How Biopharma Is Changing the Pharmaceutical Landscape

The main difference between pharmaceuticals and biopharmaceuticals is the method by which the drugs are produced. Pharmaceutical products are manufactured using chemical-based processes. Most companies in this industry produce medications for human illnesses. 

Biopharmaceuticals, on the other hand, are made from living organisms such as bacteria, yeast, and mammalian cells. By doing this, the industry hopes to either change the function of a living cell or duplicate it so that it behaves in a more controllable and predictable way.

When compared to chemical drugs, biopharmaceuticals are more complex in production, can be administered in various ways, and have different pharmacokinetics. Pharmacokinetics is a term used to describe the movement of a drug into, through, and out of the body and is, in fact, the study of the duration of absorption, distribution, metabolism, and excretion of the drug.

Biopharmaceuticals are known to have various clinical applications and advantages for disease therapy, prevention, and diagnosis.

• Therapy – Therapeutic types of biopharmaceuticals include recombinant protein therapy, antibody therapy, cell therapy, and gene therapy. Biopharmaceuticals aim to cure and/or treat diseases safely and effectively by demonstrating biological activity and performing specific functions by acting on the disease pathophysiology
• Prevention – A vaccine is the most important biopharmaceutical used for infectious disease prevention. It usually contains a biological agent that resembles a pathogen and is generally made from inactivated microbes, live attenuated microbes, toxoids, and part of surface antigens
• Diagnosis – Along with therapy and prevention, some biopharmaceuticals can be used to diagnose diseases as well. They are also very useful in immunohistochemistry that detects antigens in fixed tissue sections and immunofluorescence tests that detect the substance in frozen tissue sections or live cells

Their high efficacy and fewer side effects result in an exceedingly well-done job, which in turn, ensures that treatments evolve at a rapid pace and continued research constantly introduces new types of products.

The market has seen the introduction of new concepts such as the cell therapy Provenge, which is used to treat cancer and gene therapies, offering promises of regenerative medicine or disease remission.

According to mckinsey.com, biopharmaceuticals generate global revenues of USD 163 billion, making up about 20 percent of the global pharma market. The efficacy and safety of biopharmaceutical products, combined with their ability to address previously untreatable conditions, allow pharma companies to command high prices for innovative drugs.

A study published in the National Center for Biotechnology Information titled Metaheuristic Approaches In Biopharmaceutical Process Development Data Analysis states that the implementation of advanced process control strategies based on multivariate monitoring techniques in biopharmaceutical production has given rise to the generation of large amounts of data. It added that data mining can facilitate the extraction of meaningful relationships about these bioprocesses and predict the performance of future cultures.

Since it is impossible to manufacture identical copies of biological products even after following well-defined analytical characterization and manufacturing techniques, continuous real-time quality control and assurance in biopharmaceutical manufacturing is the need of the hour. The significance of enforcing Process Analytical Technology measures in the manufacturing process is high. With this, the data can then be used for forecasting, identification of trends, relationships, patterns, and anomaly detection.

Upstream products are engineered to enable advanced production scale-up with maximum efficiency and quality. The production of active pharmaceutical ingredients (APIs) of biopharmaceuticals typically starts with the generation of the API via living cells known as the upstream process:

• Upstream Processing – Upstream processes are those in which biological materials are either obtained from an outside source or inoculated and grown in culture, under controlled conditions, to manufacture certain types of products. The initial steps of the upstream process start with milliliter quantities of mammalian or microbial cells engineered to produce a specific protein molecule. Recent upstream processing innovations include enhanced sensor technology, single-use bioreactors, and automated cell culture systems
• Upstream Biomanufacturing Technicians – Upstream biomanufacturing technicians work with living cells or other forms of biological materials. They grow cells in specialized environments and ensure that cells with transfected genes have the factors they need to grow and produce the desired proteins

Biopharmaceutical downstream processing refers to the recovery and purification of a drug substance from natural sources, such as animal or bacterial cells.

• Downstream Processing – Downstream processes are those in which the products are harvested, tested, purified, and packaged. Maximizing purification throughout the filtration steps and ensuring protein stability, solubility, and bioavailability of the finished biologic are the core goals of the downstream process. The key purpose is to isolate, purify, and concentrate the previously synthesized drug substance/product from the complex bulk matrix
• Downstream Biomanufacturing Technicians – Downstream manufacturing technicians harvest and purify recombinant proteins or other products obtained from the upstream cell expression systems. The technicians' goals are to produce a pure product, with a high yield, in an efficient manner