Publications
Chimica Oggi-Chemistry Today
Agro FOOD Industry Hi Tech
H&PCToday
     
 
     
p. 10-13 / APIs
Conflicts and opportunities in the Life of APIs
GIRISH MALHOTRAEPCOT
International, 29150 Bryce Road, Pepper Pike, OH 44124, USA

KEYWORDS: Active pharmaceutical ingredients (API); Brand drugs; Generic drugs; FDA; Process development; Pharma business model; Process simplification; Sustainability; Quality by Design (QbD); Quality by Analysis (QbA); Process Analytical Technologies (PAT)
ABSTRACT: Consumers would like to have drugs that are of consistent quality and at the lowest price. However, with Pharma's current business model considerable effort is needed to maintain product quality and there are conflicts. Focus of the current pharma business model is invent a new molecule, commercialize and abandon i.e. let the generics take over when the patent expires. Due to less than efficient manufacturing technologies considerable effort is needed to maintain quality and comply with regulatory requirements. Even with this effort companies come short as evident by recent recalls and consent decrees.
Making a grass root change in process development and manufacturing practices can easily eliminate these conflicts. One has to understand and exploit physical and chemical behavior of chemicals (sociochemicology) of the chemicals involved and produced in the manufacture of active ingredients. Creative application of unit processes and operations is equally important. Such processes not will produce quality product but will have lower manufacturing cost (higher profit), will be safe and sustainable.

Consumers would like to have drugs that are of consistent quality and at the lowest price. However, with Pharma's current business model considerable effort is needed to maintain product quality. It is a continuous challenge as seen from numerous recalls and citations. Drugs are priced at the highest-level customer can afford. Rationale is our sentiment that we want to extend our life at any cost. Competitive pricing is generally not a consideration. This is very unlike any other competitive business. Many governments are making every effort to control drug prices. It is a battle.

During and after patent life of every API and its formulation conflicts come in the way of the lack of best manufacturing technologies and lowest costs. A review of the business models might explain why the conflicts exist. Focus of this article is to discuss how we can have the best technologies that deliver highest quality API (small molecule) and their formulations at the lowest cost. Methods that can improve the manufacturing technologies are also briefly reviewed.

CURRENT BUSINESS MODEL AND MANUFACTURING PRACTICES

Brand/ethical pharma
The current pharma business model is invent a new molecule, commercialize and abandon i.e. let the generics take over when the patent expires. Companies make every effort to be the first on the market with the invented product. Products are commercialized after necessary clinical trials and regulatory approval. Since the market size (due to drug efficacy, coverage and pricing) is mostly not known, universal methodology followed by the companies is to develop, scale-up and commercialize the product in the equipment that is generally available at the inventor company or their contract manufacturers. In such processes reaction progression is validated by repeated in-process analysis of samples (i.e. Quality by Analysis, QbA). Process parameters are adjusted as necessary. These practices extend the API cycle time for every process step...In order to continue reading this article please register to our website – registration is for free and no fees will be applied afterwards to download contents.

OurLatestIssues
Chemistry
Food
hpc
KeepInTouch
Teknoscienza Mobile
Teknoscienze - Viale Brianza 22, Milano - ITALY - P.IVA 06817720151
Teknoscienze S.r.l. © 2012 - tutti i diritti riservati - web terms & conditions - privacy - Credits