Hands-on Training Programme for Biopharmaceutical Product Development
The aim of the programme shall be to establish a Skill Development Platform for the development of Human Capital for the benefit of Biopharmaceutical Startups and Biopharmaceutical Industries. The workshop aims at providing specialized training programme towards various aspects of biopharmaceutical product development, with special emphasis on developing monoclonal antibodies. The workshop shall comprise of four parallel modules as sessions -
Module 1: Hands-on-training program on DSP, Purification and Formulation
Module 2: Hands-on-training program on Cell Line development and Upstream Bioprocessing
Module 3: Hands-on-training program on Biophysical characterization of biologics/biosimilar
Module 4: Hands-on-training program on CQA of biologics/biosimilar
Downstream Processing is integral and cost-intensive part of biopharmaceutical development processes involving isolation and purification techniques. Filtration and chromatography are important steps towards isolation and purification of products of interest from cellular material in the biomanufacturing world. The downstream processing techniques affect the economics of manufacturing pharmaceuticals, biopharmaceuticals, vaccines, enzymes, nutraceuticals, etc. Biopharmaceutical industry is challenged by affordable mAb development and technological advances. The module is designed to introduce the principles of downstream techniques employed in the biopharmaceutical industry, its application and recent technological advances, knowledge of the operation, maintenance and troubleshooting of centrifuges, filtration systems, TFF systems and chromatography systems.
Cell line and cell culture processing are the most critical steps for antibody development since both can determine productivity, quality, and cost benefits. There is a wide range of monoclonal antibody based therapies developed using cell culture method. Cell line development starts with expression vector construction and transfection. Cell culture process development starts with cell line generation and selection, followed by process and media optimization in small‐scale systems, including multiwell plates, shake tubes and shaker flasks, and bench‐scale bioreactors. The module will cover cell culture, transfection, cell line development, clone selection and upstream process development using theoretical and experimental strategy.
The characterization of molecular structure, the measurement of molecular properties, and the observation of molecular behaviour presents an enormous challenge to biopharmaceutical production. A wide range of biophysical techniques have been developed to study molecules in crystals, in solution, in cells, and in organisms. These biophysical techniques provide information about the electronic structure, size, shape, dynamics, polarity, and modes of interaction of biological molecules. Biophysical techniques play very important role in understanding protein structure, formulation development and late stage formulation development of protein therapeutics. The module shall help increase your knowledge of the orthogonal technique, understand biophysical data analysis.
In spite of recent advancements in analytical technologies, it remains challenging and time-consuming to fully characterize all variants of mAb products. Although mAb molecular heterogeneities are usually well characterized, their correlations among each other, such as glycosylation and charge heterogeneities, are often less understood. Glycosylation and charge variant understanding is critical for development of protein therapeutics. Ion exchange chromatography, isoelectric focusing, and capillary electrophoresis are commonly employed for charge profiling, whereas liquid chromatography–mass spectrometry (LC–MS) is often limited to structural characterization of isolated charge variants due to its technical complexity. The module shall highlight the understanding of PTMs and glycosylation process, factors affecting glycosylation, fundamentals of mass spectroscopy, capillary electrophoresis and data interpretation.
- Module 1: Hands-on-training program on DSP, Purification and Formulation
- Module 2: Hands-on-training program on Cell Line development and Upstream Bioprocessing
- Module 3: Hands-on-training program on Biophysical characterization of biologics/biosimilar
- Module 4: Hands-on-training program on CQA of biologics/biosimilar
During this workshop, participants shall learn about:
Module 1: Cell Line Development and Upstream Bioprocessing
- Cell Culture Methods
- Shake Flask Culture
- Transfection and clone selection
- Mini-Bioreactors and Bioreactors
- Optimization of Upstream Process Parameters
- Scaleup considerations
Module 2: Critical Quality Attributes of Biologics and Biosimilars
- Critical Quality Attributes (CQA) like Glycosylation, De-amidation, Charge Variant
- Analytical Methods to measure Glycosylation, De-amidation, Charge Variant
- Capillary Electrophoresis
- UPLC and Mass Spectroscopy
Module 3: Biophysical Characterization of Biologics and Biosimilars
- Primary, secondary and tertiary structural analysis
- Protein aggregation principle and method, SE- HPLC
- Introduction to DLS, FTIR and CD Spectroscopy
- Thermal Methods- DSC, ITC
Module 4: Downstream Purification
- Cell harvesting and clarification, protein purification
- Components of a chromatography system and their functions
- Principles and applications for depth filtration
- TFF system and their functions
- Inactivation and removal of viruses
After this workshop, participants shall be able to:
Module 1: Cell Line Development and Upstream Bioprocessing
- Hands on experience of Mammalian Culture
- Transfection and clone selection methods
- Understanding of the concepts and principles of Bioreactor
- Preparation of Bioreactor setup
Module 2: Critical Quality Attributes of Biologics and Biosimilars
- Increase your knowledge of the glycosylation process and charge variant analysis
- Increase the understanding of Mass Spectroscopy and Capillary Electrophoresis
- Understanding Data Interpretations
- Regulations related to glycosylation and charge variant
Module 3: Biophysical Characterization of Biologics and Biosimilars
- Increase your knowledge of the orthogonal technique
- Increase the understanding of Biophysical data analysis
- Understanding Protein Aggregation
- Data Interpretation and correlation
Module 4: Downstream Purification
- Increase your knowledge of the operation, maintenance and troubleshooting of centrifuges, filtration systems, TFF systems and Chromatography systems
- Decrease the number of process excursions and deviations due to operator error
- Reduce the time required to become a subject matter expert in your field
- Become cross-trained in purification procedures to diversify your skill set.
- Interested personnel from the Industry, Startups, Research Institutions, Academic Institutions, Government Bodies, etc. with minimum academic qualification of BTech/MSc degree and atleast 2 years of work experience are eligible to apply for the programme.
- Entry-level to middle-level professionals working in the area of biopharmaceuticals may be well-suited to apply for the programme.
- There is no age limit to apply for the programme.
- Limited seats shall be available for non-working professionals who have completed their post graduate/doctorate degree in areas of science and technology and seeking employment.
- Only those applicants with relevant background or expertise in the area of training are encouraged to apply for the programme.
In order to apply for the programme, please click on the ‘Apply Now’ button. Application form comprises of questions related to participant profile, academic qualifications, work experience, achievements, etc. As part of the application, following is required to be submitted along with the application –
- Date of birth proof ID (Driver’s License, Aadhar, PAN Card, Passport)
- Endorsement Letter from head of department/organization (For working professionals)
- Certificate of highest academic qualification
- Screenshot of online payment
In case of inability to upload document along with the application form, please check the size of the document. The permissible limit of each document is 1 MB. Applicants shall have to select one of four modules in which they would like to receive hands-on training as part of the application form.
A nominal amount of refundable commitment fee of Rs. 1,500/- shall be charged from applicants to ensure only serious candidates applies for this programme. The fees need to be paid as part of the application form using a safe and secure integrated payment gateway. Please mention your bank account details in the application form in order to refund the fees. The amount shall be refund to the non-selected applicants and selected applicants after the training programme. Fees shall not be refunded to the candidate who have confirmed their participation and not attending the programme for the entire duration of the workshop. Processing fees of about 2.6% shall be deducted while refunding the commitment fees to the applicants.
Suitable candidates shall be selected based on eligibility criteria and merit of their application by Selection Committee. Applications found to be incomplete, ineligible and redundant shall not be shortlisted for training. Candidates shall be informed of their selection or non-selection by email. Selected participants shall confirm their participant to BCIL immediately on receipt of email by BCIL. In case the selected candidate shall be unavailable to attend the programme after confirmation, he/she shall inform BCIL immediately. Selected candidates cannot nominate another colleague/friend from their organization.
For the out-station participants, accommodation on twin sharing basis and hospitality arrangements shall be made available for the duration of the programme by ICT, Mumbai. Conveyance shall be provided from the accommodation facility to the programme venue by ICT, Mumbai. Accommodation arrangements shall be made available only for those participants who place a request for it in the application form. Please note that the participant shall make his/her own travel arrangements to reach the venue of the workshop/accommodation from railway station/airport. No travel allowance shall be given to the participants.
Participants shall have to attend the full 5 - day programme. Attendance shall be compulsory for each day of the programme. Certificate of participation shall be awarded to the participants on successful completing the entire duration of the training programme.
You may kindly contact [email protected] or 011-23219064-67 for any further queries regarding the programme.
