What is a platform process?

What is a platform process?

A platform process is a production process suitable for the manufacture of a group of related products in a defined production system.

What is cell culture process development?

Cell culture process development starts with cell line generation and selection, followed by process and media optimization in small scale systems, including 96-well plates, shaker flasks, and bench-scale bioreactors, for high throughput screening purposes.

What is upstream cell culture?

The upstream process encompasses the initial transfections of a gene of interest into host cells, the cloning of cell lines with desirable characteristics (eg, high productivity), and subsequent scale-up to large-scale manufacture.

How are monoclonal antibodies produced in CHO cells?

Establishing stable Chinese Hamster Ovary (CHO) cells producing monoclonal antibodies (mAbs) usually pass through the random integration of vectors to the cell genome, which is sensitive to gene silencing. One approach to overcome this issue is to target a highly transcribed region in the genome.

What is meant by platform development?

Platform development means different things to different people depending on their role or the product they are developing. Therefore, the term platform can be used in several different contexts when talking about technology or app development, and this undoubtedly causes confusion and issues with miscommunication.

What is a selection platform?

A platform selection project is when a trusted and unbiased partner evaluates multiple competing technologies to identify what solution will work best for a business’s needs.

What are the 3 types of cell culture?

Cells cultured in the lab can be classified into three different types: primary cells, transformed cells, and self-renewing cells.

What are the stages of cell culture?

Another important factor to keep in mind is the phase of proliferation that the cells are in. There are four phases: lag, log, stationary and decline (29).

What is difference between upstream and downstream?

Simply put, upstream works include the exploration and production of crude oil and natural gas, whilst downstream refers to the processes applied after extraction through to it being delivered to the customer in whatever format required.

What is upstream and downstream process?

Upstream refers to the material inputs needed for production, while downstream is the opposite end, where products get produced and distributed.

Why are CHO cells used?

The Advantages of CHO Cells

Grow well in suspension and as adherent culture, rendering the cells ideal for GMP procedures. Their tolerance to variations in pH, oxygen levels, temperature or pressure make them the ideal cell for large-scale culture. High recombinant protein yields and specific productivity.

Are monoclonal antibodies produced from cell lines?

Cell line development is a critical step in the process of generating biopharmaceutical molecules, such as monoclonal antibodies.

What is the main purpose of platform?

A platform is a group of technologies that are used as a base upon which other applications, processes or technologies are developed. In personal computing, a platform is the basic hardware (computer) and software (operating system) on which software applications can be run.

What is an example of a platform?

An example of a platform is a raised surface next to a train track that you stand on while you wait for the train. An example of a platform is a graduation where you are asked to give the speech; a platform for your ideas. Windows or OSX (mac) are examples of a computer platform.

What is a blended platform?

A blended learning platform is the combination of hardware, software, scheduling, and logistics that make up a learning program that includes online instruction or teaching supplemented with technology. Successful implementation of a blended learning platform requires a planned strategy of steps in a particular order.

How do I choose a technology platform?

5 Things to Consider When Choosing a Tech Stack

  1. Personal Requirements. You need to choose a technology based on the problem you want to solve.
  2. Scope of Project. Small-scale projects are generally faster to deliver and not necessarily require advanced technologies and frameworks.
  3. Time to Market.
  4. Scalability.
  5. Security.

What are different types of cell culture techniques?

There are two cell culture techniques to grow cells in culture, as monolayers on an artificial substrate (i.e., adherent culture) or free-floating in culture medium (suspension culture).

Why DMSO is used as Cryoprotectant?

DMSO (Dimethyl Sulfoxide) is a polar, aprotic organic solvent that is commonly used as a cryoprotectant because of its membrane penetrating and water displacement properties. It is added to cell culture media to reduce ice formation and thereby prevent cell death during the freezing process.

What is meant by downstream processing?

Downstream processing refers to the recovery and the purification of biosynthetic products, particularly pharmaceuticals, from natural sources such as animal tissue, plant tissue or fermentation broth, including the recycling of salvageable components as well as the proper treatment and disposal of waste.

What is upstream and downstream processing?

Upstream & Downstream Processing. The production of active pharmaceutical ingredients (API) of biopharmaceuticals typically starts with generation of the API via living cells known as the upstream process, followed by purification of the target API, or the downstream process.

Is bioreactor upstream or downstream?

The entire process up to the extraction of the product from the bioreactor comes under the upstream process, while steps such as extraction, purification, quality checking, and packaging, etc., which are done after the fermentation process, comes under the downstream process.

What are the stages of bioprocessing?

Different stages associated with bioprocess technology include substrates and media preparation, biocatalyst selection and optimization, volume production, downstream processing, purification, and final processing.

Why are BHK 21 cells used?

The BHK-21 cells are useful for transformations and for stable and temporary transfections. BHK cells are also used to study viral infections.

What media is used for CHO cells?

CHO cells should be cultured in Ham’s F12K (ATCC suggestion) or DMEM modified with 10% FBS. If cells are not doubling every 14-17 hours, supplement the medium with 1-2% FCS. Subculture Protocol for CHO: CHO cells grow quickly and easily and cell count should have a doubled within 14-17 hours.

What are the two cell types used in making monoclonal antibodies?

The traditional monoclonal antibody (mAb) production process usually starts with generation of mAb-producing cells (i.e. hybridomas) by fusing myeloma cells with desired antibody-producing splenocytes (e.g. B cells). These B cells are typically sourced from animals, usually mice.

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