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Large Molecule

Solutions Large Molecule

Biologics are medications targeting specific genotypes or protein receptors. In contrast to most chemically synthesized drugs with clearly defined structure, most biologics, due to their large and complex molecules, are not easily identified or characterized. It is also because of their size that biologics are usually administered via injection or infusion rather than oral administration. They are obtained through isolation from a variety of natural sources (e.g., human, animal, or microorganism), and can also be produced by biotechnological methods and other cutting-edge technologies.

Biological products are diverse and wide-ranging, which may include vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. According to the Food and Drug Administration (FDA), although complex and tedious to work on, biologics in time, may offer the most effective means to treat various medical illnesses and conditions for which no other treatments are available.

Additionally, since these products tend to be heat sensitive, and susceptible to microbial contamination, aseptic technique must be observed in all stages of drug manufacture. Biologics are also being regulated by the Food and Drug Administration (FDA), specifically by the Center for Biologics Evaluation and Research (CBER). CBER is one of the centers within FDA, and is an agency within the United States Government’s Department of Health and Human Services (HHS), that aims to protect and advance the public health by ensuring that the biological products are safe, effective, and available to those who are in need.

Esco Pharma provides specialist services, equipment packages, and process solutions from our core platform products. Together with its wide range of innovative and turnkey solutions, backed with four (4) core technologies, Esco Pharma enables various industries such as pharmaceuticals, nutraceuticals, and cosmeceuticals to comply with the internationally accredited GMP, as well as, industrial, environmental, and health and safety standards.


References:

  1. Morrow, T. & Felcone, L. (2004). Defining the difference: What Makes Biologics Unique. Biotechnology Healthcare, 1(4), 24-26, 28-29. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564302/
  2. U.S. Food and Drug Administration. (2019). Center for Biologics Evaluation and Research (CBER). Retrieved from: https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber
  3. U.S. Food and Drug Administration. (2018). What are "Biologics" Questions and Answers. Retrieved from: https://bit.ly/FDAWhatAreBiologics
  4. U.S. Food and Drug Administration. (n.d.). Biological Product Definitions. Retrieved from: https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf
  5. U.S. Food and Drug Administration. (n.d.). CDER World: Biologics Review. Retrieved from: https://www.accessdata.fda.gov/scripts/cderworld/index.cfm?action=newdrugs:main&unit=3&lesson=1&topic=1

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