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Full-Text Articles in Biomedical Engineering and Bioengineering

Monitoring And Control Of Reproducibility In Quasi-Continuous Integrated Production Processes Of Active Pharmaceutical Ingredients, Reiner Luttman, Sven Oliver Borchert, Jan Patrick Voss, Gesine Cornelissen Nov 2015

Monitoring And Control Of Reproducibility In Quasi-Continuous Integrated Production Processes Of Active Pharmaceutical Ingredients, Reiner Luttman, Sven Oliver Borchert, Jan Patrick Voss, Gesine Cornelissen

Integrated Continuous Biomanufacturing II

The development of integrated production processes include the combination and transformation of current batch oriented unit operations into linked sequential/parallel production strategies.

The presented process starts with a two-stage upstream consisting of cell cultivation and subsequent protein production, which in turn results in a five step downstream process, consisting of cell clarification via a separator, retention of cellular debris using microfiltration, concentration of the secreted product by ultrafiltration with subsequent buffer exchange through diafiltration, followed by a final purification using column chromatography.

The three main operations cell breeding, protein production and the complete downstream line are running in series ...


Protein Refinery Operations Lab (Pro Lab): A Sandbox For Continuous Protein Production & Advanced Process Control, Mark Brower, David Pollard, Finn Hung Nov 2015

Protein Refinery Operations Lab (Pro Lab): A Sandbox For Continuous Protein Production & Advanced Process Control, Mark Brower, David Pollard, Finn Hung

Integrated Continuous Biomanufacturing II

Significant strides towards implementation of continuous bioprocessing are being made at an ever increasing rate. Advances in technology for traditional unit operations such as cell-retention devices in perfusion cell culture, continuous multi-column chromatography (CMCC) and single-pass tangential flow filtration have led to demonstrations of both semi-continuous and fully-continuous protein production processes operating at periodic steady states at the pilot-scale. Previous proof of concept work at Merck & Co., Inc. has shown an automated (DeltaV) and single-use monoclonal antibody (mAb) purification scheme through Protein A CMCC and pH viral inactivation with minimal human interaction for 30 days fed from a perfusion bioreactor ...


Leveraging Large Data Sets In Continuous Chromatography Applications: Monitoring Critical Process Parameters Using Mvda, Engin Ayturk Nov 2015

Leveraging Large Data Sets In Continuous Chromatography Applications: Monitoring Critical Process Parameters Using Mvda, Engin Ayturk

Integrated Continuous Biomanufacturing II

Continuous multicolumn chromatography is gaining momentum in the industry as an enabling technology to establish continuous biomanufacturing platforms for monoclonal antibodies and recombinant proteins. Some companies are exploring continuous multicolumn chromatography processes as a stand-alone unit operation to improve specific productivity and/or reduce buffer consumption, while other companies are considering an integrated continuous downstream process based on continuous multicolumn chromatography.

One of the key features of continuous multicolumn chromatography is the amount of data generated during a single manufacturing batch or campaign. Traditional chromatography processes typically yield one (or a few) elution peaks per batch. Continuous chromatography processes, on ...


Pat Concepts For Chromatography: Real-Time Monitoring, Real-Time Control, And Cause Of Error Diagnostics, Nina Brestrich, Tobias Hahn, Adrian Sanden, Till Briskot, Jurgen Hubbuch Nov 2015

Pat Concepts For Chromatography: Real-Time Monitoring, Real-Time Control, And Cause Of Error Diagnostics, Nina Brestrich, Tobias Hahn, Adrian Sanden, Till Briskot, Jurgen Hubbuch

Integrated Continuous Biomanufacturing II

In the recent years, the growing competition in the biopharmaceutical industry due to biosimilars combined with market fluctuations and increasing product pipelines have given rise to the evaluation of continuous processing. Advantages include smaller equipment that may be disposable, an overall process intensification as well as steady-state operation. As variability should be managed by the continuous process itself to insure a consistent product quality, the development of advanced Process Analytical Technology (PAT) concepts is one crucial aspect for the implementation of continuous processing.

In chromatographic protein purification, process variability can lead to variations in retention volumes or peak shapes of ...


Dynamic Oncolytic Measles Virus Production, Tanja Grein, Denise Salzig, Michael Muehlebach, Peter Czermak Nov 2015

Dynamic Oncolytic Measles Virus Production, Tanja Grein, Denise Salzig, Michael Muehlebach, Peter Czermak

Integrated Continuous Biomanufacturing II

Oncolytic viruses can be effective weapons against cancer with few treatment options. For example the tissue culture–adapted Edmonston strains of measles virus (MV) have altered its receptor specificity and became selectively oncolytic with attenuated pathogenicity. Russel et al. showed in 2014 full remission in an advanced stage multiple myeloma patient after systemic application of genetically modified MV. In this clinical trial, the patient was treated by intravenous infusion of 1011 TCID50 (50% tissue culture infectious dose) - of an engineered MV encoding human sodium iodide symporter. Appropriate medical treatment with oncolytic viruses calls for high concentrations and absolute ...


How Continuous-Like Processes Improve Affordability For Viral Vaccines - Example Of Laiv, Jose Castillo Nov 2015

How Continuous-Like Processes Improve Affordability For Viral Vaccines - Example Of Laiv, Jose Castillo

Integrated Continuous Biomanufacturing II

Designing a continuous process for a life viral vaccine could be seen useless, and challenging, as the virus infection will kill the cell substrate after 2-5 days of infection.

From the technical perspective, chaining the operations of cell culture under perfusion and viral production, clarification and capture / concentration is an efficient option to setup a small scale continuous automated process to manufacture massive amounts of viral vaccines.

We will show how beneficial it can be in terms of process development, manufacturing simplicity, capital expenditure and cost of production. Also, we will show how this approach can help producers of viral ...


Small-Scale Platform For Rapid On-Demand Manufacturing Of Recombinant Proteins, J. Christopher Love Nov 2015

Small-Scale Platform For Rapid On-Demand Manufacturing Of Recombinant Proteins, J. Christopher Love

Integrated Continuous Biomanufacturing II

The current timeline for manufacturing high-quality recombinant proteins used for therapeutics and vaccines, and delivering them to patients, typically requires many months. There are many circumstances, however, where the rapid production, release, and delivery of these biologics could address unmet medical needs, including shortages, emergency situations, and pandemics. This talk will present a new platform developed to produce biologic medicines on demand called Integrated and Scalable Cyto-Technology (InSCyT). This platform comprises an integrated, subliter-scale portable system for the (semi)continuous operation of fermentation, filtration of cell debris from secreted product, innovative affinity-based purification, polishing, and finishing. This program also emphasizes ...


Cder's Emerging Technology Team, Kurt Brorson, Sau Lee Nov 2015

Cder's Emerging Technology Team, Kurt Brorson, Sau Lee

Integrated Continuous Biomanufacturing II

The newly formed Emerging Technology Team (ETT) draws membership from all CDER quality review, research and inspection functions, including Office of Biotechnology Products. The goal of the ETT is provide a primary point of contact for external inquiries regarding emerging technology in pharmaceutical and biotechnology manufacturing and quality control. The ETT will partner with review offices in a cross-functional manner and identify regulatory strategy and resolve roadblocks to new technologies relating to existing guidance, policy or practices related to review or inspection. The ETT’s initial focus will be innovation on novel products, manufacturing processes, or testing technologies or processes ...


Exploring Continuous And Integrated Strategies For The Up- And Downstream Processing Of Human Mesenchymal Stem Cells, Barbara Cunha, Tiago Aguiar, Ricardo Silva, Cristina Peixoto, Manuel Carrondo, Margarida Serra, Paula Alves Nov 2015

Exploring Continuous And Integrated Strategies For The Up- And Downstream Processing Of Human Mesenchymal Stem Cells, Barbara Cunha, Tiago Aguiar, Ricardo Silva, Cristina Peixoto, Manuel Carrondo, Margarida Serra, Paula Alves

Integrated Continuous Biomanufacturing II

The integration of up- and downstream unit operations can result in the elimination of hold steps, thus decreasing the footprint, and ultimately can create robust closed system operations. This type of design is desirable for the bioprocess of human mesenchymal stem cells (hMSC), where high numbers of pure cells, at low volumes, need to be delivered for therapy applications. The aim of this work is to perform a proof of concept of the integration of a continuous perfusion culture in bioreactors with a tangential flow filtration (TFF) system for the concentration and washing of hMSC. In particular, we have evaluated ...


Regulatory Challenges Of Continuous Biomanufacturing, Andy Papas Nov 2015

Regulatory Challenges Of Continuous Biomanufacturing, Andy Papas

Integrated Continuous Biomanufacturing II

The interaction with regulatory agencies on the biomanufacturing of therapeutic proteins, mAbs, or other large molecules occurs throughout the drug development of the biologic; it begins with the original IND, accelerates at the licensing phase and continues throughout the product’s life cycle. There are many regulatory challenges along this journey.

Because of uniqueness of continuous biomanufacturing, one challenge that occurs throughout the product’s lifecycle is the inevitable change in Agency product reviewers who many times need to be educated on the nuances of your process or have a different opinion or expectation on how things should be done ...


A Regulatory Perspective On Continuous Perfusion Production Of Rfviii, Robert Kozak Nov 2015

A Regulatory Perspective On Continuous Perfusion Production Of Rfviii, Robert Kozak

Integrated Continuous Biomanufacturing II

Continuous perfusion production has enabled flexible manufacturing of rFVIII, a large complex Biotech Product, for over two decades. Continuous improvement has driven frequent process, equipment and facility changes successfully performed utilizing comparability exercises.

Challenges in evaluating changes made to a continuous perfusion process includes assessment of impact to quality product attributes throughout the entire fermentation campaign which can be months in duration. Examples of process changes requiring more studies, those successfully supported by small scale development runs and API commercial characterization and an example resulting in non-implementation will be reviewed. Impact of changing Regulatory Environment on submission package requests will ...


Quality Systems For Continuous Manufacturing, Ron Branning Nov 2015

Quality Systems For Continuous Manufacturing, Ron Branning

Integrated Continuous Biomanufacturing II

Continuous manufacturing is a familiar concept in large volume commercial commodity operations such as glass and plastic production. In the wake of the Tylenol cyanide poison scare in the 1970’s, pharmaceutical production at the J&J subsidiary McNeil converted to virtually closed, continuous manufacturing. Several Biotech firms tried to develop fermentation unit operations in the 1990’s that were based on the continuous manufacturing concept. Today there are a number of initiatives to update and realize the concept from bench top, such as MIT and Novartis’ sponsorship of start up firm Continuus’ production of solid dosage forms in Boston ...


Transforming The Present Into The Future With Uncertainty And Imprecision, Chales Cooney Nov 2015

Transforming The Present Into The Future With Uncertainty And Imprecision, Chales Cooney

Integrated Continuous Biomanufacturing II

No abstract provided.


Advanced Computational Tools To Enhance Continuous Monoclonal Antibody Production, Maria M. Papathanasiou, Ana Quiroga, Athanasios Mantalaris, Efstratios Pistikopoulos Nov 2015

Advanced Computational Tools To Enhance Continuous Monoclonal Antibody Production, Maria M. Papathanasiou, Ana Quiroga, Athanasios Mantalaris, Efstratios Pistikopoulos

Integrated Continuous Biomanufacturing II

Leading pharmaceutical companies invest high percentage of their revenue in the improvement of existing technologies used for the production of monoclonal antibodies (mAbs). Recently, there has been a paradigm shift towards the development of continuous/quasi-continuous purification operations, aiming to reduce capital and operational costs [1]. At the moment, however, there are no standardized methods and/or tools that can be used for global control and monitoring of integrated processes.

Mathematical models and advanced computational tools can be the key for the development of robust, integrated processes, as they can provide valuable insight in the process dynamics and ensure optimal ...


Integrated Continuous Bioprocessing – Opportunities And Challenges, Mats Akesson, Martin Heitmann, Ditte Skipstrup, Peter Tiainen Nov 2015

Integrated Continuous Bioprocessing – Opportunities And Challenges, Mats Akesson, Martin Heitmann, Ditte Skipstrup, Peter Tiainen

Integrated Continuous Biomanufacturing II

We have developed an integrated continuous processing framework for end-to-end production of complex fragile proteins based on perfusion cultivation and automated multi-step purification [1,2,3]. Upstream, the integrated system consists of a stirred tank bioreactor with an ATF cell retention system. The clarified harvest directly enters an off-the-shelf ÄKTA chromatography system converted into a continuous purification unit. Two alternating capture columns precede an automated multi-step purification train with full flexibility and control of individual columns.

The integrated set-up enables compact automated bench-top factories converting cell culture media to purified protein in an efficient manner without intermediate storage. It provides ...


Design And Control Of Chromatography Step In An Integrated Column Sequence, Bernt Nilsson, Niklas Andersson, Anders Holmqvist, Anton Sellberg, Peter Tiainen, Arne Staby Nov 2015

Design And Control Of Chromatography Step In An Integrated Column Sequence, Bernt Nilsson, Niklas Andersson, Anders Holmqvist, Anton Sellberg, Peter Tiainen, Arne Staby

Integrated Continuous Biomanufacturing II

Integration of the purification steps in downstream processing is one way to minimize the number of storage tanks and reduce hold-up time. The result is an integrated column sequence that performs straight through processing of the target protein, with minimal time from expression to formulation. This paper discusses the overall integration design and its expected performance, together with a more detailed analysis of the step behavior based on column simulations. The optimal design of the individual steps in the sequence is presented, both with robustness margins and local control system, as well as with and without local recycle.

An optimization ...


Integrated Continuous Processing For The Manufacture Of Monoclonal Antibodies, Daniel Karst, Fabian Steinenbach, Massimo Morbidelli Nov 2015

Integrated Continuous Processing For The Manufacture Of Monoclonal Antibodies, Daniel Karst, Fabian Steinenbach, Massimo Morbidelli

Integrated Continuous Biomanufacturing II

Continuous manufacturing is currently being considered by the Biopharmaceutical Industry not only for the classical reasons which make continuous operation preferred over the batch one, but also for recent initiatives of the regulatory agencies. We discuss here a series of experiments where a perfusion reactor with CHO cells for the production of a monoclonal antibody has been operated in the continuous mode and connected to a two column continuous protein A chromatographic unit for product capture. A few steady states are examined and the use of simulation models for process design and control is illustrated.


Continuous Culture And Downstream Processing Of Algae With Recycle: An Integrated Large-Scale Approach For Production Of Renewable Crude Oil, Matt Croughan Nov 2015

Continuous Culture And Downstream Processing Of Algae With Recycle: An Integrated Large-Scale Approach For Production Of Renewable Crude Oil, Matt Croughan

Integrated Continuous Biomanufacturing II

In order to have a significant impact on energy security and reduction of greenhouse gasses, the production of advanced biofuels must be increased to billions of gallons per year. Scale up of phototrophic algae bioprocessing for renewable oil production has been attempted for decades and has recently reached new levels of performance and scale. For over three years, Sapphire has successfully operated the world’s largest algae farm, consisting of 100 acres of ponds in New Mexico, used to feed an integrated conversion and extraction unit based on high temperature liquefaction technology. All aspects of the process are run on ...


Continuous Beer Production Methods: A Review Of Chances And Risks, Konrad Müller-Auffermann Nov 2015

Continuous Beer Production Methods: A Review Of Chances And Risks, Konrad Müller-Auffermann

Integrated Continuous Biomanufacturing II

Beer brewing is one of the oldest biotechnological processes applied by humans. The production methods are comparatively complex and time consuming, which is the reason why inventors and scientists have steadily attempted to improve its manufacturing.

During the industrial revolution more and more processes where done continuously in order to increase production efficiency. Breweries where trying to modify the classical batch modes into a continuous production process but were unsuccessful. Nearly all approaches failed due to changes of the beer quality.

The presentation shall give a brief overview of different continuous production concepts tested in the past 150 years. Furthermore ...


Delivering Steady-State Product Quality With An Intensified And Integrated Perfusion Cell Culture Process, Jason Walther, Neha Shah, Myles Hollenbach, Jonathan Wang, Marcela Yu, Jiuyi Lu, Konstantin Konstantinoc, Chris Hwang Nov 2015

Delivering Steady-State Product Quality With An Intensified And Integrated Perfusion Cell Culture Process, Jason Walther, Neha Shah, Myles Hollenbach, Jonathan Wang, Marcela Yu, Jiuyi Lu, Konstantin Konstantinoc, Chris Hwang

Integrated Continuous Biomanufacturing II

Continuous biomanufacturing provides many important strategic advantages for the production of protein therapeutics through process integration, simplification and intensification. To achieve upstream process intensification, Sanofi is currently developing robust cell culture processes that can achieve ultra-high cell densities and productivities (“push to high”) while minimizing cell-specific perfusion rates (“push to low”). We have applied ATF perfusion technology and improved the cell culture environment to achieve high cell densities and volumetric productivities with minimal ATF filter fouling. Meanwhile, we have employed high-throughput screening strategies to increase medium depth and reduce medium requirements. We will describe results as well as ongoing efforts ...


Exometabolome Characterization Of High Cell Density Culture Perfusion And Optimization Of The Cell Specific Perfusion Rate, Veronique Chotteau, Leila Zamani, Ye Zhang, Magnus Aberg, Anna Lindahl, Axel Mie Nov 2015

Exometabolome Characterization Of High Cell Density Culture Perfusion And Optimization Of The Cell Specific Perfusion Rate, Veronique Chotteau, Leila Zamani, Ye Zhang, Magnus Aberg, Anna Lindahl, Axel Mie

Integrated Continuous Biomanufacturing II

High cell density perfusion has the potential to generate intensified processes. A target for such perfusion process can be to maintain a steady state culture around 100 x 106 cells/mL. A challenge for the development of these processes is to minimize the medium consumption, to reduce the costs associated with this raw material and with the harvest processing. This is particularly true for processes at densities such as 100 x 106 cells/mL for which several reactor volumes per day are typically necessary.

We have shown that cell specific perfusion rate (CSPR) is an approach, which has ...


Development Of A First Generation Perfusion Process And Medium For Continuous Processing Based On Existing Fed-Batch Platform Media, Henry Lin, Samantha Wang, Robert Leighty, Scott Godfrey, Samet Yildirim, Adam Osborne, Flaka Radonigi, Jens Vogel, Jon Coffman Nov 2015

Development Of A First Generation Perfusion Process And Medium For Continuous Processing Based On Existing Fed-Batch Platform Media, Henry Lin, Samantha Wang, Robert Leighty, Scott Godfrey, Samet Yildirim, Adam Osborne, Flaka Radonigi, Jens Vogel, Jon Coffman

Integrated Continuous Biomanufacturing II

Process intensification leveraging perfusion offers tremendous potential for yield improvement over fed-batch processes for the production of monoclonal antibodies. In the context of continuous processing, the goal is to achieve highly intensified perfusion processes that allow substantial footprint reduction and enable flexible adaptation in new facilities. However developing a perfusion process and medium without prior technology requires leveraging the existing fed-batch platform knowledge. Evolving a medium for perfusion relies on designing suitable mixtures of basal and feed media that serve as adequate starting points for development. Focus on optimization of the medium to decrease byproduct waste, reduce unnecessary cell growth ...


Medium Optimization Case Study For Continuous Upstream Process, Rashmi Kshirsagar, Alan Gilbert Nov 2015

Medium Optimization Case Study For Continuous Upstream Process, Rashmi Kshirsagar, Alan Gilbert

Integrated Continuous Biomanufacturing II

Based on other mature industries, continuous upstream process is a logical replacement for current fed batch operations. However most industrial medium development has focused on the biological requirements for fed batch and therefore focused on the needs of stationary phase production. There is not an a priori expectation that growth and stationary phase requirements are identical. Yet an ideal continuous upstream process requires some combination of both. An optimal continuous upstream process requires a high cell density similar to fed batch operations. There is also some minimum growth rate required in order to match the combined death and cell removal ...


Upstream Perfusion Process: Back To The Future, Jean-Marc Bielser, Henri Kornmann, Herve Broly Nov 2015

Upstream Perfusion Process: Back To The Future, Jean-Marc Bielser, Henri Kornmann, Herve Broly

Integrated Continuous Biomanufacturing II

At an early stage of bioprocess science, continuous operations were the workhorse in the industry. Therefore, EMD-Serono has legacy with continuous upstream processes as many of its molecules such as Rebif are being produced in perfusion mode. These processes from the 90’s consume large volumes of commercial media and demonstrate low productivities. Cells are mainly attached because no performant cell retention device existed for cells in suspension at that time.

Around 10-15 years ago, the industry decided to move on fed-batch operations. EMD-Serono also re-oriented towards fed-batch operations. Molecules such as Erbitux are now being produced in 15,000 ...


Integration Of Continuous Ethanol Precipitation And Flocculation Into Manufacturing Of Antibodies, Alois Jungbauer, Nikolaus Hammerschimidt, Peter Satzer Nov 2015

Integration Of Continuous Ethanol Precipitation And Flocculation Into Manufacturing Of Antibodies, Alois Jungbauer, Nikolaus Hammerschimidt, Peter Satzer

Integrated Continuous Biomanufacturing II

Precipitation and flocculation are optimal unit operations for continuous capture of proteins from culture supernatant. Precipitation and flocculation can be operated in a real continuous manner. The methods can be combined and after this capture step the precipitate can be stored as a concentrated solution or even as a precipitate. We have developed several precipitation/ flocculation protocols for capture of antibodies from culture supernatant. These include the combinations of CaCl2 flocculation with either cold ethanol precipitation or PEG precipitation and octanoic acid precipitation with PEG precipitation. The precipitation conditions have been screened in microtiter plates or in case of ...


Considerations For An Incubation Chamber For Continuous Viral Inactivation, Raquel Orozco, Nancy Guillen, Loleta Chung, Scott Godfrey, Jon Coffman Nov 2015

Considerations For An Incubation Chamber For Continuous Viral Inactivation, Raquel Orozco, Nancy Guillen, Loleta Chung, Scott Godfrey, Jon Coffman

Integrated Continuous Biomanufacturing II

Continuous bioprocessing offers numerous benefits that have been highlighted recently in the literature. While substantial research efforts have allowed for relevant developments in continuous cell culture processes, downstream challenges, such as continuous viral inactivation, have not been addressed. The purpose of this work is to design a chamber that incubates a continuous product stream for a desired incubation time, typically for 1 hour. Since plug-flow cannot be achieved at typical incubation times and flow rates, one of the biggest challenges is to address dispersion of the product stream. Since several logs of viral clearance should be achieved during a virus ...


Robust Design And Operation Of Quasi-Continuous Adenovirus Purification By Two-Column, Simulated Moving-Bed, Size-Exclusion Chromatography, Jose Mota, Ricardo Silva, Piergiuseppe Nestolla, Cristina Peixoto, Manuel Carrondo Nov 2015

Robust Design And Operation Of Quasi-Continuous Adenovirus Purification By Two-Column, Simulated Moving-Bed, Size-Exclusion Chromatography, Jose Mota, Ricardo Silva, Piergiuseppe Nestolla, Cristina Peixoto, Manuel Carrondo

Integrated Continuous Biomanufacturing II

Adenoviruses (Ads) are considered one of the most suitable platforms for production of viral vaccines and gene therapy vectors. Their broad tissue tropism and large transgene packing capacity make them attractive candidates for innovative virotherapies. Ads can be produced in a complementary cell line in both adherent and suspension culture systems, such as HEK-293 or PER-C6 cells, or A549 for oncolytic therapies.

Liquid chromatography is currently the core technique for vector purification, and its use is often integrated vertically within the downstream processing (DSP) strategy, as it easily fits into the early capture stage as well as into the final ...


Continuous Downstream Process Or Connected Batch Process: Which One Makes Most Sense For Biogen?, John Pieracci, Sanchayita Ghose, Venkatesh Natarajan Nov 2015

Continuous Downstream Process Or Connected Batch Process: Which One Makes Most Sense For Biogen?, John Pieracci, Sanchayita Ghose, Venkatesh Natarajan

Integrated Continuous Biomanufacturing II

As biologics-based products move into therapeutic areas with large patient populations and high doses, batch processing may not be able to keep pace with product demands. At Biogen, we have been exploring a number of options that can enable higher productivity of our downstream processes. In addition to a fully “end to end” continuous process, a batch process comprised of several steps connected in series has been evaluated. In this presentation, technologies Biogen has evaluated to enable either continuous or connected processing will be shown. Multi-Column-Chromatography (MCC) for the Protein A capture chromatography step was evaluated in order to maximize ...


What Is Holding The Industry Back From Implementing Cbp (Continuous Bioprocessing) More Broadly?, Morten Munk Nov 2015

What Is Holding The Industry Back From Implementing Cbp (Continuous Bioprocessing) More Broadly?, Morten Munk

Integrated Continuous Biomanufacturing II

Introduction: Advances in pharmaceutical manufacturing technology in the last decade provide new opportunities to reinvigorate and improve the quality of pharmaceutical manufacturing. One of those technologies is Continuous Processing, which offers a wide range of advantages. Traditionally, most focus has centred on the cost advantages while the industry has held back on more broadly implementing Continuous Process. One reason for this reluctance concerns the viewpoint on the technology from the authorities, particularly FDA and EMA.

This presentation will discuss the results from a survey of industry peers performed by BioPlan Associates for NNE Pharmaplan. The focus of the survey is ...


Evaluating Facility Design And Capacity Planning Decisions For Clinical And Commercial Supply With Hybrid Continuous Processes, Suzanne Farid Nov 2015

Evaluating Facility Design And Capacity Planning Decisions For Clinical And Commercial Supply With Hybrid Continuous Processes, Suzanne Farid

Integrated Continuous Biomanufacturing II

Assessing the value potential of alternative process and facility design strategies will be critical to the successful management of continuous processes. UCL’s Decisional Tools team have developed advanced decision-support tools that effectively integrate concepts from bioprocess economics, dynamic simulation, risk analysis, combinatorial optimization and operations research to address such challenges (e.g. 1-5). This presentation will show our latest practical applications of such models to industrially-relevant problems related to facility design and capacity sourcing for long-term commercial supply when dealing with processes with either continuous upstream or downstream processes. The results can be translated across a range of products ...