Downstream Processes

Area Coordinators: Nihau Tugcu, Venkatesh Natarajan, Raquel Aires-Barros

Downstream Processes:

Session: Advances in Chromatographic Separations I&II 

Session: Advances in Non-Chromatographic Separations

Session: Downstream Processing for Antibodies, Drug Conjugates and Novel Formats I&II

Session: Downstream Processing for Vaccines, Gene Therapy Vectors, Cell Therapy, Stem Cell and Non-Protein Biological Products I&II

Session: Technology Transfer, Scale-up and Scale-Down in Downstream Processing

Session: Automated Technologies and High Throughput Systems in Biologics Production: Downstream Processing

Session: Disruptive Bioprocessing and Process Integration: Downstream Processing 


Session: Advances in Chromatographic Separations I&II

Session chairs:

Name: David Roush

Affiliation: Merck

Email: david_roush@merck.com                      

 

Name: Jim Neville

Affiliation: EMD Millipore

Email: jim.neville@emdmillipore.com                         

 

Name: Aleš Podgornik 

Affiliation: University of Ljubljana, Slovenia

Email: ales.podgornik@cobik.si

 

Session description:

The session will examine both practical and theoretical aspects of current chromatographic applications ranging from high throughput screening (HTS) to scale-up and implementation in commercial manufacturing. Topics include the development of novel materials and formats, different processing strategies (e.g. continuous chromatography), examples utilizing process analytical technologies (PAT) to advance separation, advances in tools for high throughput process development (HTPD), process optimization and troubleshooting, advances in scale-up procedures and process scale implementation.  Research focusing on mechanistic modeling of chromatographic processing  and understanding of molecular-level interactions that govern protein or vaccine adsorption behavior on chromatography surfaces and that combine theory and practice in the above-mentioned topics are strongly encouraged.

 

 

Session: Advances in Non-Chromatographic Separations

Session chairs:

Name: Elaheh Benabaji

Affiliation: Amgen

Email: elahehb@amgen.com                          

 

Name: Ana Azevedo

Affiliation: Instituto Superior Técnico, Universidade de Lisboa, Portugal

Email: a.azevedo@ist.utl.pt

 

Session description:

From centrifugation, flocculation, and filtration-based methods for cell harvest/clarification to microfiltration for virus clearance to ultrafiltration for product concentration and final formulation, non-chromatographic bioseparation techniques are essential for manufacturing of all biological products providing many of the separations necessary for purification these biomolecules. Current challenges also include not only combining more than one unit operation into an integrated process but also integrating both upstream and downstream processes. This session seeks to report advances in the development, fundamental understanding, and industrial application of unit operations that employ non-chromatographic approaches to achieve a desired bioseparation, as well as cases demonstrating the advantages/disadvantages of the overall integrated process. Operations of interest may include all modes of centrifugation, filtration and membrane processes, aqueous multiphase partitioning, precipitation, crystallization and polymeraided flocculation as well as more exotic bioseparation technologies. Both experimental and modeling submissions are welcome, with priority given to those that provide insights and approaches of general utility, and for which experimental and/or manufacturing implementation is shown and compared with alternative approaches.

 

 

Session: Downstream Processing for Antibodies, Drug Conjugates and Novel Formats I&II

Session chairs:

Name: Asif Ladiwala

Affiliation: Genentech

Email: ladiwala.asif@gene.com

 

Name: Nooshafarin Sanaie

Affiliation: Gilead

Email: Nooshafarin.sanaei@gilead.com

 

Name: Marco Rito-Palomares

Affiliation: Centro de Biotecnologia-FEMSA, Tecnologico de Monterrey, Mexico

Email: mrito@itesm.mx

 

Session description:

Demand for bringing new and more potent therapeutics to the market has grown substantially in recent years.  Since many monoclonal antibodies are not sufficiently potent to be therapeutically active on their own, there have been continued efforts toward coupling proteins with other molecular entities to create more targeted and innovative therapies (i.e. antibody-drug conjugates). Development of other novel biomolecular entities such as Fc – fusion proteins, antibody fragments, bispecific antibodies is also rapidly growing.   Recent advances focused on generating these novel formats are constantly demanding more efficient downstream processes in order to handle high titers, highly concentrated process pools, and/or challenging process or product-related impurities.


This session calls for papers focused on new and enhanced downstream processing of antibodies and related molecules, including protein conjugates. 
Following topics are particularly encouraged:
(1) Optimization of conjugation chemistry/unit operations, especially to increase the yield of the desired conjugated product
(2)  Purification of the conjugation products, while addressing any challenges in removing undesired conjugation byproducts
(3) Creative approaches to handling unstable products or difficult-to-remove impurities
(4) Novel purification strategies for the recovery of modified molecules, especially PEGylated products

 

Session: Downstream Processing for Vaccines, Gene Therapy Vectors, Cell Therapy, Stem Cell and Non-Protein Biological Products I&II

Session chairs:

Name: Aaron Noyes

Affiliation: Pfizer

Email: Aaron.Noyes@pfizer.com             

Name: Meisam Bakhshayeshi

Affiliation: Biogen

Email: meisam.bakhshayeshirad@biogen.com                                

 Name: Alois Jungbauer

Affiliation: Department of Biotechnology, University of Natural Resources and Austrian Centre of Industrial Biotechnology, Vienna, Austria

Email: alois.jungbauer@boku.ac.at

 

Session description:

Beside proteins, viruses, virus like particles, exosomes, cells, synthetic RNA, plasmids, mini-chromosomes, and subcellular fractions are a potential class of very promising biopharmaceuticals; often also referred to as bionanoparticles. Downstream processing of these biopharmaceuticals is different from conventional protein drugs with unestablished regulatory framework. These new entities differ in size, size distribution and other biophysical properties related to separation. Frequently in-process control methods are not well established. In this session the strategies for purification of bionanoparticles will be covered. This includes the primary recovery from the culture broth, capture and further purification using chromatography media, membrane filtration, extraction technologies, differential centrifugation and affinity technologies. In-process control methods will be also discussed and strategies for fast analytics to circumvent time consuming bioassays and imaging methods. We encourage submitting papers on laboratory scale methods, scale up, in-process control and structural characterization to understand downstream processing of bionanoparticles.

 

Session: Technology Transfer, Scale-up and Scale-Down in Downstream Processing 

Session chairs:

Name: Scott Tobler

Affiliation: Merck

Email: scott_tobler@merck.com                          

 

Name: Ben Roman

Affiliation: EMD Millipore

Email: benjamin.roman@emdmillipore.com

 

Session description:

When transferring biotechnological processes to manufacturing facilities, the scale-up and scale-down of downstream unit operations is not always obvious and straightforward.  Assuring successful implementation in a facility can require new approaches to scaling and/or modeling to gain additional insight in comparison to traditional approaches.  These may include fundamental/engineering models used to anticipate large scale performance, as well as development of appropriate small-scale models used for process characterization and/or troubleshooting.  We seek abstracts covering these scale-up and scale-down topics, particularly for cases where challenges related to scaling and facility fit were observed and novel solutions were required to drive successful implementation.  Case studies covering adoption of new paradigms (including an increased reliance on disposable/flexible technologies) with a focus on increased commercial robustness and/or design space, as well as productivity increases and/or cost reduction through innovation are encouraged.  Abstracts that highlight recent trends and areas of key focus during health authority review are relevant, including abstracts that cover technology transfer and product comparability challenges and how they were addressed.

 

 

Session: Automated Technologies and High Throughput Systems in Biologics Production: Downstream Processing 

Session chairs:

Name: Jennifer Pollard

Affiliation: Merck

Email: jennifer_pollard@merck.com                     

 

Name: Marcel Ottens

Affiliation: Delft University of Technology, The Netherlands

Email: M.Ottens@tudelft.nl

 

Session description:

High-throughput process development (HTPD) has become a more accepted experimental approach in industry, being applied to process optimization through Design of Experiments as well as a more fundamental approach using mechanistic models. This session will continue to explore these applications and focus on new methods of utilizing high throughput techniques for chromatography and other unit operations. Topics included are examples where HTPD workflows have replaced traditional process development, case studies showing the translation and scale-up of HTPD data, advances in tools and evaluation of new technology for HTPD, and application of high throughput data for process understanding via the use of modeling. Submissions that expand the use of HTPD beyond chromatography are particularly sought. 

 

 

Session: Disruptive Bioprocessing and Process Integration: Downstream Processing 

 

Session chairs:

Name: Mark Brower

Affiliation: Merck

Email: mark_brower@merck.com                                     

 

Name: Steve Cramer

Affiliation: Rensselaer Polytechnic Institute

Email: crames@rpi.edu

 

Session description:

In the ever-increasing drive to reduce speed to clinic and speed to market the bioprocess industry tends to rely on familiar, aging techniques which have been proven on numerous molecules rather than perusing more modern alternatives which may offer benefits in terms of productivity and cost-of-goods.  Biopharmaceutical companies often choose to defer to the ‘known’ rather than risk upset in the regulatory approval process or organizational changes to existing development workflows optimized towards a platformed manufacturing infrastructure.  Can the industry maintain this strategy or will it be forced to adapt to the emerging global demand for their products at significantly reduced cost by embracing disruptive technologies?  In this session, we solicit abstracts that cover the development, scale-up, and successful implementation of disruptive technologies in downstream processes for either mAb or non-mAb molecules.  The development of continuous processes or connected downstream steps that enable straight-through processing are relevant. Non-traditional processes that utilize innovative technologies, such as crystallization, precipitation, extraction, selective affinity tags and state-of-the-art purification or process analytical technologies are welcome.  Papers that demonstrate the holistic impact to the downstream process by incorporating one of these steps is of particular interest.  Papers that challenge the need for disruptive change to established downstream processes are also encouraged.