What is Biologics Development?

What do you mean by the term biologics in pharma?

The class of medicines that are grown through large complex molecules, and purified through multiple steps are called biological therapeutics. Biological drug manufacturing involves genetically engineering cells from yeast, plants, or animals that can target specific molecular processes with high precision.

What is the process of developing biological drugs?

The process begins with manipulating or genetically engineering a single cell to get the desired protein, purifying it through purification techniques like chromatography and evaluate the purified protein for its quality and purity.

How much time does it typically takes to develop or manufacture a biologic?

The average estimated time is anywhere from 12 to15 years for manufacturing a biological therapeutic. Through the traditional approach, it might take 45-50 days to convert raw materials into the final product. However, with Bioprocessing 4.0 (also called continuous processing), the pharmaceutical manufacturing process (batch process) timeline can be drastically reduced.

What are the various stages of development in biologics?

The process starts with the discovery or identification (genes or proteins). Thousands of large molecules are scanned to search for compounds that have the potential to treat a disease. Then the second step is preclinical phase where in vitro and in vivo studies are performed, and various safety tests are carried out for safety and regulatory purposes. Once, preclinical testing are successful, the drug enters the different sequential phases of clinical trials followed by manufacturing.

Biologic v/s small molecule drug — what is the difference?

Biologics are large molecules that are produced from biological sources or biological processes, whereas small molecules are chemical compounds produced by chemical synthesis or extracted from natural sources.

What are the challenges in developing biologics?

Biologics are large molecules that are complex and hence require robust and consistent processes to ensure product quality. They are environmentally sensitive, a simple change may affect their safety and effectiveness, so a thorough characterization process is needed. Biologics drug discovery processes are very heavily regulated and so its manufacturing requires extensive documentation and deeper knowledge of regulatory requirements.

What are the examples of biologic therapies used in medicine?

• Monoclonal antibodies
• Interferon
• Interleukin-2 (IL-2)
• Colony-stimulating factors (CSF, GM-CSF, G-CSF)

Which biological therapies are used in cancer treatment?

• Monoclonal antibodies
• Cytokine therapy
• Vaccine therapy
• Antibody drug conjugates (ADCs)
• CAR T-cell therapy

How do biologic therapeutics work in treating autoimmune diseases?

Biologic drugs are specifically designed to target malfunctioning immune system components (cytokines, B-cells, and T-cells) and disrupt the inflammatory responses produced by them. Because of its targeted approach, they allow effective treatment with minimal side-effects, slowing down the progression of autoimmune diseases.

What are the advantages of using biologic therapy over traditional treatments?

• Target specificity
• Minimal side-effects
• Personalized treatment
• High potency
• Long-term therapeutic effects