training program 2020 - bcc · scale-up principles program : day 1 seed morning : lectures on gmp...
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Training Program 2020
www.bcc.ch
Tel. +41 79 260 65 44
Biofactory Competence Center SA Passage du Cardinal 13b
1700 Fribourg (CH)
Training is delivered by subject matter experts from both academia and those with many years of industrial experience
Training programs are tailored to all levels of knowledge from new recruits, operators, specialists and senior management
Our courses are :
Training can be adapted to the client
“Critical Training for an Evolving Market”
Interactive lectures given by experts
Hands-on practical in our GMP-like facility
Focused on applications rather than theory
Public Training Courses available
www.bcc.ch
Biofactory Competence Center SA Passage du Cardinal 13b
1700 Fribourg (CH)
Upstream processing Basic Advanced Continuous
Downstream processing
Basic Advanced Continuous
Analitycal courses
Protein characterization Protein quantification PAT Quality Control
Gene Therapy Partner courses
Data Integrity GMP Validation
Other Courses : Cross training for
unemployed Customized courses
General Course information :
Courses take place at the BCC in Fribourg, Switzerland, or be held on site of the client
Course language : English, French or German
Online registration through our website www.bcc.ch or [email protected]
Certification will be handed out to each participant at the end of course
From cells to harvest, Upstream Processing for all
This program may be subject to minor changes
Course information :
3-day course, with 1.5 days hands-on practical
Net price : 2’700 CHF, including lunch
Maximum number of participants : 10
What are the learning outcomes ?
To understand:
The properties of different cell types and when they are used in biopharmaceutical applications
What proteins are and how they are made
How to make cell banks and define seed trains
Functions of bioreactors, when and why they are used and, in particular, the difference between re-usable and
single-use bioreactors
Program :
Day 1
Morning : Lectures on cell types, proteins, cell banking and seed train development Afternoon : Practical 1 : Aseptic techniques, cell transfer and environmental testing
Morning : Lectures on bioreactors, single-use versus stainless-steel, feeding and harvest strategies Afternoon : Practical 2 : Cell counting and metabolite analysis
Morning : Lectures on process monitoring and control strategies, harvesting (separation technologies) and protein analytics Afternoon : Practical 3 : Set-up of bioreactors (STR & single-use), monitoring and control of bioreactors, harvest of cells, cell count & growth rate calculation
Day 2
Day 3
Contact us for dates if you are interested
This program may be subject to minor changes
26th - 28th May 2020
Microbial bioprocessing : principles, practices and
operation
Course information :
3-day course, with 2 days hands-on practical
Net price : 2’700 CHF, including lunch
Maximum number of participants : 8
What are the learning outcomes ?
Participants should be able to:
Create cell banks and seed train
Use various on- and at-line techniques to monitor growth, metabolite and product kinetics
Cultivate secreting and non-secreting cells in different types of bioreactors
Have an in-depth understanding of the structure, function and characterization of
bioreactors
design a bioprocess which optimizes productivity, yield and product recovery through identification of critical process parameters (CPPs)
Program :
Day 1 Morning : Lectures on cell types, proteins, cell banking, seed train Development and introduction to bioreactors Afternoon : Practical : Set-up of bioreactor (STR) and preparation of inoculum
Practical: Bioreactor run : sampling, monitoring and control of critical process parameters, off-line analytics of cell growth and metabolites
Morning : Lectures on bioreactor characterisation, feeding and harvest strategies, processing and monitoring and control strategies Afternoon : Practical : cell harvest, cell breaking, protein recovery determination, data analysis and discussion
Day 2
Day 3
Principles of industrial mammalian cell culture :
an advanced course Contact us for dates if you are interested
This program may be subject to minor changes
Course information : 3-day course, with 2.5 days hands-on practical
Net price : 2’700 CHF, including lunch
Maximum number of participants : 8
What are the learning outcomes ? To understand and be able to use:
GMP principles
Media composition and preparation
Seed-trains and bioprocess development
Batch, fed-batch, perfusion and continuous culture
Micro-carriers
Cell harvest and cell separation techniques
Scale-up principles
Program :
Day 1 Morning : Lectures on GMP principles, medium composition and preparation, seed-train and bioprocess development Afternoon : Practical 1 : Set-up of bioreactor for fed-batch/ perfusion
Morning : Practical 2 : Set-up of bioreactors (STR) for fed-batch operation Afternoon : Practical 3 : Acoustic wave cell separator
Morning : Practical 4 : Scale-up and micro-carriers Afternoon : Data analysis and discussion of practical work
Day 2
Day 3
Continuous and perfusion culture of suspension and adherent mammalian cells
14th - 17th July 2020 10th - 13th November 2020
Morning : Workshop: economic comparison of mAbs versus viral vector production process
This program may be subject to minor changes
Course information :
3.5 days, with 2 days hands-on practical
Net price : 3’000 CHF, including lunch
Maximum number of participants : 8
What are the learning outcomes ?
Participants should be able to:
Culture mammalian cells in different
bioreactor configurations
Design a perfusion process employing suspension cells with cell recycle systems
Design a perfusion process with fixed-bed reactors and micro-carriers
Calculate production kinetics and process economics
Understand the regulatory aspects of continuous bioprocesses
Program :
Day 1 Morning : Lectures on mammalian cell cultivaton and feeding regimes Afternoon : Practical 1 : Installation of fixed-bed-reactor
Morning : Lectures on perfusion cultures and cell separation techniques Afternoon : Practical 2 : Installation of bioreactors (STR) with Acoustic wave cell separator for perfusion cultivation
Morning : Lectures on process integration, analytical techniques for perfusion cultures, regulatory affairs and process economics Afternoon : Practical 3 : Difference of micro-carriers and their binding affinity
Day 2
Day 3
Day 4
Fundamentals of downstream processing
This program may be subject to minor changes
Course information :
3-day course, with 1.5 days hands-on practical
Net price : 2’700 CHF, including lunch
Maximum number of participants : 10
To be able to design a DSP process based on protein properties
To understand the properties of contaminants
To define which resins to use and how to combine them
To be able to pack columns and characterize them
To enable buffer selection
To be able to perform different types of filtration (dead-end, TFF…)
Program :
Day 1
Morning : Lectures on bioprocesses, protein properties and basic chromatography Afternoon : Practical 1 : Introduction to chromatography units - Perform IEX-run with pre-packed column - IEX
Morning : Lectures on Gel filtration chromatography (SEC) and Ion-exchange chromatography (IEX) Afternoon : Practical 2 : Introduction to column packing - Perform column packing manually using a preparative chromatography system
Morning : Lectures on affinity chromatography, filtration, RP phase and mixed mode chromatography , and process examples Afternoon : Practical 3 : Introduction to TFF - Perform a concentration and diafiltration of a protein solution
Day 3
11th - 13th February 2020
What are the learning outcomes ?
Day 2
Industrial chromatography; from resins to packing and
characterization
Course information :
3-day course, with 2.5 days hands-on practical
Net price : 2’700 CHF, including lecture lunch
Maximum number of participants : 8
To be able:
To understand the differences in chromato-graphic resins and to distinguish between their different physical and chemical properties.
To determine the binding capacity of resins.
To perform column packing with different types of resin (IEX, RP), using manual and semi-automated packing.
To run separation processes using self-packed and pre-packed column, and characterize the packing and separation efficiency.
Program :
13th - 15th October 2020
What are the learning outcomes ?
This program may be subject to minor changes
Day 1 Morning : Lectures on DSP process for monoclonal antibodies, physical and chemical properties of chromatographic resins Afternoon : Practical 1, Comparison of different resins and binding capacity
Morning : Practical 2, Manual column packing - pilot scale Afternoon : Practical 3, Pre-packed versus self-packed columns
Morning : Practical 4, Pre-packed versus self-packed columns Afternoon : Data analysis and discussion of practical work
Day 2
Day 3
Protein Characterization
Course information : 3-day course, with 1.5 days hands-on practical
Net price : 2’700 CHF, including lunch
Maximum number of participants : 8
Participants should be able to:
choose the correct method for a specific protein and application
implement a wide range of protein characterization techniques
gain an understanding of the difficulties in quantifying proteins in a wide range of situations
carry out root- cause analysis and solve problems with the methods
understand and master new techniques which can be used for off-line and on-line process analysis, for
example as the basis for IPCs (in-process controls)
Program :
2nd - 4th June 2020 17th - 19th November 2020
What are the learning outcomes ?
Day 1
Morning : Lectures on protein characterization, quantification of proteins, electrophoresis, Western-Blots and SDS-PAGE Afternoon : Practical : SDS-PAGE, Wester Blotting and protein quantification
Morning : Lectures on IEF and 2D electrophoresis, capillary electrophoresis and protein stability Afternoon : Practical : IEF and 2D electrophoresis
Morning : Lectures on HPLC, post-translational modifications and introduction to mass spectrophotometry Afternoon : Practical : Peptide mapping—HPLC
This program may be subject to minor changes
Day 2
Day 3
Source : smart.servier.com
This program may be subject to minor changes
Course information :
Program :
Morning : Practical 2, Continuous centrifugation Afternoon : Practical 3, In-line concentrator
Morning : Practical 4, Breakthrough curves Afternoon : Practical 5, Multi-column chromatography system
Day 2
Day 3
5th- 7th May 2020 1st - 3rd September 2020
3-day course, with 2.5 days hands-on practical
Net price : 2’700 CHF, including lunch
Maximum number of participants : 8
Morning : Lectures : Introduction to continuous downstream processing, QbD, regulation and scale-up possibilities, continuous cell sepraration, filtration and chromatography Afternoon : Practical 1, Acoustic wave cell separator
To understand continuous downstream processing
To understand quality-by-design, regulatory aspects and scale-up of continuous downstream processes
To get hands-on training on continuous cell separation
To get hands-on training on continuous ultrafiltration and diafiltration
To understand theory of multi-column simulated moving bed (SMB) chromatography
To get hands-on training on multi-column SMB with affinity chromatography
To understand and be capable of process integration of continuous technologies into a DSP manufacturing process
What are the learning outcomes ?
Day 1
Continuous DSP
Morning : Protein A run on a continuous chromatography system and process design of continuous bind-elute chromatography Afternoon : Workshop: Method development for a Protein A process
Day 2
Morning : Introduction to continuous Size Exclusion Chromatography Workshop: Method development for a SEC Chromatography Afternoon : SEC run on a simulated moving bed chromatography system
Day 3
This program may be subject to minor changes
Course information :
Morning : Introduction on process integration and hands-on exercise in the lab Afternoon : Summary of the course, questions and answers
Day 4
4-day course, with 2 days hands-on practical
Net price : 3’300 CHF,
including lunch
Maximum number of
participants : 8
Program : Morning : Introduction to continuous chromatography and process integration Afternoon : Scale-up techniques for continuous chromatography, Process design (QbD), regulatory affairs and worshop (scale-up a continuous chromatography step and how to Integrate it into the batch process)
To be able:
To understand the differences between batch and continuous chromatography, pro-cess integration of continuous chromatography in your DSP process
To overcome challenges in regulatory affairs in continuous chromatography
To develop and perform a continuous chromatography run with affinity chromatog-raphy
To develop and perform a continuous chromatography run using SEC and IEX
Scale-up and/or scale-down of continuous chromatography processes
What are the learning outcomes ?
Advanced Continuous Chromatography
30th June - 3rd July 2020 27th - 30th October 2020
Day 1
Introduction to Gene Therapy
This program may be subject to minor changes
Course information :
What are the learning outcomes ?
Participants should be able to:
understand what gene therapy is
understand the types of virus which are used and why
be able to list different available host cell lines and their main applications
define which bioreactor to use at each scale of the seed train
define when to harvest and how to isolate the virus particles
design a purification process
understand the regulatory requirements
Program :
Day 1
Morning : Lectures : Introduction to gene therapy, Viral vectors, Design of a process for the production Afternoon : Practical : Cell growth of adherent cell in T-flask or shake flasks
Morning : Lectures : Bioreactors and feeding regimes for viral vector production, Process monitoring and control, Harvesting and separation Afternoon : Practical : Set-up and operation of a cell factory and iCellis
Morning : Lectures : Purification of viral vectors , Analytical methods during DSP, Regulatory requirements Afternoon : Practical : Chromatography: IEX (ideally Mustang Q and S)
Day 2
Day 3
Morning : Practical : Analytical methods for DSP Day 4
3.5-day course, with 2 days hands-on practical
Net price : 3’300 CHF,
including lunch
Maximum number of
participants : 8
31st March - 3rd April 2020 15th - 18th September 2020 24th - 27th November 2020
Course information : 4-day course, with 2 days
hands-on practical
Net price : 3’300 CHF,
Including lunch
Maximum number of
participants : 8
25th - 28th February 2020 7th - 10th July 2020 1st - 4th December 2020
What are the learning outcomes ?
Participants should be able to:
Define and implement PAT tools
Understand the need for monitoring CPPs
Use a range of on- and at-line quantitative
analytical methods (IPC)
Use multivariate data analysis and DoE
Use Numera for process sampling and automation
Use Lucullus to monitor and control a process
PAT course : Digitalization and automation of cell cultures
In collaboration with
This program may be subject to minor changes
Program :
Morning : Lectures and practical : Numera system and InLine sensors Afternoon : Practical : Measurement and Model calibration
Morning : Lectures and practical : Key Feature Extraction: Multivariate tools for design Afternon : Introduction to DoE (design of experiment) and simulation runs in Lucullus
Day 2
Day 3
Morning : Lectures : Overview of regulatory documents and PAT tools Afternoon : Lectures and Practical : At line and Offline analyser Day 1
Morning : Lectures : Data acquisition and Control strategies Afternoon : Practical : Application of control strategies
Day 4
To understand the principle behind the Solo and FlowVPE
technologies
To define different application areas for the Solo and FlowVPE
To be able to apply both technologies in your up- or down- stream process
What are the learning outcomes ?
On-line dilution-free protein quantification Contact us for dates if you are interested
Course information : 1-day course, with 0.5 day hands-on practical
Net price : 950 CHF, including lunch
Maximum number of participants : 8
Program :
Morning Lectures : Introduction to spectroscopy, introduction and application of SoloVPE and FlowVPE
This program may be subject to minor changes
Afternoon Practical : Comparison study between Spectrophotometer, SoloVPE and FlowVPE during a TFF experiment , data analysis and discussion
Data Integrity
General Courses information :
20th March 2020 What are the learning outcomes ?
To enable interested people in the field of bioprocessing:
To have an overview regarding the regulatory requirements related to data integrity (EU & US)
To know about the general aspects and the concepts related data integrity
To discover the requirements applying to some key elements ("Audit trail", “Electronic Signature, and "Data Migration")
To have an overview of the concepts defined by the GMPs
To integrate the specific aspects related to data integrity in the validation of the computerized sys-tems
Training courses in collaboration with
1-day courses
Net price : 950 CHF, including lunch
Maximum number of participants : 15
Contact us for dates if you are interested
GMP applied to biopharmaceutical processes
What are the learning outcomes ?
To understand why biotech processes are different and how to apply GMP requirements to bio-pharmaceutical manufacturing
To be able to understand the relationships between product, process, and quality aspects in bi-omanufacturing
To improve the quality awareness for biopharmaceutical manufacturing
Validation of biomanufacting processes
Contact us for dates if you are interested What are the learning outcomes ?
To understand the specificities in domain process Validation of Bio-Manufacturing Processes
To define key validation activities for biopharmaceutical process development and manufacturing
To be able to design validation strategies applying to biopharmaceuticals and to successful perform validation activities based on risk approach
A training program to prepare for employment as operator in the biopharmaceutical industry
An INTENSIVE CROSS- TRAINING developed by the BCC to prepare people for working in the biopharmaceutical industry
A GREAT OPPORTUNITY for unemployed people looking for an operator position in biopharmaceutical industry
PROGRAM CONTENT can be adapted to company requirements
The unemployment, invalidity and re-insertion organization finance the training at the BCC and the internship in the company
You are a (bio)pharmaceutical company and you are interested to participate in this program?
Please, contact us at [email protected]
CANDIDATE SELECTION Candidate selection from unemployment,
invalidity and re-insertion register
THEORETICAL COURSES will be provided to build a strong foundation of scientific principles
HANDS-ON PRACTICES practical application of theory under
simulated GMP conditions
INTERNSHIP IN PHARMACEUTICAL INDUSTRY trainees will complete program through an
internship in a (bio)-pharmaceutical company
2 W
EEKS
6 W
EEKS
3 M
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INTER
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GMP
GDP
USP
DSP
KEY SUBJECTS
Training program for the unemployed
More course information will come soon about our :
Quality Control course
www.bcc.ch
Biofactory Competence Center SA Passage du Cardinal 13b
1700 Fribourg (CH)
Are you interested in customized training for your company ?
We offer courses at all levels, tailored to your company’s needs.
Please contact us for further information under: [email protected]
“Critical Training for an Evolving Market”
Discounts available for people registered for more than one course or for
multiple registrations from the same company. Please contact us for more de-tails.
Cancellation Policy :
100% of the cost is payable upon
registration.
50% of this cost is refundable for notifi-cation of cancellation more than one month prior to the delivery of course.
No refund is given for notification of cancellation less than one month prior to the delivery of the course.
In case of incapacity to attend,
registration is transferrable.
BCC reserves the right to cancel the course for operation reasons. People registered for this course will get a voucher to attend a future course.
Travel and Accommodation :
Travel and accommodation are not in-cluded in the course fee. Flights can be booked to either Geneva or Zurich air-port with a direct train connection from both airports to Fribourg.
Accommodation can be booked in the Alpha-Hotel (www.alpha-hotel.ch), which is only a 5 minute walk from the Biofactory Competence Center.
www.bcc.ch
Biofactory Competence Center SA Passage du Cardinal 13b
1700 Fribourg (CH)
More information on our website www.bcc.ch