Development of Upstream and Downstream Processing in Biopharmaceutical Manufacturing

The biopharma industry depends on change to grow in an environment that instantaneously demands higher quality, lower costs, and higher productivity. In upstream process development, biological materials are either acquired from outside or injected and bred in culture, under regulated conditions, to produce products. On the other hand, in downstream process development, the products are collected, purified, tested, and packaged.

Different forms of biopharmaceutical process development involve technicians to wisely control the environment in which the cells grow.  If the product is to be used as a drug, biomanufacturing experts must work in places where current Good Manufacturing Practices (cGMP) are followed strictly.

The progress witnessed in the industry has been remarkable, but the refined exterior of bioprocessing hides an interior of despair that cries under the burden of current demands. The rise in production achieved previously have been a result of enhancements in the upstream production phase, mainly due to efficient bioreactors and better media formulations.

Millions of clinical studies are taking place right now, but only a small number of drugs get approved. The number of drugs under trial that eventually make it to drug stores is quite small. The limited success has increased the pressure on companies to store many products, thereby boosting demands on process development groups to reduce time-to-clinic and time-to-market. Furthermore, the proteins which have been recently approved will need lifetime doses 10-100 times bigger than recombinant drugs. 

Molecule Challenges

 A major challenge facing the biopharma industry today is the supply of molecules. This is critical and important to save lives and to the wider population in general. This is vital to make a large amount of protein and to scale it up. There is another issue of the overall diversity of the molecules and finally the issue of minimizing the research and manufacturing cost.

One simple way to enhance process scale purification is to lower the number of steps in the process. When you go down from four steps to two, the transition to an uninterrupted process becomes easier. However, if you have three or four steps, it is not easy to move to an uninterrupted process. With resin chemistry, there is an opportunity to cut those steps and make things simpler.

Drug development is not entirely transparent. However, here we will explain the process that most drugs go through before it reaches the cabinet. 

1. Drug discovery and target validation:

In the first step a molecule must be chosen, such as a protein or gene to aim with a drug. After analyzing several molecules, the drug firm will choose the one that shows maximum promise.

2.Preclinical testing: 

There are two parts in the next step of the development process: in vitro and in vivo testing. In this phase, scientists will cut thousands of molecule candidates to just a few.

3.Investigational new drug application filing:

In this step, the firm must submit a new drug application to the relevant authority before starting human trials. The relevant authority will examine the results from preclinical testing.

4.Clinical studies: Clinical studies are carried out in three phases. 

• Firstly, a few people are administered the drugs and an observation is made depending on how the drug is absorbed and eliminated from the body and any resulting side effects and whether it is leading to the desired effect.
• Secondly, the patient pool is broadened to 100 people or more and it includes people who are suffering from the illness in question.
• Finally, thousands of patients are included and is by far the priciest in the development process. In this phase, safety remains a priority, but effectiveness also plays a significant role.

5.Drug application filing: 

Here, the drug company files a fresh application with the respective drug authority. Here the authority promises to take another look at the application over the next few months.

6.Remedial measures:

Eventually, the drug authority will ask the company to run more studies or change the manufacturing process. Once approved, the drug is sent to the market immediately.

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