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How are Monoclonal Antibodies Made

During the coronavirus pandemic, the term “monoclonal antibodies” was frequently in the news. Despite this, many people still do not understand the importance of these proteins – or even what they are.

Here’s what you need to know about how monoclonal antibodies are made and how they can positively impact health and healing:

What are Monoclonal Antibodies?

The human body naturally produces proteins called antibodies that selectively identify antigens. An antigen is any substance that induces an immune response, including external sources such as pathogens, chemicals, and allergens, and internal sources such as cancer cells and even healthy cells in the case of autoimmune disease.

Sometimes, the body does not produce the correct antibodies or does not produce enough of them to be effective. In other circumstances, exposure to dangerous pathogens is too risky to allow the body to take the time to produce these antibodies naturally. In these cases, synthesized antibodies produced in a laboratory can be used to combat these harmful substances.

One of the most important types of these synthesized antibodies is the monoclonal antibody, which can be created to address a specific epitope of an antigen, increasing binding site specificity, and reducing cross-reactivity with other proteins.

How are Monoclonal Antibodies Made?

The first step in creating monoclonal antibodies is creating the immune response that would be seen in a healthy human body. Once this is done, lymphocytes are harvested, typically from the spleen or the lymph nodes.

Next, lymphocytes will be reproduced or cloned. These cloned cells will be introduced to other cells which can fortify them and make it easier for them to be reintroduced into the human body as a vaccine or other course of treatment. This may be done through chemical means with polyethylene glycol or using electric pulses which can temporarily weaken cell walls and allow for better fusion of two adjacent cells.

After all of this, the best cells are isolated and selected for reproduction. These cells are then used to create the vaccines, infusions, and other medical interventions that make monoclonal antibodies so effective and important.

How are Monoclonal Antibodies Used?

While the most familiar use for monoclonal antibodies in recent memory is in fighting the COVID-19 virus, there are actually many ways these antibodies are used in medicine.

Just a few of the applications of monoclonal antibodies include:

  • Cancer treatment
  • Transplant rejection treatment
  • Treatment of skin conditions like psoriasis
  • Addressing cardiovascular conditions, and more

Additional conditions such as rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis can also be addressed using these antibodies. In these conditions, the body produces antibodies in response to cells that are not actually hazardous, which can cause serious health concerns. Treatment with monoclonal antibodies can help to rebalance the body’s immune response and lessen symptoms in patients with these chronic conditions.

Monoclonal Antibody Screening and Production

Monoclonal Antibody Screening and Production

Monoclonal antibodies (mAbs) stem from a single, unique parent cell. As a result, these antibodies only bind to a single epitope. The production of monoclonal antibodies is crucial to research and treatment efforts regarding various diseases, both infectious and non-infectious. At Cell Culture Company, we provide customized production of monoclonal antibodies. Our team has manufactured hundreds of client monoclonal antibodies over our 40 years in business. We have the know-how and capability to carry out mass-scale antibody production.

Monoclonal Antibody Screening

The discovery process connected with monoclonal antibodies refers to the screening and identification of certain antibodies that pinpoint a specific epitope (part of an antigen molecule) for the diagnosis and treatment of various ailments – a recent example being COVID-19.

Monoclonal Antibody Production

The treatment of cancer has been enhanced recently by the design and production of monoclonal antibodies. The monoclonal antibodies we produce at Cell Culture Company have been utilized as reagents for diagnostics, research, and the development of products.

The production of custom monoclonal antibodies is a technical, time-consuming, and demanding task. Customers may give our team their antibody-producing hybridoma or other cell lines. Our scientists are able to provide monoclonal antibodies customized to the specifications of the customer.

The generation of monoclonal antibodies often involves the immunization of mice, generating hybridomas, clone screening, and ramping up the production of clones. At Cell Culture Company, we offer an alternative process usingperfusion-based bioreactors to producemonoclonal antibodies that are easy-to-scale.

The process begins with inoculating a single-use hollow fiber cartridge by which a continual flow of media transports nutrients throughout the semi-permeable fibers. For the purposes of antibody production, the bioreactor environment referred to here is monitored and sustained at ideal conditions. The bioreactor is responsible for a concentrated and continual stream of harvested product over a period of several weeks to months.

At Cell Culture Company, we offer an array of services, including downstream processing and purification of monoclonal antibodies. To learn about our specialized process for the production of antibodies, give us a call today at 763.786.0302 or reach us through our contact form.

An Introduction to Mammalian Cell Culture

An Introduction to Mammalian Cell Culture

Mammalian cell culture is a highly regarded technique with academic and research applications. It is a requisite skill for researchers whose work requires consistent, scaleable quantities of human and animal cells for pharmaceutical, immunology, toxicological, and molecular biology research. If you are interested in learning about mammalian cell culture and its vast range of applications, here’s a brief look into its study.

What is mammalian cell culture?

This refers to the process of growing cells taken from mammals in-vitro. That is, growing cells outside the original tissue in a growth medium with the right nutrients. Mammalian cells are eukaryotic, meaning the individual cells are more complex than bacterial cells, which are often used to teach simple cell culturing techniques.

This complexity also stems from the specialization of the different cells in the various organs and tissues. Mammalian cells are grouped into cell types depending on their origin, function and morphology.

Morphology of a cell determines how it is grown in cell culture. Most cells can be grouped by one of two growth conditions – adherent or suspension.

  • Adherent cells are grown on a flat surface where they adhere and grow to occupy the surface they are seeded upon.
  • Suspension cells are free-floating in solution and occupy the entire three-dimensional volume of the culture vessel.

Matching a cell’s growth condition to a culture vessel is critical to proper and effective mammalian cell culture.

Uses for mammalian cell culture

Understanding cell biology is the key driving factor of all biotechnical advancements, especially in research and medicine. Damage can occur to any of the body cells as a result of disease and injury. A deep understanding of cell biology and cell types allows researchers and scientists to develop appropriate treatment methods.

Additionally, research into mammalian cell structure can be utilized in the following ways.

  • Production of biological products such as antibodies, enzymes, hormones, etc.Recombinant antibody expression combines cutting edge molecular biology techniques with mammalian cell culture to create antibody products superior in purity and scalability to those produced using traditional methods. Using cell culture for the controlled production of biological molecules has opened up new opportunities for research and medicine that were once much less accessible.
  • Manufacture of vaccines to protect people from viral and bacterial diseases.One of the most important research models in any biological field and medicine is the in-vitro study of mammalian cells. Mammalian cell culture has been used for the development and manufacture of vaccines, which has a massive positive impact on public health. Even though it requires specialized tools and rigorous antiseptic measures to ensure no cross-contamination occurs, the proven benefits and potential promise of their application are boundless.

Understanding Cell Culture Media

Understanding Cell Culture Media

Scientists who perform laboratory research in the life sciences need to produce conditions in the lab that cater to the survival and/or growth of living cells. This is where cell culture media comes in.

At Cell Culture Company, we implement a well-tested, proven system that facilitates the acceptance of cell lines into our manufacturing center for multiplication and growth. Our system keeps the identity of your cell line protected and utilizes mycoplasma screening to confirm your cells are safe to work with in our facility and production process.

What is Cell Culture Media?

Another name for cell culture media is growth media. This term refers to any liquid or gel developed to help facilitate the growth of cells in an artificial setting. This artificial environment is essential for cells, tissues, and organs scientists remove from living creatures, if they are to remain viable. Cell culture technology relies on culture medium in the support of in vitro cellular research. This medium is the source of nutrients cell cultures need to survive and multiply. It also provides proper pH and osmolality, which is the concentration of dissolved particles of minerals and chemicals.

When selecting a proper growth medium, scientists must factor in the type of cells involved. The types of cell culture media chosen must be based on a variety of factors, including whether the cells are from mammals, insects, plants, viruses, bacteria, or yeast. Results of experiments depend on the correct choice of cell culture medium.

Elements of Cell Culture Media

Cell culture media consist of a mixture of nutrients and compounds designed to help promote the growth of cells. Common components of cell culture media include amino acids, carbohydrates, vitamins, basic and trace elements, inorganic salts, hormones, serum, buffering systems, and antibiotics.

Types of Cell Culture Media

There are two major categories of cell culture media – natural and synthetic. Natural media come from animal body fluids or tissue extraction, and may include tissue extracts, biological fluids, and clots or coagulants. Synthetic media, also referred to as artificial media, are produced using various compounds (organic and inorganic).

For information about the services we offer to our clients in the fields of genomics, diagnostics, point-of-care, research, and genetic engineering, call us today at 763.786.0302 or complete our contact form.

Protecting the Supply Chain: What Immunodiagnostic Companies Need to Know

Diagnostic companies invest substantially in developing new products. Many think their biggest challenge will be developing the perfect test, but optimizing their new product supply chain to be secure and efficient is nearly as important and difficult as creating their product. The best diagnostic will fail in the market if the company can’t meet production timelines and costs.

During and post-development, immunodiagnostic companies find themselves in a few specific binds:

  • In-house manufacturing can’t keep up with product portfolio expansion.
  • Antibody manufacturing can be inherently unpredictable.
  • It is challenging to assess the reliability of a potential outsourcing supplier against price point.

In this article, we’ll take a look at how these issues impact product launch and revenue, and present some suggestions for overcoming these roadblocks.

In-house manufacturing: how much trouble is it worth?

Speed to market can heavily influence a new product’s success. Even when there are no pressing competitors, any delay lengthens the runway to seeing a return on investment (ROI). In-house manufacturing can decrease the cost of manufacturing each product (after the initial capital expenditure) and could help get products out the door faster and on a company’s own schedule.

In-house manufacturing comes with significant challenges.

As a company’s product portfolio grows, their own manufacturing facility begins to lose its supply chain advantages. Companies with in-house facilities designed around roller bottles, ascites, or a single product at a time eventually reach their capacity. Products are delayed not due to issues in development or design, but because in-house facilities are already booked out with current products.

Changes in production strategy between products or in the manufacturing process also affects how much and how quickly each batch of antibody can be made. In an overburdened production facility, flexibility is a commodity.

Organizations with insufficient in-house production face two choices:

  1. Build out their internal capacity to meet their growing portfolio needs
  2. Outsource to a contract manufacturing organization (CMO)

Impact of Investment

As the product pipeline grows, companies reliant on in-house manufacturing may consider building out additional capacity. To make this decision, they must carefully weigh the benefits of additional manufacturing space against the risk of the investment.

While “adding more capacity” sounds like an easy fix, new facilities cost millions of dollars to construct and maintain. In a volatile industry, this is an enormous risk. Product demand is difficult to forecast, and redundant capacity can be an expensive mistake.

Redundant in-house capacity can be an expensive mistake.

Building out a new facility – especially a GMP facility – can take years.  For that reason, companies need to invest well before they have a product to launch. Therefore, they need to be certain that a build-out will have the appropriate ROI before deciding it is the right option for them.

Turning to a CMO

The alternative option is to employ a contract manufacturing organization (CMO). These entities offer services to simplify the production process to save diagnostic companies time and money.

CMOs provide flexibility via their own manufacturing facilities. A good CMO will have the ability to scale-up or -down according to the product’s market demand without putting strain on prices or timelines.

This is especially true for CMOs with modular, closed-loop biomanufacturing systems such as hollow fiber bioreactors. This in vitro method of production takes up very little space and can be wheeled in and out of facilities as needed. This added level of adaptability allows CMOs to reduce overhead costs and pass those saving on to the customer.

A CMO also brings expertise and quality, both of which are difficult and expensive to obtain and manage. For companies with fledgling products, bringing in a CMO who can optimize a production process to decrease manufacturing cost of goods is a worthwhile investment.

Cell Culture Company as your manufacturing partner

Cell Culture Company’s mAbVault program may be the supply chain answer your company is looking for. Over the past thirty years, we have produced low cost, high quality biologics for some of the largest diagnostic companies in the world. Our supply chain solutions offer:

  • Guaranteed price per mg of product
  • Guaranteed quantities and long-term storage
  • Lower investment, cost, and flexible pricing options
  • Pay only when we ship product to you

For more information on mAbVault or to discuss supply chain options with us, please visit our website at https://cellculturecompany.com/supply-chain.

Post by Samantha Dunmire, PhD and Emily Wozniak, PhD