CCDWC 2017 Day 1
08:00 Registration Opens
08:55
Conference doors open
09:00
Opening and Welcome from Terrapinn
09:05
Chair's opening remarks
Opening Plenary Sessions: New developments for Cell Culture and Downstream Processing in 2017
09:15
Keynote: Converging technologies driving innovation in Biomanufacturing
- Further integration of upstream, downstream, formulation development and analytics
- Increasing the understanding on how the process defines the product
- Process intensification will be key
09:40
Keynote: Regulatory and development aspects of advanced therapy medicinal products (ATMPs)
- Licensed ATMP in EU and products under hospital exemption
- Product classes and variety
- Quality and manufacturing issues
- Clinical data
- Future developments
10:05
Chromatographic processes for the purification of proteins and peptides to the market
- Polymer reactions and reaction-separation processes based on continuous chromatography
- Biomolecules with specific focus on therapeutic proteins and monoclonal antibodies
- Development of new concepts for the downstream processing of biomaterials
10:30
Keynote Q&A session
10:45 Networking Break
11:45
Plenary Roundtable Discussion Session
8 senior level tables hosted by thought leaders on key challenges and opportunities in the manufacture of biologics. Participants are invited to join in the small-group discussions on a topic of primary importance to them.
TABLE 2: Cell based bioassays for biopharmaceuticals - make or buy?
Dr Manfred Papaspyrou, Head Marketing & Sales, Glycotope Biotechnology GmbH
TABLE 3: Drug products - formulation, fill and finish
Moderator:
Prof. Tudor Arvinte, President and Chief Executive Officer, Therapeomic Inc
TABLE 4: Heterogeneity and clonal cell populations
TABLE 5: Perfusion culture - challenges and solutions
TABLE 6: Advanced therapies - manufacture and scale up
12:45
Speed Networking
A fun, exciting way to make a lot of initial connections (in a very different environment from the standard business networking meetings).
13:00 Networking Lunch
Regulatory and IP aspects of CMC and developability
Upstream - Manufacture and logistics of next generation therapeutics
Downstream - Purification approaches and platforms for next generation therapeutics
Formulation
14:30
Manufacturing monoclonal antibodies in plants – the future is green!
- Plant biotechnologies available for molecular pharming
- Advantages of plant manufacturing platforms
- Development of a GMP process to a first in human clinical trial
- Future potential of plants for biologics
14:30
Manufacture of viral vectors for gene therapy
- Innovation in viral vector development, generation and production
- Intensification of rAAV manufacturing
- Improved optimisation and quality of bacolovirus
14:30
Magnetic beads for purification for antibodies
- A promising technology in development born out of collaboration
- Magnetic beads have high potential for loading, so can be used for purification
- Overview of results and data
14:30
Adsorption to filter membranes: relevance for administration and manufacturing
- Filtratration is an important processing step, which a formulated biologic can experience at different stages throughout its lifetime (manufacturing of fully-formulated DS and fill and finish for DP, administration in a clinical setting)
- Adsorption to filter membranes is one of the common incompatibilities during DP administration in a clinical setting. Finding correlations can help in simplifying compatibility studies.
- Adsorption to filter membranes during sterile filtration is one of the critical process attributes. Down scale models will be discussed.
14:50
Cellular Immunotherapy: product, process and patents
- Evidence for the clinical efficacy of CAR-T immunotherapies is building, and systematic assessments have shown this
- The complex patent landscape for regenerative therapies has resulted from a shift away from patenting the therapeutic entity towards patents of processes and components thereof
- Certain critical aspects of the manufacturing processes for immunotherapies remain largely unexplored, in particular the impact and measurement of leachables and extractables
14:50
Defining a robust cell culture process control strategy for biologics launch processes – the application and limitations of small-scale and large-scale data
- Process Control strategy prerequisites – CQA determination and Process Risk assessment (FMEA)
- SSM Qualification
- Process Characterization Studies : from De-risking to PAR studies – PAR calculation for critical parameters, NOR definition
14:50
Challenges with downstream process development for non-antibody non-platform molecules
- Improving HCP reduction
- Intermediate Hold times
- Scalability and Manufacturability
14:50
Aggregation analysis at high and low protein concentrations
- Aggregation of proteins may occur by a number of different mechanisms, which can lead to a range of aggregate types
- Using a range of analytical techniques, the formation of protein aggregates by various mechanism has been assessed at low and where possible, at moderate to high protein concentrations
- The effect of sugars on protein stability will also be discussed
Downstream - Advances in chromatography and novel purification methods
15:10
The importance of raw material sourcing
- Quality Management system and raw materials
- Cell culture media
- Viral safety of raw materials
- Single sourcing versus dual sourcing
- critical parameters from a manufacturers' perspective
15:10
Strategies for cultivating stem cells under physiological conditions
- Isolation of human mesenchymal stems cell from different sources
- Expansion / upscaling
- Differentiation towards different lineages
15:10
Advances in chromatographic stationary phases
- Novel chromatographic stationary phases
- Efficiency and selectivity trade off
- Impact on biomolecule downstream process
15:10
Formulation and analytical challenges in developing biosimilars
- Importance of orthogonal analytical methods
- Evaluation of different drug substance (DS) manufacturing methods
- Screening of drug product (DP) formulations identical or similar to originator
- Study and comparison of formulation ingredients
- Comparison of different batches of originator and biosimilar DP
- Studies of formulation interactions with human plasma and blood
15:30 Networking Break
Fill & Finish
16:30
Defining and documenting the Influence of Process Development on Product Quality
- Workflow for Stage I Process Validation key to understanding and success
- Defining strategies for risk assessments to better understand your processes for late stage process development.
- Understanding the influence of process on quality attributes of your produce and defining process limits.
- Strategies to improve success in process scale-up, transfer and validation
16:30
Scale-up Strategies for Cell Culture Processes and their Support by Computational Fluid Dynamics (CFD)
- Scale-up and down of cell culture processes
- Scale-up approaches at Boehringer Ingelheim
- How CFD can support Scale-up
16:30
Novel chromatographic processes for cell and gene therapy biopharmaceuticals
- Scaled down development processes allow higher productivity recoveries and titers of viruses for use in gene therapy; robust design is easy
- Continuous chromatographic steps can further improve gene therapy viral production stability
- New products and processes allow purification and concentration of cells for therapy biopharmaceuticals
16:30
Derisking approach for fill & finish process of biologics
- Overview of main risks associated to the fil &finish process from thawing to Filling
- What Studies should be performed
- Risk mitigation
Upstream - Quality control and analytics
16:50
Optimizing protein solubility and stability within Aqueous Two-Phase Extraction
- How system selection for ATPE can be simplified through hybrid-shortcut calculations
- Identification of appropriate displacement agents based on CG-MALS measurements
- Increasing protein solubility and stability through synergic combinations of excipients
16:50
Manufacturing, Formulation, and Product Delineation
- Are all stem cells the same?
- MSC manufacturing processes and product portfolio
- Formulation and MSC product attributes
16:50
Custom Affinity Chromatography – a Novel Platform for Rapid Development of Affinity Media Displaying DNA Aptamer Based Ligands
- High-throughput selection and characterization of affinity ligands
- Rapid prototype affinity column fabrication and validation
- Application to non-mAb product in phase III trials
16:50
Differentiated product concepts of biopharmaceuticals through innovative formulation approaches
- Product differentiation – essential to succeed in competitive markets
- Formulation and smart devices are key to differentiation
- Novel approaches in formulation can result in superior product characteristics
- Exploiting unique characteristics of excipients in formulation design
17:10
Real time access to volatile organic compounds in fermentation process head space gas via Proton transfer reaction mass spectrometry (PTRMS) - a doorway to process understanding and QbD implementation
- PTRMS a bioprocess PAT tool for qualitative and quantitative real time monitoring of volatile organic compounds
- Implementation of PTRMS as fermentation process monitoring tool
- VOC reference analysis based on solid phase microextraction (SPME) based sampling combined with GC-MS analysis
- Composition and time courses of VOC matrices in the off-gas streams of E. coli and CHO fedbatch processes.
- VOC and process understanding, advanced process control and implementation of QbD concepts
17:10
Bridge Building: How to Manage Complex Technology Transfers
- What are the considerations required to ensure a smooth transfer of operations from R&D to Manufacturing?
- Evaluation of critical aspects to ensure event-free manufacturing
- Discovering the importance of cross-functional communication and collaboration to promote successful routine biomanufacturing operations
17:10
Platform alternatives for scFv and mAb
- Aqueous Two Phase Extraction as capture step for scFv and mAb
- Precipitation of host cell proteins and/or IgG as one purification method
- new continuous chromatography, called integrated Counter Current Chromatography (iCCC) with superb purity/yield as purification and polishing step
17:10
Formulation of oral inhaled products and a multiparameter in vitro cell culture assay to assess formulation effects on macrophages
- Formulation strategies for oral inhaled products
- The impact of formulation on inhaled product safety testing, especially with regard to macrophage responses
- Development of a multiparameter in vitro assay to assess macrophage responses to inhaled medicines
17:40 Networking drinks reception
last published: 17/Feb/17 11:15 GMT
Organiser
