Biopharmaceuticals have shown revolutionary advancements in supporting the increase in life expectancy of people. The word itself is a combination of “biotechnology” and “pharmaceutical”. We look at how these, once different fields, have combined to create new opportunities for the industry.
Biopharmaceuticals are medical therapeutics or drugs that have been synthesized or extracted from a biological source, such as living cells or organisms. In other words, they are medicines derived from living systems and produced using biotechnology. Also known as “biologics”, they include vaccines, whole blood, blood components, allergenics, gene therapies, tissues, recombinant therapeutic proteins, and living medicines used in cell therapy.
Biopharmaceuticals are extremely promising when it comes to treating some of the more intractable medical conditions including cancer and autoimmune diseases. These therapeutic agents are designed to treat symptoms and the underlying causes of several disorders and diseases.
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.
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:
Biopharmaceutical downstream processing refers to the recovery and purification of a drug substance from natural sources, such as animal or bacterial cells.
DKSH offers a range of products for use at every stage of the biopharmaceutical production process, from upstream to downstream formulation. Products in DKSH’s biopharma portfolio include amino acids, biological buffers, minerals and nutrients, growth factors, peptones and yeast extract, and sugars.
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Christoph Zahner is based in Zurich, Switzerland. He is currently Senior Manager, Global Business Development, Biopharmaceuticals at DKSH.