The biopharmaceutical industry is changing how disease treatment is approached and carried on. Biological molecules like recombinant proteins, monoclonal antibodies, biosimilars, etc are used in the treatment of a myriad of diseases. To produce the proteins, certain living organisms are required and it is difficult to optimize them. In simpler words, a proper cell line is required to obtain the required titers of the proteins. 

Outsourcing Cell Line Development

According to a recent survey, almost 86.9 percent of pharmaceutical companies outsource one or more major processes which have made the contract manufacturing industry reach a worth of 14 billion. 

To develop and maintain cell lines, the pharmaceutical company needs to expand its premises, install new equipment, and train new staff. This is sometimes, too much hassle, due to limited space, expensive machinery, the costs of maintaining the machinery once installed, and regulation of staff. So, a lot of pharmaceutical companies outsource their cell line development to contract manufacturing companies i-e CDMOs and CROs. 

Large biopharmaceutical companies which have the resources and means to install in-house cell line development services, consider the amount of product they need to produce and analyze the costs. If cost-effectiveness is not achieved, the big companies also prefer outsourcing the work. 

(Photo : CDC on Unsplash)

Priorities While Selecting A Cell Line Development Partner

It is important to balance the various factors of the manufacturing process, like speed, cost, technological innovation, and scale. Depending upon which parts of the process are being outsourced, relevant factors should be considered. While making a deal with a CDMO or a CRO, the following priorities should be given fair thought and analysis. 

1. Scientific Prowess:

Cell line development is a complicated process and to deliver the required amount of product on time, the cell line development company needs a very expert and efficient team with immaculate scientific knowledge. The subject matter knowledge is necessary for various steps in the process. 

2. Efficiency:

For all biopharmaceutical companies, the time of delivery is very important to keep the workflow turbulent-free. To achieve the efficient delivery of products, the scientific teams should be well-adept with workflows that are fast and error-free. It means leaving behind outdated and unnecessarily complex processes and removing steps that are not required. For example, pool generation. Removing this one step reduces the overall timeline by four to five weeks. 

3. Effective Analytical Team:

The analytical team of the manufacturing company should be expert in analyzing the characters of the proteins in various steps like the clone selection stage. A large amount of product that is deficient in a particular protein or does not have the desired action is a waste of time and resources.

 Knowing that the quality of the product is poor after the product has been completed is a big blow to cost and resources. Hence, to prevent these risks, the analytical team of cell line development should be experts in characterizing the proteins during the process and not after. The team should apply high-resolution nautical methods to test the product like liquid chromatography, mass spectrometry, and capillary electrophoresis. 

(Photo : National Cancer Institute on Unsplash)

4. Regulatory Expertise:

Biologics is a new modality in the field of science. The regulatory agencies demand very tight quality control on biologics. Any minor deviation from the regulatory guidelines can put the whole operation at risk, not to mention, doing everything all over again, which is cumbersome. 

So, the cell line development partner that you choose should be very careful in following the regulatory guide. It will save both companies from unnecessary activities. 

5. Flexibility and Control:

Dealing with living organisms in addition to fluctuating market and consumer demand adds to the difficulties for biopharmaceutical companies. Hence, biopharma should be more flexible than other pharmaceutical companies. 

Although, in-house, manufacturing provides the highest amount of control a company can hope for, not every company can afford this. So, biopharmaceutical companies should select cell line development partners that are very flexible when it comes to market dealings and consumer trends. 

Concluding Thoughts:

Biopharmaceutical optimization at every step is the key to developing life saving medicines for the diseased at a rapid rate with the best quality. Biopharmaceutical companies should be transparent about their manufacturing process, raw material sources, and the steps they take to ensure quality control. The straightforward information from the company plays a role in reducing the mystery surrounding the biologics and eases the doubts of patients.