Its largest product was Rituxan, which had a sales of $1.5 billion.

Herceptin Second largest product was Herceptin, which was for a certain type of breast can cer.

Roche Holding A controlling interest was purchased by Roche Holding Ltd in 1990. This help the
company to spread more geographically.
CLINICAL TRIALS
Phase 1
Test a small group of people
(20 to 80) and evaluate its
safety, safe dosage range and
identify the side effects
Phase 3
Study a large group of people
(1000 to 3000) to confirm
the effectiveness and monitor
side effects and send the
results to FDA for approval.
Phase 2
Study a large group of people
(100 to 300) and determine
the effects and further
evaluate its safety.
Phase 4
Researchers do post-
marketing studies to gather
additional information
regarding the drug’s risk,
benefits and optimal use.
POTENTIAL DEMAND FOR AVASTIN
● In May 2003, the company announced the results of
a phase III trial it had conducted finding that those
who had used Avastin in addition to chemotherapy
had a median survival rate of 20.3 months,
compared to 15.6 months for those who had
received only chemotherapy.
● Genentech received the FDA approval in February
2004.
● Research analysts projected penetration rates
ranging from 5% to 45% depending on the type of
cancer, and the stage of treatment.
 Capacity Overview

CCP1 CCP2 CCP3

● Building the plants with
12,000 liters cell rather
than 25,000 liters cell
would be the most
economical way.
● At present, the focus ● It is suggested to not go
should be laid on fully ahead with the CCP3 at
completing the CCP2 at the moment at least until a
Vacaville. year
 CONCLUSION
● By increasing throughput, they should aim to further enhance the present
procedure.
● Negotiate contracts and agreements with other manufacturers and extra
businesses to establish ties and satisfy the excessive demand.
● Start looking for affordable and advantageous places to establish a new
manufacturing facility. It's crucial to continue seeking for space and to
have the plans for an extra building available.
● By avoiding prolonged revalidation, try to avoid violating FDA
requirements.
● At Vacaville, the CCP2 should be finished to the fullest extent possible.
THANK YOU!