Biotechnology and Pharmaceutical Manufacturing Services

Biotechnology and pharmaceutical manufacturing services active pharmaceutical ingredients, sterilize biomedical components or materials, validate processes or packaging, and formulate drug or medicinal preparations on a contract basis. They produce drugs, biochemicals, active pharmaceutical ingredients (API), biomaterials, vitamins, biomedical components on a contract, toll, customized, or research and development basis. The pharmaceutical ingredients that biotechnology and pharmaceutical manufacturing services process can consist of organic or inorganic chemicals, as well as biological or natural materials.

Biotechnology and pharmaceutical manufacturing services may provide additional extraction and purification steps to retrieve the biochemical from the biomass or by-products after synthesis is complete. Drying, evaporation, filtration, distillation, milling and other purification processing steps are utilized to extract and purify biotech and pharmaceutical ingredients. Active drug ingredients for injectable drug delivery can be blended or mixed with saline or other liquid solution to the correct concentration. Microencapsulation is a process that biotechnology and pharmaceutical services use to create time-release drugs.  

Selecting biotechnology and pharmaceutical manufacturing services requires an understanding of various processes. Biotech and pharmaceutical synthesis involves the conversion of raw materials into different or more usable molecules or chemical compounds. Bioactive ingredients can manufactured through a synthetic process or through natural biotransformations using bacteria, yeast, mold, or other microbes (biomass) in a bioreactors or fermenters.  Fermentation is an example of a biological reaction where sugars are converted to alcohols. Vitamins, enzymes, penicillin and other antibiotics also utilize a fermentation step during the biochemical production process.  

Biotechnology and pharmaceutical manufacturing services use other chemical reactions to synthesize drugs or pharmaceutical ingredients. For example, hydrogenation is used to produce sugar alcohols such as sorbitol or xylitol from glucose or sugar feedstock. Oxidation, esterification, acylation, hydroformylation, are additional chemical reactions utilized in chemical and biochemical manufacturing. A biochemical reaction’s rate can be controlled with a catalyst. Catalysis is the process of slowing or speeding up biotech and pharmaceutical reactions by adding a substance that is not changed in the reaction process. In some chemical reactions, biotechnology and pharmaceutical manufacturing services require large amounts of heat and energy.

Biotechnology and pharmaceutical manufacturing services provide intermediates, reference compounds, starting materials, or derivatives of compounds. Scientists, engineers and other technical personnel who work for biotech and pharmaceutical manufacturing and synthesis services are trained in disciplines such as pharmaceutical science, pharmacology, biomedical engineering, biology, microbiology, synthetic organic chemistry, analytical chemistry, or biopolymer chemistry. Some biotechnology and pharmaceutical manufacturing services work on a toll or fee basis. These toll processors may hire operators to run the process equipment, or rent or lease their facility to a client who can bring in trained personnel. Employees can also perform processes such as distillation, drying, mixing, blending, purification, extraction, or synthesis.

Biotechnology and pharmaceutical manufacturing services may also specialize in the production or biomaterials or biotech and medical devices on a contract basis. Biomaterials are biocompatible materials.  Medical devices can include products for delivery of drugs (syringes, intravenous devices), components in medical equipment contacting blood or other biofluids, and implant or prosthetic devices.   Sterilization and validation of sterilization of ingredients, drugs, packaging or medical device is another critical step in biotech and pharmaceutical manufacturing.

Providers of biotechnology and pharmaceutical manufacturing services adhere to regulatory requirements and meet various quality standards. In the United States, relevant regulatory agencies include the United States Pharmacopeia (USP), the Food and Drug Administration (FDA), the Environmental Protection Organization (EPA), and the Occupational Safety and Health Administration (OSHA). Biotechnology and pharmaceutical manufacturing services pay particular concern to FDA’s cGMP or current Good Manufacturing Practice standards (cGMP).

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