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Making Downstream Processing Continuous and Robust a Virtual Roundtable S BIOPROCESS TECHNICAL Making Downstream Processing Continuous and Robust A Virtual Roundtable S. Anne Montgomery, Cheryl Scott, and Peter Satzer, with Margit Holzer, Miriam Monge, Ralph Daumke, and Alexander Faude urrent biomanufacturing is driven to pursue continuous processing for cost reduction and increased productivity, Cespecially for monoclonal antibody (MAb) production and manufacturing. Although many technologies are now available and have been implemented in biodevelopment, implementation for large-scale production is still in its infancy. In a lively roundtable discussion at the BPI West conference in Santa Clara, CA (11 March 2019), participants touched on a number of important issues still to be resolved and technologies that are still in need of implementation at large scale. Below, moderator Peter Satzer (senior scientist RENTSCHLER BIOPHARMA (WWW.RENTSCHLER-BIOPHARMA.COM) with the Austrian Center of Industrial Biotechnology, Vienna) summarizes key points raised in that session. Based on Requirements for integration without the need for hold his highlights, BPI asked a number of Continuous Downstream tanks between unit operations requires industry representatives to comment on further exploration. those points further, and their Applications Chromatography Operations: Some responses follow. by Peter Satzer unit operations such as flow-through chromatography and single-pass, Minimizing Buffer and Hold Tanks: One tangential-flow filtration (SPTFF) can be critical parameter is integration of unit integrated easily into a continuous Product Focus: Biologics operations on manufacturing shop downstream process scheme at any floors using minimum numbers of point because they offer constant inflow Process Focus: Downstream buffer tanks and hold tanks. The benefit and outflow of material. Such operations processing of continuous manufacturing can be can be called truly or fully continuous. realized fully only if auxiliary Other unit operations — especially Audience: Process developers, equipment for buffer preparation and bind–elute chromatography — are much manufacturing, operations hold tanks are minimized between harder to implement because they don’t Keywords: Filtration, Buffer downstream operations. Although provide truly continuous operation, but preparation, chromatography, continuous buffer preparation and rather produce individual elution peaks virus safety reduction of buffer hold tanks are being with fluctuating product and impurity investigated (and also were the subjects concentrations. Usually the unit Level: Intermediate of BPI West presentations), direct operation following such a step cannot 38 BioProcess International 17(6) June 2019 17-6-Satzer-RT.indd 38 8/28/2019 10:29:21 AM Roundtable Participants for batch definition and to minimize drug-substance manufacturing. A couple Peter Satzer (senior scientist with the product loss in case of contamination, a decades of production improvements have Austrian Center of Industrial Biotechnology, broad residence-time distribution created challenging process streams for Vienna) smooths process irregularities and leads separation and purification. Can continuous Margit Holzer principal at Ulysse Consult to a more robust process. The trade-off downstream processes offer a partial between those two approaches will need solution to this problem? BPI editorial advisor and Miriam Monge to be discussed in the future. Satzer: Continuous downstream head of the MAb and intensified PCC Chromatography: PCC can be processes can offer solutions in two bioprocessing market segment at Sartorius detrimental to our understanding of separate ways. The first way is to Stedim Biotech SA (whose comments residence-time distribution because it increase downstream equipment use by include insights from colleagues Ganesh Kumar, Tom Erdenberger, and Hemanth can split it during an operation. A PCC using equipment 24–7 and therefore Kaligotla, members of the Sartorius MAb operation will produce one or two increasing downstream productivity. and intensified market segment team) residence-time distribution peaks The second way is through a change in depending on the state of the operation, mindset, in which up- and downstream Ralph Daumke biotechnology market and no easy model can be applied. If operations are integrated directly rather manager life science, FILTROX Group bind–elute polishing also is than remaining distinct and separate — Alexander Faude, PhD, director DSP implemented using PCC, the resulting which forces them into direct development at Rentschler Biopharma residence-time distribution can be split communication. That opens the (whose comments include those of into up to four individual distributions possibility of solving problems earlier colleagues director DSP process Thilo Grob traveling through the system, which (upstream), where solutions might be design/validation and Anja Trapp senior complicates decisions about when to easier to achieve. scientist) discard material. Currently, this issue is Holzer: Great improvements have too poorly understood and modeled. It been made in cell-specific productivity, handle such changes in flow and either is not addressed, is addressed media development, and process design concentration directly, requiring with wide safety margins for discarding during recent decades, resulting in some inclusion of surge vessels and hold material, or is addressed by cases up to 100× increased product tanks that interrupt the process. This implementing a hybrid process that uses concentration in fermentation broth. makes continuous periodic batch manufacturing after a PCC unit The product output of the same countercurrent chromatography (PCC) a operation. upstream installation could be unit operation that is harder to Alternative technologies to bind– increased proportionally. implement than other operations such elute chromatography such as flow- However, improvements in as flow-through chromatography and through chromatography, precipitation, chromatography media capacity and new, alternative purification methods, crystallization, and flocculation can membrane performance have not given including continuous precipitation. offer solutions to those issues in the the same range of productivity increase, Viral Inactivation: Current future to preventing integration instead doubling or tripling it. implementation of continuous problems. Developers of future Therefore, work is needed on process processing in the MAb world could make technologies should aim for a constant design to overcome the downstream use of viral inactivation steps as surge mass flow through all unit operations, bottleneck. Related design studies easily vessels. Biomanufacturers could fill enabling integration and a seamless show the great potential of continuous parallel vessels periodically and empty downstream process train. processing. them to provide constant flow and Monge: Recent advances in product concentration for subsequent upstream processing have led to unit operations. This might not be The Roundtable Discussion processes in which expression titers possible for all antibody and Based on the discussion highlights have increased beyond 10 g/L or even nonantibody products, however. above, BPI invited further insights from 20 g/L. Availability of concentrated fed- Alternative purification techniques such several advisors, end users, and batch options on a pilot and as continuous precipitation offer a supplier companies. Included below are commercial scale has resulted in DSP constant inflow and outflow of material additional comments from Satzer along handling product amounts ranging and prevent integration issues. with responses from participants listed from 5 kg to 40 kg per batch. On one Residence-Time: Another important in the box at the left. BPI invites further hand, process intensification efforts point to consider when thinking about comments and welcomes submitted have reduced overall footprint and time continuous integrated unit operations is manuscripts detailing how your in the upstream train by eliminating the residence-time distribution through organization approaches these issues. intermediary seeding steps. But this all unit operations. Understanding of has led to an increased footprint in this concept is limited, but it is critical Capacity Mismatch downstream processing (DSP) that has to ensure batch definition and ensuring We’ve heard recent discussion about a required some biopharmaceutical process robustness. Although a narrow “capacity mismatch” between upstream and companies to switch from single-use to residence-time distribution is preferred downstream aspects of biopharmaceutical hybrid/stainless steel technologies. 40 BioProcess International 17(6) June 2019 17-6-Satzer-RT.indd 40 8/28/2019 10:29:21 AM One way to address the challenge is Satzer: The final goal has to be considerable decrease in downstream to implement multicolumn preparation of buffers and media based buffer demand. Choosing the right chromatography at the capture step to on powders or concentrates. For buffer-management strategy would ease the burden or to have continuous concentrated buffers (and reduction of require a company not only to evaluate DSP with perfusion-based upstream different buffers used in the complete the buffer demand on a unit operation processing (USP) — enabling downstream stream), efforts have been and process level, but also to evaluate biopharmaceutical companies to made already and the first prototypes the impact of each proposed preparation debottleneck
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