What Is the Cell Line Development Process?

The cell line development process is essential in determining the efficiency of finding new drugs, toxicity, and in-vitro testing. This process reduces cost, effort, and time, which reduces the possibility of drug failure during clinical trials. During the cell line development process, recombinant proteins are produced. These include bi-specific and monoclonal antibodies, vaccines, fusion proteins, enzymes, growth factors, and innovative ways of developing immunotherapies for cancer treatment. At Cell Culture Company, we offer production services for various antibodies, including monoclonal and recombinant, as part of the cell line development process.

Faster Cell Line Development

In an effort to bring down the costs of cell line development, researchers have been pressured to find ways to advance through the early steps of biotherapeutic discovery and candidate selection. Efficiency in this process is achieved through the quick production and selection of cell lines that provide quality recombinant protein in high concentrations, while eliminating clone candidates that are prone to fail as soon as possible.

Cell line development technological advancements have boosted the testing of various drug candidates during the early stages of development, resulting in time and cost efficiencies. Also, companies working on cell line development projects and drug discovery have been collaborating together, resulting in the growth of the cell line development industry.

Cell Line Development Process

The process of cell line development encompasses the following steps:

Transfection

This is the process of bringing together a foreign DNA with a host cell. When the foreign DNA is incorporated into the genome of a small population of cells that enables them to express recombinant protein over an extended period of time, this group of cells are identified as stably transfected cells.

Antibodies Screening and Titer Ranking

From the transfected pool of cells, a discovery and selection of high-value clones is performed. The chance of discovering a high producer or high affinity-binder is done through screening large populations by quantifying protein-of-interest cell surface expression or secreting antibodies (titer ranking).

Single-cell Isolation and Viability of Cells

In order to ensure the cell population is identical genetically and the heterogeneity of expression is markedly reduced, it is necessary to isolate and clone single, viable cells.

Monoclonality Assurance

From the perspective of quality and regulatory adherence, it is vital to ensure the cell line is monoclonal, meaning it originates from only one progenitor during the development of cell lines for biotherapeutics. Monoclonality must be documented in the production of therapeutic cell lines as a regulatory requirement, and this is usually an image-based documentation in which recording of a single cell image is taken and added to the regulatory filings.

Clone Productivity Screening and Titer

This test determines the quantity of recombinant antibodies or proteins generated from a cell line derived through cloning.

To learn about our antibody production processes at Cell Culture Company, give us a call today at 763.786.0302 or use our contact form to leave us a message.

Why Recombinant Antibodies Are the Next Step Up in Antibody Technology

Biomedical research has made great advancements through the use of monoclonal and polyclonal antibodies in various experimental applications. However, each of these types of antibodies has its own weaknesses and limitations, which have led numerous researchers to prefer recombinant antibodies. At Cell Culture Company, our recombinant antibody production capabilities enable us to assist our customers in their advancement of medical research and development of treatments that meet the unique health needs of patients.

Shortcomings of Monoclonal and Polyclonal Antibodies

The use of monoclonal and polyclonal antibodies in experiments has revealed some inconsistent results, including issues related to reproducibility when utilizing animals. Variations between batches and non-specific antibody binding were observed. These variations in results are to be expected for polyclonal antibodies since they originate from animal serum and each new batch is produced from a different immunization or animal. However, the variations have also been noticed with monoclonal antibody production. Therefore, a new form of antibodies has been sought – and that is where recombinant antibodies come in.

Recombinant Antibodies – The Future

As a type of monoclonal antibody, recombinant antibodies are produced in-vitro using a synthetic gene without creating hybridomas or immunizing animals.

Any species of animals that produces antibodies may be used to clone recombinant antibodies. Modification of the sequence is possible after it has been cloned, which gives recombinant antibodies a distinct advantage.

There are a number of advantages recombinant antibodies have over monoclonal antibodies. These include:

• The time required to produce recombinant antibodies is much shorter, often just a few weeks compared to months for the production of effective antibodies from hybridomas.
• Their technology is reproducible. They are more reproducible and reliable than monoclonal antibodies since the sequence of the recombinant antibody gene is known and cloned.
• The production of recombinant antibodies uses animal-free technology, relieving concerns about complying with rules around the world related to animal experimentation.

The shorter turnaround time involved with the production of recombinant antibodies and the complete control over the antibody sequence makes them ideal for diagnostics, therapeutics, and research.

For information about our recombinant antibody production capabilities at Cell Culture Company, call us today at 763.786.0302 or reach us through our contact form.

Understand the Uses and Benefits of Recombinant Antibodies

Recombinant antibodies (rAbs), which are genetically engineered, are forms of monoclonal antibodies produced at the genomic level by the means of in-vitro manipulation. With these antibodies, there is appropriate use with a range of cell lines, including bacterial, mammalian, insect, and yeast origin. At Cell Culture Company, we are your source for monoclonal and recombinant antibody production to match the customized needs of our customers.

Benefits of Recombinant Antibodies

There are several characteristics to recombinant antibodies that have given them continuing favor and preference in the eyes of researchers. Some of these characteristics we describe below:

1. Unsurpassed Replicability and Consistency

In contrast to more traditional forms of antibody production, the generation of recombinant antibodies revolves around a group of unique genes which makes their production exceptionally reliable and controllable. With replicability and consistency, researchers can avoid issues such as gene mutation, gene loss, and the drift of cell lines that can sometimes occur with other antibody production, resulting in a resolving of differences between batches and dependable results.

2. Easy to Manipulate

The methods of recombinant antibody production enable extensive control and monitoring of the antigen during production, in contrast to what occurs with much of the trial and error during traditional antibody production.

3. Higher Specificity and Sensitivity

The production of recombinant antibodies allows for the generation of a very desirable quality of antibodies.

4. Easy Isotype Conversion

The production of recombinant antibodies enables modifications in sequence to accommodate specific needs after the establishment of the desired fragment.

5. Animal-Free Technology

Recombinant antibodies that stem from human or synthetic collections are not associated with animal immunity. As such, concerns over the welfare of animals in connection with techniques such as immunizations and euthanasia to produce antibodies is removed.

Recombinant Antibody Applications

Recombinant antibodies are just blossoming in their use and applications – they are new in toxicological research and biomedical science. Thus far, treatment breakthroughs connected with their use have included the treatment of viral infections, auto-immune diseases, cerebrovascular disease, cardiovascular disease, tumors, and Alzheimer’s disease.

As additional research is performed, more understanding and treatment possibilities using recombinant antibodies is expected, including the prevention of more illnesses.

To learn about the recombinant antibody production services our team offers at Cell Culture Company, give us a call today at 763.786.0302 or leave us a message using our contact form.

Large And Small Production – Right Sizing Your Custom Manufacturing

If you have unique size requirements or need a custom solution, a one-size-fits-all approach is simply not going to work. Fortunately, Cell Culture Company is here to help you with right-sizing your custom mammalian bio-manufacturing, regardless of whether you have large, small, or variable-scale production needs.

What Is Right-Sizing?

Right-sizing is a principle of processes that are ideally suited for your operations, as opposed to processes designed for large-scale production that would require a large upfront cost with a potential for wasted resources as needs change.

Right-sizing is finding a balance between excess and downsizing. Right-sizing is also an excellent way to save space because you will not need additional space for processes and equipment that you do not need in order to accomplish your production goals.

Large-Scale vs. Small-Scale Production

Large-scale productions typically have dedicated manufacturing sites and premium budgets. Small-scale productions face higher costs per unit than large-scale productions and there is typically a much longer wait for site availability. The reason for this is that small-scale productions are often considered to be lower priority than large scale and small-scale manufacturers are more rare in the market.

At Cell Culture Company, we are dedicated to providing flexible, custom solutions to support research through commercialization. From cell banking to product purification, we have more than four decades of experience in cell culture services. We are committed to providing the necessary resources to make sure that our services and products meet customer expectations. Talk to our experts today to learn more when you call 763-786-0302.

Speed Up Your Research By Outsourcing Cell Culture

The strategic outsourcing of cell culture can be a cost-effective and highly flexible way to reduce the amount of time required for your research. Cell Culture Company can help you to achieve just such an objective by providing you with our experience and service offerings. Additionally, each project we perform is custom allowing for adherence to your protocols. Allow us to provide you with services if you need expertise, capacity or do not have mammalian cell culture laboratory space.

Clearly Defined Goals

If you are thinking about outsourcing cell culture, meet with our team to discuss the goals of your project. We want to make certain that your priorities are effectively set during preliminary discussions regarding outsourcing cell culture. Our team will consider your goals and priorities in developing a project plan to meet your specific needs and budget. From start to finish we strive to achieve each of your research objectives.

Custom Cell Culture Services to Meet Your Needs

Cell culture requires accuracy and strong attention to detail, in addition to a controlled environment. For over 40 years research groups have entrusted their projects with Cell Culture Company. We use our hollow-fiber bioreactors along with traditional mammalian cell culture methods, such as spinner flasks and roller bottles. This ensures that regardless of your industry, you will get the results that you need. You can rely on us for a wide variety of cell culture services, including cell banking, cell expansion and protein production services. If you have any questions, give us a call today at 763-786-0302.