Training Program 2019

Transcription

1 Biofactory Competence Center SA Passage du Cardinal 13b 1700 Fribourg (CH) Training Program 2019 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 : Interactive lectures given by experts Hands-on practicals in our GMP-like facility Focused on applications rather than theory Training can be adapted to the client Critical Training for an Evolving Market

2 Public Training Courses available Basic cell culture USP Advanced USP Basic DSP Advanced DSP Continuous DSP Protein Characterization Biofactory Competence Center SA Passage du Cardinal 13b 1700 Fribourg (CH) Other Courses : Training programs for the unemployed (ORP) Customized courses for our clients General Course information : Courses take place at the BCC in Fribourg, Switzerland, or customized courses can be held on site of the client Course language can be in English, French or German Registration can be made online on our website or at info@bcc.ch Certification will be handed out to each participant at the end of course

3 Basic cell culture USP course 2 nd - 4 th April rd - 5 th September 2019 Course information : 3-day course, with 1.5 days hands-on practicals Net price : CHF, including lecture notes, lunch, coffee and snacks 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 disposable (single-use) bioreactors Program : Day 1 Day 2 Day 3 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 This program may be subject to minor changes

4 Advanced USP course 25 th - 27 th June 2019 Course information : 3 days, with 2.5 days hands-on practicals Net price : CHF, including lecture notes, lunch, coffee and snacks 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 Day 2 Morning : Practical 2 : Set-up of bioreactors (STR) for fed-batch operation Afternoon : Practical 3 : Acoustic wave cell separator Day 3 Morning : Practical 4 : Scale-up and micro-carriers Afternoon : Data analysis and discussion of practical work This program may be subject to minor changes

5 Basic DSP course 7 th - 9 th May st - 3 rd October 2019 Course information : 3-day course, with 1.5 days hands-on practicals Net price : CHF, including lecture notes, lunch, coffee and snacks Maximum number of participants : 10 What are the learning outcomes? 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 Day 2 Day 3 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 This program may be subject to minor changes

6 Advanced DSP course 16 th - 18 th July 2019 Course information : 3-day course, with 2.5 days hands-on practicals Net price : CHF, including lecture notes, lunch, coffee and snacks Maximum number of participants : 8 What are the learning outcomes? Program : To be able: To understand the differences in chromatographic 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. Day 1 Day 2 Day 3 Morning : Lectures : 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 This program may be subject to minor changes

7 Course information : 3-day course, with 2.5 days hands-on practicals Net price : CHF, including lecture notes, lunch, coffee and snacks Maximum number of participants : 8 What are the learning outcomes? Program : Continuous DSP course 26 th - 28 th March st - 23 rd May th - 17 th October 2019 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 Day 1 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 Day 2 Day 3 Morning : Practical 2, Continuous centrifugation Afternoon : Practical 3, In-line concentrator Morning : Practical 4, Breakthrough curves Afternon : Practical 5, Multi-column chromatography system This program may be subject to minor changes

8 ORP Program A training program to prepare for employment as operator in the biopharmaceutical industry 2 WEEKS 2 WEEKS PRE-SELECTION CANDIDATE SELECTION A GREAT OPPORTUNITY for unemployed people looking for an operator position in biopharmaceutical industry PROGRAM CONTENT can be adapted to company requirements The ORP finances the training at the BCC and the stage in the company Candidate selection from unemployment register SOFT SKILLS ASSESSMENT test candidate s soft skills; define suitability for career in pharmaceutical industry will be provided to build a strong foundation of scientific principles HANDS-ON PRACTICES practical application of theory under simulated GMP conditions 3 MONTHS INTERNSHIP An INTENSIVE CROSS- TRAINING developed by the BCC to prepare people for working in the biopharmaceutical industry THEORETICAL COURSES 6 WEEKS TRAINING (BCC SA) INTERNSHIP IN PHARMACEUTICAL INDUSTRY KEY SUBJECTS trainees will complete program through an internship in a (bio)-pharmaceutical company USP GMP GDP DSP You are a pharmaceutical or biopharmaceutical company and you are interested to participate in this program? Please, contact us at info@bcc.ch.

9 Biofactory Competence Center SA Passage du Cardinal 13b 1700 Fribourg (CH) More course information will come soon about our Protein characterization course Continuous chromatography course You need special training for your company? We can offer courses adapted to your company s need. The training programs are tailored to all levels of knowledge from new recruits, operators, specialists and senior management. Training is given at the BCC site in Fribourg, in the client company s facilities, or a combination of these.

10 Biofactory Competence Center SA Passage du Cardinal 13b 1700 Fribourg (CH) More information on our website Discounts available for people registered for more than one course or for multiple registrations from the same company. Please contact us for more details. Cancellation Policy : 100% of the cost is payable upon registration. 50% of this cost is refundable for notification 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 included in the course fee. Flights can be booked to either Geneva or Zurich airport with a direct train connection from both airports to Fribourg. Accommodation can be booked in the Alpha-Hotel ( which is only a 5 minute walk from the Biofactory Competence Center. Critical Training for an Evolving Market