This document outlines training modules offered by BioPilot Training Centre related to biopharmaceutical manufacturing. The modules cover topics such as microbial fermentation, animal cell culture, downstream processing, cleaning and sterilization processes. They include both process-oriented and engineering-oriented components. The training is designed to provide hands-on experience and can be customized based on specific client needs, with standard programs lasting 6 weeks and customized advanced programs covering the same topics over 6 months.

1. BIOPHARMA TRAINING CENTREBIOPHARMA TRAINING CENTRE
BIO-PILOT TRAINING CENTREBIO-PILOT TRAINING CENTRE
@BIOPHARMA TRAINING CENTRE
VADODARA,GUJARAT-390006
Contact :Bhairavi_pandey@yahoo.com
+91-9898640417

2. Module Microbial Fermentation
Process
Oriented
•Seed Development
•Media Optimization
•Shake Flask fermentation
•Scale Up to 5L bench top fermentor
•Scale Up to in-situ sterilization 40 / 125L fermentor
•Autoclaving of fermentor / accessories
•ESIP, FSIP
•Air lines sterilization and Integrity testing of filter
•Sampling / addition lines sterilization
•Inoculation
•Fermentation process parameters control
•Harvest
•CIP
Engineering
Oriented
•Fermentor Functional design
•Detail design (choice of components)
•Automation philosophy: control loops, interlocks and
alarms
•SCADA control
Training Module Details
•Courses are designed to impart the feeling of hands-on experience to the participants.

3. Module Animal Cell Culture
Process
Oriented
•Good Cell culture practices
•Culture establishment (adherent / suspension culture)
•Scale Up to 5L bench top bioreactor
•Autoclaving of bioreactor/ accessories
•Media preparation & filtration
•Culture process parameters control
•Sampling, Harvest and cleaning
•Microcarrier culture
•Wave bioreactor
•Cytotoxicity Assays
Engineering
Oriented
•Bioreactor Functional design
•Detail design (choice of components)
•Automation philosophy: control loops, interlocks and alarms
•SCADA control
Cell Culture Training Module Details

4. Module Downstream Processing
Process
Oriented
•Biomass separation by:
•Centrifugation
•Tangential flow filtration (MF)
•Bio-molecule separation / concentration by :
•Tangential flow filtration (UF)
•Chromatography
•Membrane Chromatography
•Purification by Diafiltration
•Analysis of purity(Gel Electrophoresis / protein assays)
Engineering
Oriented
•TFF Functional design
•Detail design (choice of components)
•Automation philosophy: control loops, interlocks and alarms
•SCADA control
Module Cleaning, Sterilization & Filtration
Process
Oriented
•Heat sterilization cycle development (F0)
•Operation of heat sterilizers (packing / loading etc.)
•Sterilization-In-Place process
•Cleaning-In-Place process
•Pre-Filtration and Sterilizing grade filtration
•Integrity testing of sterilizing grade filters
Engineering
Oriented
•Autoclave / DHS Functional design
•CIP / SIP station Functional design
•Detail design (choice of components)
•Automation philosophy: control loops, interlocks and alarms
•SCADA control
DSP Training Module Details

5. Module Process Oriented Engineering Oriented
Facility &
Utility Design
•Concept of clean room (classification & man /
material movement)
•Gowning practices
•Environmental monitoring
•Plant cleaning and sanitation
•For clean & black utilities: Water / steam / gas
generation and distribution systems functional
design
•Detail design (choice of components)
•HVAC design
•Interconnection piping design
Training Module Details
Facility & Utility Design

6. Training Module Details
Course in Documentation and Regulatory Aspects
Facility
•Validation Master plan
•Room book verification
•Distribution pipelines verification
•Utility system qualification
•HVAC qualification and clean room
validation
Equipment/Instruments
•User Requirement Specification
•Design Qualification
•Quality risk assessment
•Installation Qualification
•Operational Qualification
•Performance Qualification (including media
fill)
Process and Analytical methods
•Process Validation (for main processes such
as fermentation, sterilization,
depyrogenation etc.)
•Introduction to Method validation
Installation
QualificationTest
Plan
PerformanceQualificationTest Plan
Operational QualificationTest
Plan
DesignQualification
RiskAnalysis
Design
Specification
User requirement
Functional design
Implementation
Installation
Qualification
Operational
Qualification
Performance
Qualification
Change Control
Customer

7. Training Program Customization
•Training programs at BioPilot Training Centre can be tailored to meet client specific requirements. Examples of
the customized and standard program are as under:
Program Overview of Biopharma production
Advanced training in Biopharma production and
Engineering
Standard
Week 1 Introduction Month 1 Introduction
Week 2 Microbial Fermentation Month 2 Microbial Fermentation
Week 3 Animal Cell Culture Month 3 Animal Cell Culture
Week 4 Downstream Processing Month 4 Down Stream Processing
Week 5 Cleaning, Sterilization & Filtration
Month 5 Cleaning, Sterilization & Filtration
Week 6
Compilation of results and analysis/
Report writing Month 6 Regulatory Affairs
Duration 6 Weeks 6 Months
Program cGMP requirement for Vaccine Production
Good documentation for Equipment and process
validation
Customize
d
Week 1 Media Preparation and Sterilization Week 1
Establishing documentation
requirements
Week 2
Design of Fermentor, Fermentation
optimization and Scale up
Week 2
Qualification of equipment: fermentor,
filtration system, autoclave
Week 3
Purification of molecule of interest by
primary and secondary processes
Week 3
Validation process: Cleaning,
Sterilization, Fermentation
Duration Customized based on requirement to 3 weeks Customized based on requirement to 3 weeks