This document discusses the scale up of industrial microbial processes. It begins with an introduction to the importance of biotechnology and scale up. The key points are:
1. Scale up is increasing production size and involves transferring microbial fermentation processes developed at lab scale to large scale for commercial purposes.
2. There are typically two stages of scale up - a pilot plant (100-10,000L fermenters) to translate the lab process and a demonstration plant (10,000-100,000L fermenters) to validate the process for full scale.
3. Successful scale up requires considering factors like inoculum preparation, fermenter design, sterilization, oxygen supply, and foaming
Batch, fedbatch and continuous fermentationDhanya K C
The document discusses different types of fermentation processes including batch, fed-batch, and continuous fermentation. It explains the key characteristics of each type such as whether the system is open or closed, and how substrates and cells are added or removed. The stages of microbial cell growth including lag phase, exponential phase, stationary phase, and death phase are also summarized for batch fermentation.
This document discusses the key components required for microbial growth and fermentation, including carbon, nitrogen, minerals, vitamins and oxygen. It outlines the goals of optimizing fermentation media to maximize product yield while minimizing undesirable byproducts. Finally, it examines various carbon sources, nitrogen sources, minerals, trace elements and antifoaming agents used in fermentation media formulation.
Process scale-up is a critical activity that enables a fermentation process achieved in research and development to operate at a commercially viable scale for manufacturing.
This document discusses single cell proteins (SCP), which are dried cells of microorganisms that can be used as a dietary protein supplement. SCPs are produced using biomass as a raw material and various microorganisms like fungi, algae, and bacteria that are cultured on the biomass. The production involves selecting suitable microorganism strains, fermenting them, harvesting the cells, and processing them for use as a protein supplement in foods. SCPs have advantages like being a renewable source of protein but also have disadvantages like potentially high nucleic acid content.
The document discusses upstream processing in biomanufacturing. Upstream processing involves growing cells in bioreactors to produce target proteins for pharmaceuticals. Key aspects of upstream processing include media preparation and sterilization, inoculum development, and cell culture in bioreactors. The main goal of upstream processing is to provide optimal environmental conditions for cell growth and protein production before downstream processing separates and purifies the target proteins.
This document provides an overview of media formulation for fermentation and bioprocessing. It discusses the types of media, including complex and synthetic media. The key requirements for formulated media are then outlined, including carbon sources, oxygen sources, water, nitrogen sources, minerals, growth factors, and antifoams. Specific examples are given for each requirement. The document emphasizes that media formulation is essential for successful laboratory experiments and manufacturing processes.
This document summarizes the application of computers in fermentation. It discusses the initial use of computers in the 1960s for modeling fermentation processes. Computers are now used for logging process data, analyzing the data, and controlling fermentation processes. Sensors are used to monitor important factors like temperature, pH, dissolved oxygen, and mineral/nutrient levels to provide data inputs for computer control and modeling of fermentation.
Batch, fedbatch and continuous fermentationDhanya K C
The document discusses different types of fermentation processes including batch, fed-batch, and continuous fermentation. It explains the key characteristics of each type such as whether the system is open or closed, and how substrates and cells are added or removed. The stages of microbial cell growth including lag phase, exponential phase, stationary phase, and death phase are also summarized for batch fermentation.
This document discusses the key components required for microbial growth and fermentation, including carbon, nitrogen, minerals, vitamins and oxygen. It outlines the goals of optimizing fermentation media to maximize product yield while minimizing undesirable byproducts. Finally, it examines various carbon sources, nitrogen sources, minerals, trace elements and antifoaming agents used in fermentation media formulation.
Process scale-up is a critical activity that enables a fermentation process achieved in research and development to operate at a commercially viable scale for manufacturing.
This document discusses single cell proteins (SCP), which are dried cells of microorganisms that can be used as a dietary protein supplement. SCPs are produced using biomass as a raw material and various microorganisms like fungi, algae, and bacteria that are cultured on the biomass. The production involves selecting suitable microorganism strains, fermenting them, harvesting the cells, and processing them for use as a protein supplement in foods. SCPs have advantages like being a renewable source of protein but also have disadvantages like potentially high nucleic acid content.
The document discusses upstream processing in biomanufacturing. Upstream processing involves growing cells in bioreactors to produce target proteins for pharmaceuticals. Key aspects of upstream processing include media preparation and sterilization, inoculum development, and cell culture in bioreactors. The main goal of upstream processing is to provide optimal environmental conditions for cell growth and protein production before downstream processing separates and purifies the target proteins.
This document provides an overview of media formulation for fermentation and bioprocessing. It discusses the types of media, including complex and synthetic media. The key requirements for formulated media are then outlined, including carbon sources, oxygen sources, water, nitrogen sources, minerals, growth factors, and antifoams. Specific examples are given for each requirement. The document emphasizes that media formulation is essential for successful laboratory experiments and manufacturing processes.
This document summarizes the application of computers in fermentation. It discusses the initial use of computers in the 1960s for modeling fermentation processes. Computers are now used for logging process data, analyzing the data, and controlling fermentation processes. Sensors are used to monitor important factors like temperature, pH, dissolved oxygen, and mineral/nutrient levels to provide data inputs for computer control and modeling of fermentation.
The document discusses various strategies for recovery and purification of bio-products from fermentation broth. It describes key unit operations like solid-liquid separation techniques like filtration, centrifugation and flocculation to remove cells and debris. Further purification techniques involve precipitation, solvent extraction, ultrafiltration to concentrate and purify the product. Final processing includes crystallization, drying techniques like lyophilization and spray drying to package the purified product. Cell disruption methods including homogenization, bead mills and ultrasonication are also summarized to release intracellular components.
Basic Knowledge about industrial microorganism. why industry choose microorganism rather than chemical. isolation technique of microorganism. source of microorganisms. Process of using microorganism. Disadvantages of using microorganisms in industry. Process of genetic modification of microorganisms. Storage process of microorganism. preservation methods of microorganism. Reculture methods of microorganism.
This document discusses airlift fermenters, which are a type of bioreactor. It provides three key points:
1) Airlift fermenters are pneumatic bioreactors that use gas injection and density gradients to circulate liquids without a mechanical agitator, reducing shear stress and heat generation.
2) There are two main types - internal loop fermenters with a central draft tube, and external loop fermenters with separate circulation channels.
3) Airlift fermenters are commonly used for aerobic processes, producing products like single cell proteins, due to their efficiency and ability to handle fragile cells. They have simple designs but require higher gas pressures and throughputs than stirred
Single cell protein (SCP) refers to edible microorganisms or their extracts used as a protein supplement. SCP can be produced using bacteria, yeast, fungi or algae through fermentation. It has high nutritional value but also has some limitations. Research is focused on improving production methods and addressing issues like high nucleic acid content and digestibility. SCP shows potential as a sustainable protein source but more work is needed before it will be widely accepted as human food.
The document discusses inoculum development and production media for industrial fermentation. It defines inoculum as a culture of microbes used to inoculate production-scale fermentations. Successful fermentations require developing inoculum to an active, healthy state in appropriate density. The document outlines factors that affect fermentation and discusses various media components like carbon sources, nitrogen sources, and trace elements. It also covers inoculum development methods for bacterial and mycelial cultures, preservation techniques, examples of media used for specific inocula, and criteria for a good inoculum.
The document summarizes key aspects of upstream processing in fermentation. The upstream process includes culture isolation and screening to obtain desired microorganisms, inoculum preparation using increasing media volumes to actively grow cultures, and media formulation and sterilization. Primary screening qualitatively determines which microorganisms can produce compounds of interest, while secondary screening characterizes industrially important organisms and determines yield potentials under different conditions to select microbes suitable for industrial use. Important steps in inoculum preparation and considerations for media composition like carbon, nitrogen, minerals and growth factors are also outlined.
This document discusses screening techniques used to isolate microorganisms of interest from a population. It describes primary screening as an initial process to discard many non-useful microbes while detecting a small percentage that may have industrial applications. Secondary screening further tests the capabilities of these isolated microorganisms to determine their real potential value. Some primary screening techniques mentioned include using crowded plates, detecting organic acid production, and screening for antibiotic production. The document also discusses improving crowded plate techniques and the goals and approaches of secondary screening to evaluate a microorganism's potential for industrial use.
This document discusses three main modes of fermentation: batch, continuous, and fed-batch fermentation. Batch fermentation uses a closed system where fresh media is not added and waste is not removed, resulting in changing nutrient and waste concentrations over time. Continuous fermentation uses an open system where fresh media and waste removal occur continuously, maintaining steady-state log phase growth. Fed-batch fermentation uses a semi-closed system where fresh media is added periodically without waste removal, allowing nutrient concentrations to be controlled while volume increases over time.
This document discusses single cell oils (SCO), which are oils and fats produced through the microbial fermentation of sugar-rich media using oleaginous microorganisms like algae, yeasts and fungi. These microorganisms can accumulate up to 40% of their dry cell weight as lipids. The document outlines various microorganisms used for SCO production, cultivation methods like photobioreactors and open ponds, and extraction techniques for oils from microalgae including physical, chemical and enzymatic methods. Key advantages of SCO are the rapid growth and high yields of oleaginous microorganisms without requiring farmland.
Strain development techniques of industrially important microorganismsMicrobiology
Strain improvement and development involves manipulating microbial strains to enhance their metabolic capacities for biotechnology applications. Targets of improvement include rapid growth, genetic stability, non-toxicity, large cell size, ability to use cheaper substrates, increased productivity, and reduced cultivation costs. Methods for optimization include modifying environmental conditions, nutrition, mutagenesis, transduction, conjugation, transformation, and genetic engineering. Common industrial microorganisms are bacteria such as Bacillus subtilis and yeasts such as Saccharomyces cerevisiae.
This document discusses solid state fermentation and provides details about the process. It describes that solid state fermentation involves fermentation using solids in the absence of free water, though some moisture is needed. Microorganisms like fungi grow on the surface of solid substrates to produce things like enzymes, organic acids, and flavors. Agriculture wastes are commonly used as substrates. Fungi like Trichoderma and Aspergillus species are widely used to produce hydrolytic enzymes. Tray fermenters and rotating drum reactors are two common types of bioreactors used in solid state fermentation.
This document provides an overview of bioprocess engineering. It defines a bioprocess as a process that uses living cells or their components to produce desired products. Bioprocess engineering deals with designing equipment and processes for producing items like pharmaceuticals, chemicals, and polymers using bioprocesses. The document then describes the major components of bioprocesses, including upstream processing, fermentation, and downstream processing. It provides examples of products produced through various bioprocesses.
The document discusses the concepts, history, and development of industrial microbiology. It describes how industrial microbiology uses microorganisms to produce industrial products at large scales. The history is divided into five phases from early uses of fermentation in ancient times to the current biotechnology period. Key developments include Pasteur's discoveries of microbial roles in fermentation, the era of antibiotic discovery including penicillin, and recent advances in biotechnology using genetic engineering. Microbes now have important industrial applications in producing metabolites, chemicals, and pharmaceuticals.
This document discusses the development of inoculum for industrial fermentation processes. It defines inoculum as a mixture of cultured microbes and the media they are growing in. The key steps in inoculum development are preparing a suitable growth media, maintaining optimal pH and nutrient levels, and conducting growth in stepwise increasing volumes. Examples of common inoculum media compositions are provided for vitamin and bacterial insecticide production processes. Developing high quality inoculum is important for efficiently adapting cultures to fermentation conditions.
Bioprocess development and technology-Introduction,History of bioprocess,Milestones of Bioprocess development,Bioprocess development,Impact on Biotechnology
Scaling up industrial microbial processes is a complex endeavor that requires careful planning and execution to be successful. It involves increasing laboratory-scale processes to full commercial production levels over many years and at a high financial cost. If not approached properly, scale-up can lead to underperformance, delays, and project failure. To scale up successfully, one must begin with a clear vision of the final commercial process, be diligent in considering all critical details, and prepare for unexpected challenges that may arise.
The uploaded Power point presentation is of Industrial Pharmacy-II Unit-I (Topic - Pilot Plant Scale up Techniques). ppt is very useful for student of B.pharmacy
The document discusses various strategies for recovery and purification of bio-products from fermentation broth. It describes key unit operations like solid-liquid separation techniques like filtration, centrifugation and flocculation to remove cells and debris. Further purification techniques involve precipitation, solvent extraction, ultrafiltration to concentrate and purify the product. Final processing includes crystallization, drying techniques like lyophilization and spray drying to package the purified product. Cell disruption methods including homogenization, bead mills and ultrasonication are also summarized to release intracellular components.
Basic Knowledge about industrial microorganism. why industry choose microorganism rather than chemical. isolation technique of microorganism. source of microorganisms. Process of using microorganism. Disadvantages of using microorganisms in industry. Process of genetic modification of microorganisms. Storage process of microorganism. preservation methods of microorganism. Reculture methods of microorganism.
This document discusses airlift fermenters, which are a type of bioreactor. It provides three key points:
1) Airlift fermenters are pneumatic bioreactors that use gas injection and density gradients to circulate liquids without a mechanical agitator, reducing shear stress and heat generation.
2) There are two main types - internal loop fermenters with a central draft tube, and external loop fermenters with separate circulation channels.
3) Airlift fermenters are commonly used for aerobic processes, producing products like single cell proteins, due to their efficiency and ability to handle fragile cells. They have simple designs but require higher gas pressures and throughputs than stirred
Single cell protein (SCP) refers to edible microorganisms or their extracts used as a protein supplement. SCP can be produced using bacteria, yeast, fungi or algae through fermentation. It has high nutritional value but also has some limitations. Research is focused on improving production methods and addressing issues like high nucleic acid content and digestibility. SCP shows potential as a sustainable protein source but more work is needed before it will be widely accepted as human food.
The document discusses inoculum development and production media for industrial fermentation. It defines inoculum as a culture of microbes used to inoculate production-scale fermentations. Successful fermentations require developing inoculum to an active, healthy state in appropriate density. The document outlines factors that affect fermentation and discusses various media components like carbon sources, nitrogen sources, and trace elements. It also covers inoculum development methods for bacterial and mycelial cultures, preservation techniques, examples of media used for specific inocula, and criteria for a good inoculum.
The document summarizes key aspects of upstream processing in fermentation. The upstream process includes culture isolation and screening to obtain desired microorganisms, inoculum preparation using increasing media volumes to actively grow cultures, and media formulation and sterilization. Primary screening qualitatively determines which microorganisms can produce compounds of interest, while secondary screening characterizes industrially important organisms and determines yield potentials under different conditions to select microbes suitable for industrial use. Important steps in inoculum preparation and considerations for media composition like carbon, nitrogen, minerals and growth factors are also outlined.
This document discusses screening techniques used to isolate microorganisms of interest from a population. It describes primary screening as an initial process to discard many non-useful microbes while detecting a small percentage that may have industrial applications. Secondary screening further tests the capabilities of these isolated microorganisms to determine their real potential value. Some primary screening techniques mentioned include using crowded plates, detecting organic acid production, and screening for antibiotic production. The document also discusses improving crowded plate techniques and the goals and approaches of secondary screening to evaluate a microorganism's potential for industrial use.
This document discusses three main modes of fermentation: batch, continuous, and fed-batch fermentation. Batch fermentation uses a closed system where fresh media is not added and waste is not removed, resulting in changing nutrient and waste concentrations over time. Continuous fermentation uses an open system where fresh media and waste removal occur continuously, maintaining steady-state log phase growth. Fed-batch fermentation uses a semi-closed system where fresh media is added periodically without waste removal, allowing nutrient concentrations to be controlled while volume increases over time.
This document discusses single cell oils (SCO), which are oils and fats produced through the microbial fermentation of sugar-rich media using oleaginous microorganisms like algae, yeasts and fungi. These microorganisms can accumulate up to 40% of their dry cell weight as lipids. The document outlines various microorganisms used for SCO production, cultivation methods like photobioreactors and open ponds, and extraction techniques for oils from microalgae including physical, chemical and enzymatic methods. Key advantages of SCO are the rapid growth and high yields of oleaginous microorganisms without requiring farmland.
Strain development techniques of industrially important microorganismsMicrobiology
Strain improvement and development involves manipulating microbial strains to enhance their metabolic capacities for biotechnology applications. Targets of improvement include rapid growth, genetic stability, non-toxicity, large cell size, ability to use cheaper substrates, increased productivity, and reduced cultivation costs. Methods for optimization include modifying environmental conditions, nutrition, mutagenesis, transduction, conjugation, transformation, and genetic engineering. Common industrial microorganisms are bacteria such as Bacillus subtilis and yeasts such as Saccharomyces cerevisiae.
This document discusses solid state fermentation and provides details about the process. It describes that solid state fermentation involves fermentation using solids in the absence of free water, though some moisture is needed. Microorganisms like fungi grow on the surface of solid substrates to produce things like enzymes, organic acids, and flavors. Agriculture wastes are commonly used as substrates. Fungi like Trichoderma and Aspergillus species are widely used to produce hydrolytic enzymes. Tray fermenters and rotating drum reactors are two common types of bioreactors used in solid state fermentation.
This document provides an overview of bioprocess engineering. It defines a bioprocess as a process that uses living cells or their components to produce desired products. Bioprocess engineering deals with designing equipment and processes for producing items like pharmaceuticals, chemicals, and polymers using bioprocesses. The document then describes the major components of bioprocesses, including upstream processing, fermentation, and downstream processing. It provides examples of products produced through various bioprocesses.
The document discusses the concepts, history, and development of industrial microbiology. It describes how industrial microbiology uses microorganisms to produce industrial products at large scales. The history is divided into five phases from early uses of fermentation in ancient times to the current biotechnology period. Key developments include Pasteur's discoveries of microbial roles in fermentation, the era of antibiotic discovery including penicillin, and recent advances in biotechnology using genetic engineering. Microbes now have important industrial applications in producing metabolites, chemicals, and pharmaceuticals.
This document discusses the development of inoculum for industrial fermentation processes. It defines inoculum as a mixture of cultured microbes and the media they are growing in. The key steps in inoculum development are preparing a suitable growth media, maintaining optimal pH and nutrient levels, and conducting growth in stepwise increasing volumes. Examples of common inoculum media compositions are provided for vitamin and bacterial insecticide production processes. Developing high quality inoculum is important for efficiently adapting cultures to fermentation conditions.
Bioprocess development and technology-Introduction,History of bioprocess,Milestones of Bioprocess development,Bioprocess development,Impact on Biotechnology
Scaling up industrial microbial processes is a complex endeavor that requires careful planning and execution to be successful. It involves increasing laboratory-scale processes to full commercial production levels over many years and at a high financial cost. If not approached properly, scale-up can lead to underperformance, delays, and project failure. To scale up successfully, one must begin with a clear vision of the final commercial process, be diligent in considering all critical details, and prepare for unexpected challenges that may arise.
The uploaded Power point presentation is of Industrial Pharmacy-II Unit-I (Topic - Pilot Plant Scale up Techniques). ppt is very useful for student of B.pharmacy
The document discusses pilot plant scale up techniques for pharmaceutical manufacturing. It begins by defining key terms like pilot plant, scale-up, and objectives of pilot plant studies. It then describes the steps involved in pilot plant scale up for solid oral dosage forms including granulation, drying, milling, blending, compression, and coating processes. Specific considerations for scaling up each unit operation are discussed. The document also covers scale up of liquid oral dosage forms and the equipment used. Finally, it lists important documentation required for pilot plant scale up including standard operating procedures, batch records, specifications, and guidelines like SUPAC.
This document outlines the process and considerations for pilot plant scale-up of pharmaceutical manufacturing. It defines a pilot plant as transforming a lab-scale formula into a viable product through developing a reliable manufacturing procedure. The objectives of a pilot plant are to produce stable dosage forms, review equipment, establish production guidelines and controls, evaluate and validate processes and equipment, and determine a master manufacturing formula. Key steps involve reviewing the formula, approving raw materials, selecting appropriate sized equipment, determining production rates, developing standard operating procedures, and conducting stability testing. Personnel with both scientific and engineering knowledge are needed, and facilities must allow for physical testing, equipment, raw materials storage, and record keeping. Adherence to good manufacturing practices is also important for a
This document discusses pilot plant scale-up techniques for pharmaceutical manufacturing. It defines a pilot plant and scale-up process. The key steps in scale-up involve conducting laboratory and smaller pilot studies, designing and constructing a pilot plant, evaluating results to make corrections, and deciding whether to proceed to full-scale production. General considerations for a pilot plant include personnel requirements, equipment, production rates, process evaluation, and ensuring product stability and uniformity. GMP must also be followed in areas like process validation and documentation.
This document discusses pilot plant scale-up techniques for pharmaceutical manufacturing. It defines a pilot plant and scale-up process. The key steps in scale-up involve conducting laboratory and smaller pilot studies, designing and constructing a pilot plant, evaluating results to make corrections, and deciding whether to proceed to full-scale production. General considerations for a pilot plant include personnel requirements, equipment, production rates, process evaluation, and ensuring product stability and uniformity. GMP must also be followed in areas like process validation and documentation.
This document discusses pilot plant scale-up techniques for pharmaceutical manufacturing. It defines a pilot plant and scale-up process. The key steps in scale-up involve conducting laboratory and smaller pilot studies, designing and constructing a pilot plant, evaluating results to make corrections, and deciding whether to proceed to full-scale production. General considerations for a pilot plant include personnel requirements, equipment, production rates, process evaluation, and ensuring product stability and uniformity. GMP must also be followed in areas like process validation and documentation.
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
Pilot plant scaleup techniques used in pharmaceutical manufacturingSunil Boreddy Rx
The document discusses pilot plant scale-up techniques. It defines a pilot plant as transforming a lab scale formula into a viable product through developing a reliable manufacturing process. The objectives of pilot plant studies are to examine a formula's ability to withstand scale-up, identify critical process aspects, and provide manufacturing guidelines to avoid problems. Key considerations for pilot plants include personnel requirements, equipment selection, production rates, process evaluation, and product stability testing.
The document discusses pilot plant scale-up techniques. It defines a pilot plant as transforming a lab scale formula into a viable manufacturing process. The objectives of a pilot plant include testing the process before committing funds to full production and examining the formula's ability to withstand scaling. Key steps in scale-up involve defining product economics, conducting lab and planning studies, evaluating rate-controlling steps, designing and constructing a pilot plant, and evaluating results. General considerations for scale-up include personnel requirements, equipment selection, production rates, and process evaluation.
The document discusses pilot plant scale-up techniques. A pilot plant allows examination of a product and process on an intermediate scale before committing to full-scale production. It is important for identifying critical process parameters, producing samples for evaluation, and providing data to determine feasibility of full-scale production. The document outlines general considerations for pilot plant setup and operation including personnel requirements, equipment needs, production rates, process evaluation, and GMP compliance.
This document discusses the purpose and operation of a pilot plant in the pharmaceutical industry. It states that a pilot plant allows investigation of a product and process on an intermediate scale before large-scale production is committed to. This helps evaluate results from laboratory studies, produce small quantities of product for testing, and provide data to determine if full-scale production is viable. The document outlines considerations for personnel, space, equipment, raw materials, and production rates in setting up a pilot plant.
Introduction, Objective; Significance; General consideration; Pilot plant scale up technique for solid, liquid and semi solids; SUPAC Guidelies; Introduction to platform technology
This document discusses techniques for scaling up pilot plant operations in the pharmaceutical industry. It begins with definitions of key terms and explains the significance of pilot plants in permitting examination of formulas at an intermediate scale. The document outlines general considerations for pilot plant operations, including personnel requirements, equipment used, production rates, and process evaluation. It also covers master manufacturing procedures, product stability testing, and GMP compliance. Advantages are given as personnel can observe scale up runs and quality materials can be accessed, while disadvantages include reduced interaction between formulators and production staff.
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
1. A pilot plant allows for transforming a lab scale formula into a viable product by developing reliable manufacturing procedures at an intermediate scale. This helps identify any issues before committing to full-scale production.
2. Key objectives of a pilot plant include evaluating results from laboratory studies, producing small quantities of product for testing, and determining parameters for full-scale production.
3. Important considerations for pilot plant development include the type and size of equipment needed, proper location, staffing requirements, and ensuring compliance with Good Manufacturing Practices.
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Scale up of industrial microbial processes
1. SCALE UP OF INDUSTRIAL MICROBIAL
PROCESSES (IM 601)
SUBMITTED TO
JANE CLARYN BENJAMIN MA’AM
SUBMITTED BY (GROUP IV)
SHUBHAM RANJAN 18BTFT034
KULDEEP GEHLOT 18BTFT035
ADITI PATIDAR 18BTFT036
SMRITI SINGH 18BTFT038
MANISHA SALONI 18BTFT041
PRASHANT SAINI 18BTFT042
SMITA KUMARI 18BTFT043
KAKUMANU SANJYOPTHA 18BTFT045
TANYA VATS 18BTFT048
2. TABLE OF CONTETS
1. INTRODUCTION
2. WHAT IS SCALE UP AND WHY DOES IT MATTER
3. STAGES OF SCALE UP FERMENTATION
4.KEY CONSIDERATION FOR FERMENTATION SCALE UP
5. ROAD MAP FOR SUCCESSFUL SCALE-UP
6.KEY CHALLENGES AND IMPROVEMENT IN MICROBIAL SCALE UP PROCESSES
7. FERMENTATION PROCESS SCALE-UP INCLUDE
8.WHAT ARE THE OPPORTUNITIES IN SCALE UP OF INDUSTRIAL MICROBIAL PROCESS CONCLUSION
3. 1. INTRODUCTION
The importance of biotechnological production is increasing all over the world. It’s importance increases as
it is connected with health and food industry directly or indirectly. So overall it is a billion dollar industry.
The way these impressive economic biotech figures can be achieved is either to develop completely new
bioproducts and to successfully launch them on the market or to expand existing production capacities
against the competition of market forces.
The concerted approach of metabolic engineering, synthetic biology and systems biology is promising to
develop optimized processes in lab-scale, they still need to be transferred into large-scale without reduction
of sensitive performance parameters.
4. Notably, large-scale performance losses are not unusual. The explanation of scale-up mechanisms for
preventing unwanted performance losses is not only an academic goal but also an economic necessity.
Microbial fermentation processes play a critical role in many important industrial applications. In various
applications, fermentation processes are utilized to produce final product, convert substrates, catalyze
reactions or simply make mass biological materials.
This project covers a lot of information related to scale up industrial microbial processes like principles
for process scale up, key considerations for fermentation scale up, road map, challenges, improvements
and opportunities.
5. 2. WHAT IS SCALE UP AND WHY DOES IT MATTER
The successful startup and operation of commercial size unit is design and operating procedure are in the
path based upon experimentation and demonstration it is smaller scale.
Scale-up is increasing something in size, amount, or production. Microbial processes involve cultivation of
microbes in bioreactors (also referred to as fermentors) to produce a product, as well as the subsequent
recovery and purification of the product and disposal of associated wastes.
Scale-up of microbial processes is undertaken typically for a commercial purpose, specifically to provide
product benefits to customers and to generate a financial return for investors.
6. It serves to minimize the risk of a large capital investment in the full-scale manufacturing plant by further
validating the process, the supply chain (from raw materials to commercial product application), and market
demand
If the degree of novelty is low, then the demonstration plant may be skipped. For the remainder of the
article, we will use ‘pilot’ in reference to both pilot and demo scales.
The financial investment to scale up a microbial process to manufacturing scale is usually greater than the
cost to develop the production microbe and lab-scale process
The financial risk is high, so deterioration in process performance during scale-up will be costly and
disruptive, potentially even leading to project failure.
So, in scaling up microbial processes, it is clearly impactful to get it right and to get it right the first time.
7. 3. STAGES OF SCALE UP FERMENTATION
Scale-up of large industrial processes is preferably done in two stages if there is a high degree of novelty in
the process and/or the commercial product. The first stage is a pilot plant (pilot scale) with 100–10,000 L
fermenters and matched downstream equipment. Its purpose is to translate the lab-scale process into a
realistic scaled-down version of the manufacturing process.
In most cases, the process is not fully integrated; i.e. each individual unit operation is operated batch-wise.
The second stage of scale-up is a demonstration plant (demo scale) with 10 000–100 000 L fermenters and
matched downstream. It serves to minimize the risk of a large capital investment in the full-scale
manufacturing plant by further validating the process, the supply chain and market demand.
8. 3.1 Guiding principles for process scale up
The authors have contributed to the commercialization of a variety of industrial microbial processes,
including first-of-a-kind projects, from early stage R&D to scale-up to manufacturing support .
There are three guiding principles that are critical to the successful scale-up of industrial microbial
processes.
1.Begin with the end in mind
The challenge is having a realistic and accurate view of what the end looks like especially when
it’s a first-of-a-kind process. One cannot simply enlarge lab-scale equipment and duplicate lab
scale conditions at large-scale.
9. Without an understanding of large-scale equipment and how scale dependent parameters change, a
project is likely to get into big trouble.
Instead, beginning with the end in mind, a skilled project team that really understands large scale
processes prepares a detailed conceptual design of the envisioned manufacturing process and plant before
the first lab experiments are done.
Use the conceptual design to provide early guidance to the experimental R&D program on process
viability and key scale and economic parameters. Then regularly update the design as your experimental
program produces new learnings.
10. 2. Be diligent in the details
Unfortunately, we’ve seen all kinds of oversights and shortcuts during process scale-up, with
consequences ranging from disruptive to catastrophic.
On the other hand, with close attention given to critical details, microbial processes can be scaled
up with minimal unpleasant surprises.
Ultimately, this will reward stakeholders with a safe, reliable manufacturing plant that meets or
exceeds its financial objectives.
11. 3. Prepare for the unexpected
Common examples include utility interruptions, microbial contamination, variable raw material
quality, fouling of process equipment, equipment failure and unexpected poor process
performance at scale.
Prioritize based on risk magnitude and prepare a detailed risk mitigation plan.
For high magnitude risks relating to process upsets, design lab/pilot studies to assess the impact
on process performance and develop a detailed process upset response plan to inform the plant
operations team of the proper mode of action if an upset does occur.
12. 4.KEY CONSIDERATION FOR FERMENTATION SCALE UP
Poor fermentation performance at large-scale is almost always considered a priority scale-up risk. This is
because fermentation is usually the costliest process step, both in terms of variable costs (raw materials
and utilities) and capital investment. Fermentation is also a complex unit operation.
There are many parameters that impact performance, and most of these are subject to change
during scale-up.
A. Preparation of
inoculum
B. Tank/Fermenter
Aspect Ratio
C. Sterilization
and cleaning of
the tank
D. Proper supply
of oxygen and
agitation
E. Control
of foaming
13. A. Preparation of inoculum – is the first and most important parameter because the inoculum size, density
and the phase in which the inoculum is will determine the yield and productivity.
14. B. Tank/Fermenter Aspect Ratio – the capacity of the fermenter in the Industries used are large . So the size
and capacity of the fermenter should be kept in mind while applying the other methods and processes.
15. C. Sterilization and cleaning of the tank – the tank and other equipments should be cleaned and sterilized to
ensure the protection of media inside the fermenter from any contamination
D. Proper supply of oxygen and agitation – The demand for oxygen in SUF is always more and it is
necessary to keep the level of oxygen more than the critical level and the supplied oxygen and air should be
thoroughly mixed inside the fermenter
E. Control of foaming – during the process foams generated might spill out and may contaminate the Product
inside the fermenter so antifoaming agent should be used.
F. Other factors such as pH, removal of heat and pressure
16. 5. ROAD MAP FOR SUCCESSFUL SCALE-UP
The scale-up journey starts by imagining the desired outcome a robust full-scale manufacturing plant that
meets its commercial objectives (schedule, cost, and quality) begin with the ending mind.
All of this is remembered at the beginning of a project in the form of a detailed, written charter that is
updated as the program progresses from R&D proof-of-concept through process development and
eventually deployment.
But in the case of fermentation, large-scale conditions can usually be adequately simulated in stirred lab
fermenters with the implementation of Some custom control hardware and software.
17. A fully integrated process, including recycle streams, can be operated for an extended period with fully
representative industrial equipment and materials. Alternative equipment designs and suppliers can be
evaluated.
The future large-scale plant operating team can be trained; from the team’s pilot experience, they will know
the process works and will log valuable experience in addressing process upsets. Pilot plant data and
operating know-how are used to improve the large-scale plant design.
Large quantities of product can be produced for customer evaluation in the end-use applications, which
builds customer relationships, confidence and demand for the commercial plant output.
18. As a Results, it can be tempting to skip this step or to pilot only selected unit operations for a short time.
Experience has proven this to be unwise; the downside far outweighs the modest upside.
Design of the large-scale manufacturing plant should be based on data generated in the pilot plant. It is also
important to factor in the outlook for future technology improvements. But avoid the temptation to design
the large-scale plant for a process that has not been validated at pilot scale.
Whether you intend to build, own and operate your own plant or license your technology, it is crucial to
provide technincal support during all phases of the project, including engineering design, construction,
commissioning and start-up.
19.
20. 6.KEY CHALLENGES AND IMPROVEMENT IN MICROBIAL
SCALE UP PROCESSES
Regardless of how well you prepare, there will be issues that arise during scale-up. Common examples
include utility interruptions, microbial contamination, variable raw material quality, fouling
of process equipment, equipment failure and unexpected poor process performance at scale.
Improvements mean that the focus now is not so much on capacity as on purification. The big challenges
now lie in downstream processing. “There are lots of ideas out there,”. In both downstream processing and in
other stages of manufacture, scale up can present a challenge but one that can be met by employing the right
technologies.
21. Scale up generally involves taking a lab-scale procedure and replicating it as closely as possible to get larger
amounts of product as specified either by a client or the regulatory authorities typically in a fermenter.
22. 6.1 SOME OF THE ISSUSES OFFERMENTATION SCALE UP PROCESSES
CHROMATOGRAPHY
The use of chromatography in purification can lead to some challenges in scale up, which may be solved by
new approaches.
Mixed-mode Hypercell media can exploit different mechanisms of interaction with a target protein.
FILTRATION
Filtration is necessary at many stages of a manufacturing process, so an understanding of
filterability the filtration behavior of a solution is crucial.
Filterability testing can be used to determine the capacity of a filter system with the aim of
determining the filter area that would be needed to process a batch without blocking the filter
upon scale up.
23. HYDROCYCLONE
Many industries have been looking at a new cell separation technology based upon the
Hydrocyclone, which can be used as a perfusion system in large-scale animal cell culture.
The hydrocyclone works like an inverted fixed-wall centrifuge without a rotating shaft.
24. 7. FERMENTATION PROCESS SCALE-UP INCLUDE
7.1 Seed train sale-up strategy
The purpose of a seed train is to propagate cells to a desired mass for inoculation into the production
bioreactor.
The traditional seed train includes thawing a vial and inoculating into shaker flasks for a certain number of
stages with increasing flask size, and may include stainless steel reactors.
The guiding principle for a seed train scale up is to minimize the number of stages for entire seed train,
maintain robust growth and finally prevent any negative impact of extended generations to productivity and
quality.
25. Typical studies of seed train scale-up may include:-
1.Vial thaw conditions: this may include temperature and time between thaw and inoculation
2.Inoculation ratio: for microbes,0.1to 5% is commonly used. However, overall process robustness needs to
be demonstrated with the inoculation ratios.
3.Seed train media: Usually, seed train media are optimized to support growth, rather than product
expression, in a batch mode.
4.Genetic stability and production stability during the seed train process: This requires studies with an
extended duration, beyond that estimated to be required for generation at the production scale.
26.
27. 7.2 Production fermentation scale-up
The essence of scale-up of a fermentation process is to demonstrate fermentation production at large scale
resulting in the same productivity and quality as that developed at small scale.
One of the outcomes of a process scale-up is to finalize a detailed large scale process description with
settings of all operational parameters and their ranges at scale.
The scaled-up fermentation has to be demonstrated with a certain number of runs for consistency and
statistical significance. To achieve these goals, one have to take the following steps
Identify linear scale-up parameters
Temperature
Ph
Pressure
Dissolved oxygen(DO)
Air flow rate
28. 8.WHAT ARE THE OPPORTUNITIES IN SCALE UP OF
INDUSTRIAL MICROBIAL PROCESS
Opportunities in scale up of Industrial microbial process
Many researches were done and the analysis showed potential target genes associated with increased ATP
demand for metabolic engineering. Such approach was previously used by the same research team for
re‐designing an E. coli strain with increased glucose uptake capacity to cope with nutrient‐limiting
conditions typically found in industrial fed‐batch bioprocess .
These new findings point out that predicting microbial physiological responses to environmental
fluctuations remains a challenge but also that there are vast potential applications.
29. This then is a good opportunity for presenting a modernized version of the scale‐down approach, i.e. an
outlook on the different items that have to be considered for a better understanding of bioprocess scale‐up
and the behaviour of cell populations under industrial process‐related conditions .
The bioprocess industry more than ever needs new, efficient and sustainable routes to manufacture
bio‐products. Bioprocesses use the power and versatility of nature via microorganisms that make the
bio‐products from renewable feedstocks. These microorganisms today can be extensively re‐programmed
into efficient cell factories.
30.
31. CONCLUSION
Scaling up industrial microbial processes for commercial production is a high stakes endeavor ,requiring time
and investment often exceeding that for laboratory microbe and process development.
The bio‐economy is in transit from innovation to commercialization. The bioprocess industry is expected to
increasingly deliver bio‐products to the market, in large amounts, at high quality and at competitive cost
levels. This requires flawless start‐up of new large‐scale bioprocesses and continuous improvement of
running processes.
32. Process scale up ,in a broad sense, is a critical activity that enables a fermentation process achieved in
research and development to operate at a commercially viable scale for manufacturing .A successful scale up
involves many aspects of successful preparation and planning beyond pure process scale up technology.