Big molecules, huge potential

Biopharmaceuticals now and in the future

Biopharmaceutical drugs are a great source of hope for many patients, offering a range of new therapeutic apporaches targeting previously untreatable diseases precisely.

Hopes for the future

Biopharmaceuticals have already made a difference for serious conditions such as autoimmune or rheumatic diseases, multiple sclerosis, and cancer; the possible future applications are many. Researchers in oncology hope for breakthroughs including the targeted activation of the body's own immune system against tumors, and the use of genetically modified cells or oncolytic viruses. Biopharmaceuticals also offer options for previously untreated, or poorly-treated, rare diseases – rare skin conditions, for instance.

Monoclonal antibodies – which can be very precisely targeted - make up the majority of approved biopharmaceuticals, but other types include genetically modified proteins as well as vaccines, peptides, and gene and cell therapies.

In 2022, almost every second new approval in Europe was for a biopharmaceutical (4 percent); in the USA it was over 40 percent. In Germany alone, the decade to 2021 saw the number of approved biopharmaceutical products rise by over 180%, from 197 to 362. According to the current Biotech report of the German Association of Research-Based Pharmaceutical Companies, the share of biopharmaceutical pipeline projects there continues to grow, too.

The biopharmaceutical difference

What makes this type of active ingredient special is their size - they are tiny giants. Chemical agents, like acetylsalicylic acid have a mass of around 0.18 kilodaltons; biopharmaceutical molecules quickly reach 10,000 to 100,000 times that size. And while chemical drugs have a comparatively simple structure and can be replicated by standardized processes, biopharmaceuticals are complex proteins or peptides, produced in living organisms using complex biotechnological processes. The tools are already in the cells (e.g., yeasts or bacteria), but they need instructions to produce the desired active ingredient – so the cells are genetically modified to release the desired molecules to produce the drug.

The biopharmaceutical production process

Those cells are very sensitive. Even small changes in their environment, for example due to fluctuations in physical parameters such as temperature, pH, or pressure, can have a major impact on production. This makes the development of a stable production process a particularly critical step; it determines the final product quality, so continuous process control is essential. In fact, every aspect of work on these active substances, from research to production, is highly complex, demanding highly specialized expertise, technologies, and equipment.

Boehringer Ingelheim and biotechnology business: a history of expertise

Boehringer Ingelheim is a pioneer in biopharmaceutical research, active in the field since 1963. In recent years, we have earned four marketing authorizations based on our own research and development; our Boehringer Ingelheim BioXcellence™ business has also earned worldwide success and recognition as a leading contract manufacturer for biopharmaceuticals.