Upstream and downstream processing

The bioprocess can be explained as a particular process that utilizes complete living cells or
some of their cellular components to get wanted items. The process is used in the creation of
nourishments, pharmaceuticals, flavors, energy, and synthetic concoctions with the guidance
of a biocatalyst. A catalyst in bioprocessing can be microorganisms, plants, or creature cells
in a bioreactor.
Alongside, it includes hereditary designing for the control of animals, plants, and
microorganisms. Downstream handling is required to expel debasements, mass volume
decrease, and concurrent convergence of the ideal item from the bioreactor.
Protein recuperation is touchy to working conditions because their capacity relies upon the
honesty of the sensitive 3D tertiary structure.
What is Bioprocessing?
 Any process that uses complete living cells or their components (e.g., bacteria,
enzymes, chloroplasts) to obtain desired products is referred to as bioprocessing.
 Bioprocessing is also essential to the production of renewable biofuels like ethanol
and biodiesel, therapeutic stem cells, gene therapy vectors, and new vaccines, among
other emerging industries and technologies.
 Bioprocessing includes two important processes - Upstream and downstream
processes.
Cell Treatment Bioprocessing
Cell treatment bioprocessing is an order that combines the fields of cell treatment and
bioprocessing. Cell treatment bioprocessing aims to build up reproducible and sturdy
manufacturing procedures to produce remedial cells. Commercially significant bioprocesses
can:
 Generate items to keep up the entirety of the quality gauges of biopharmaceutical
drugs
 It can also offer clinical and industrial measures of remedial cells all through different
phases of improvement.
 Control the expense of merchandise (CoGs) of the last medication item.
Upstream Bioprocessing
 The process of converting raw materials into a form that can be used in a biologic
manufacturing process is known as upstream bioprocessing.
  Harvesting and purifying natural products, culturing cells, and producing recombinant
proteins are all examples of this.
 Upstream bioprocessing's goal is to create a high-quality starting material for
downstream bioprocessing.
The upstream process is one of the two main parts of a bioprocess. It includes the initial steps
of a fermentation process. The preparation of microorganisms is the first step of upstream
bioprocessing. The desired microbes should be isolated and selected for the bioprocess. Then
they should be cultured in a suitable growth medium. Medium preparation is the second step.
Optimal conditions, together with the nutrients, are supplied for the growth and multiplication
of microorganisms inside a bioreactor.
Downstream Bioprocessing
 The term "downstream bioprocessing" refers to the steps that take place after the
initial bioprocessing steps, which involve the production of a biological agent.
 There are three main steps involved in downstream processing- Purification,
Formulation, and Storage of the agent.
Downstream bioprocessing refers to the several final steps of a bioprocess that
involve product harvest. The downstream process starts when the product
development is completed. The steps include extraction, purification, and packaging
of the final bioproduct of the bioprocess. Downstream bioprocessing is also known
as product recovery. Amino acids, antibiotics, organic acids, vitamins, and vaccines
are some of the bioproducts resulting from a bioprocess. The desired quality of the
bioproduct is achieved during the downstream process. Volatile products can be
purified using a distillation process. Moreover, biomass separation can be done by
centrifugation. Therefore, the stages involving separation, extraction, purification, and
polishing belong to downstream bio processing.
The downstream process involves the following steps-
a. Elimination of Insolubles - By soaking a sample of the material in a solvent, insoluble
impurities are removed. Insoluble impurities will sink to the bottom of the solvent, while the
rest of the material will dissolve. After that, the solvent can be poured off, leaving behind the
insoluble impurities.
b. Isolation of Product - Product isolation is a chemical engineering technique for isolating a
product from a mixture. The product is extracted using a solvent after the mixture is placed in
a container. The product is then isolated after the solvent has been removed.
c. Product Purification - The removal of impurities from a product is known as purification.
Distillation, chromatography, and crystallization are some of the methods that can be used to
accomplish this. Purification aims to create a product that is free of contaminants and pure.
d. Polishing of Product - The product will be polished after it has been cut to remove any
scratches or blemishes that occurred during the cutting process.

Scale up of Fermentation Processes

Definition: - Scale up means the art for designing of large scale apparatus or full size plant
(prototype) using the data obtained from the laboratory studies

Objectives: - To provide master manufacturing formula

• To identify the critical features of the process

• Evaluation, Validation and Finalization of process

• Guidelines for production and process control

• Review of the processing equipment

• To produce physically and chemically stable products.

Requirements for scale up process

• Personnel Requirements

• Space Requirements

• Administration and Information Process

• Physical Testing Area

• Standard Pilot-plant Equipment Floor Space

• Storage Area

• Review of Formula

• Raw materials

• Equipment
• Production rates

• Process Evaluation

• Preparation of Master Manufacturing Procedures

• Product Stability and Uniformity