In order to clearly understand active pharmaceuticals contract manufacturing an understanding of terminology is of prime importance. The first term to understand is what is meant by "active ingredient". An active ingredient has been defined as any component or substance that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to effect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change and be present in a modified form intended to furnish the specified activity or effect. In other words, the active ingredient is the component responsible for the desired effect and has also been called "bulk active" or "bulk drug substance."
An active ingredient is formulated with other components that don't perform the intended chemistry or biochemistry in the body. These latter components are called "inactive ingredients." Active and inactive ingredients are mixed together in various dosage forms (such as tablet, capsules or liquids) to yield a "drug product." So within this drug or pharmaceutical product given to a patient, the active pharmaceutical ingredient (API) represents the ingredient that is intended to furnish pharmacological activity in a finished drug product.
APIs include substances manufactured by processes such as (1) chemical synthesis; (2) fermentation; (3) recombinant DNA or other biotechnology methods; (4) isolation/recovery from natural sources; or (5) any combination of these processes. Within the pharmaceutical industry, the entire process of making a drug product may be conducted by the owner of the drug, or, alternatively, it is not unusual that the owner may engage an outside party or parties to complete the entire manufacturing process, or one or more discrete operations, under contract. These outside parties are called Contract Manufacturing Organisations (CMOs). One possible strategy for a drug owner is to contract with a CMO to manufacture APIs.
In general, although some companies are hesitant to outsource because of data security, perceived performance, or concerns around change management, most drug companies have realized the return on investment has been worthwhile and that with the right partner, the advantages outweigh the potential risks. Also, through outsourcing, companies may not only be able to decrease overhead costs over time, but also gain access to a flexible workforce comprised of highly-specialized experts. Recently, increased outsourcing to CMOs has been observed for drug owners running the gamut from biopharma to pharma companies, from small to large firms, and for early to late-stage development projects.
PharmSynth wants to be your trusted partner in the production of APIs. We have the capacity to manufacturer most types of APIs. PharmaSynth has a TGA (Australian equivalent of the FDA) licence for the manufacture of human therapeutic APIs from both biological and synthetic sources. We are cost competitive, and have the resources and expertise to handle all stages of API manufacturing from pre-clinical, through phases 1, 2 & 3 of clinical development, and into the marketplace.
PharmaSynth is a Brisbane, Australia based, drug development and contract manufacturing organization (CMO) serving the pharmaceutical, biotechnology and veterinary industries. For more information visit: www.pharmasynth.com.au or email us at: enquiries@pharmasynth.com.au
Orignal From: API Contract Manufacturing
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