CCDWC 2017 Day 1

08:00 Registration Opens


Conference doors open


Opening and Welcome from Terrapinn

Opening Plenary Sessions: New developments for Cell Culture and Downstream Processing in 2017

Dr Hitto Kaufmann

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
Professor Klaus Cichutek

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
Professor Massimo Morbidelli

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

Keynote Q&A session

10:45 Networking Break

round tables

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

    Dr Manfred Papaspyrou, Head Marketing & Sales, Glycotope Biotechnology GmbH

  • TABLE 3: Drug products - formulation, fill and finish
  • Prof. Tudor Arvinte

    Prof. Tudor Arvinte, President and Chief Executive Officer, Therapeomic Inc


    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



    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

    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

    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

    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.

    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

    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

    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


    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

    Advances in chromatographic stationary phases

    • Novel chromatographic stationary phases
    • Efficiency and selectivity trade off
    • Impact on biomolecule downstream process

    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


    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

    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

    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


    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

    Manufacturing, Formulation, and Product Delineation

    • Are all stem cells the same?
    • MSC manufacturing processes and product portfolio
    • Formulation and MSC product attributes

    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

    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

    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

    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

    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

    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