1. POSTER TEMPLATES BY:
www.POSTERPRESENTATIONS.co
m
PT Bio Farma
Internship Objective
Regulatory Agency of pharmaceutical
industry is moving toward the implementation
of Quality by Design. As a leading vaccine
manufacturer, Bio Farma, encouraged by the
WHO, want to implement the concept of
Quality by Design (QbD) for their products.
Project Integration Manager, Erman Tritama,
assigned me the task to create a road map of
the implementation of Quality by Design for
one of the new vaccine currently in the product
development phase. I observed the vaccine
production at laboratory scale under the direct
supervision of Novi Astriati and Yusuf Sofyan.
Tasks Completed
1. t.
Background of Internship Project
A world-class vaccine manufacturer that has
obtained World Health Organization Pre-
Qualified status. Other products are antisera
and diagnostic kit. Currently spreading the
product portfolio by pursuing biosimilar and
stem cells.
Organizational Structure
Professional Activities
Acknowledgement
Special thanks to Jennifer Ton who taught me
the Quality by Design, and Parviz Shamlou who
taught me the principles of scaling up. Those
are priceless lectures that helped me during my
internship. Thanks also to Angela Cossey for
your help before and after the internship.
Thank you to Erman Tritama, Adriansjah Azhari,
Novi Astriati, Yusuf Sofyan and all other
research and product development staffs.
What an enjoyable summer experience.
1. Presented Scale-up principles to the research
and product development staffs
2. Developed the QbD for one of the new vaccine
projects
3. Presented Design of Experiment to research and
product development staffs of bacteria-based
vaccines
4. Created draft of Standard Operating Procedures
on how to implement the Quality by Design
5. Presented Quality by Design and Design of
Experiment to production staffs
6. Presented Case Study of Quality by Design and
Design of Experiments to Research and Product
Development Senior Manager and product
development staffs of viral-based vaccines
1. Meeting with potential supplier of bacteria-
testing device
2. Joined the development team during a small
bioreactor trial for a week. Networking with the
application specialists.
3. Networking with people from other departments
4. Followed an internal audit of the pilot-scale
facility by the company consultant, a former
WHO auditor
5. Attended the National Vaccine Research Forum
organized by PT Bio Farma
6. Mentoring session with the Project Integration
Manager of Product Development and
Research and Product Development Senior
Manager
Memorable Presentation
PT Bio Farma is owned by the government
of Indonesia. The company recently
celebrated its 125 years anniversary. As a
fully integrated company, PT Bio Farma has
its own research and development
department, animal breeding site, media
production, vaccine manufacturing site, and
marketing capability.
Lesson Learned
There are so much things to learn in little time. I observed how research and development is
conducted in a cGMP-based company. I also studied a lot of industrial equipment and saw
how the company implement the regulatory requirements. Finally, the best lesson is realizing
the importance of teamwork at the workplace and good leadership style needed to manage the
interdisciplinary team.
Reference
http://www.biofarma.co.id/?page_id=15172&lang=en#all/1/list
Planning, Research and
Development Director
Planning and Production
Control Senior Manager
Quality Control Senior
Manager
Animal Laboratory
Senior Manager
Surveillance and Clinical
Trial Senior Manager
Research Senior
Manager
Development Senior
Manager

2. POSTER TEMPLATES BY:
www.POSTERPRESENTATIONS.co
m
Planning, Research and
Development Director
Planning and Production
Control Senior Manager
Quality Control Senior
Manager
Animal Laboratory
Senior Manager
Surveillance and Clinical
Trial Senior Manager
Research Senior
Manager
Development Senior
Manager