Toll Manufacturing
Pharmaceutical contract manufacturing is a speciality within the more general umbrella term of contract manufacturing and is the process by which drug companies outsource their manufacturing needs on a contract basis to equipped companies. These contract manufacturing organizations (CMOs) spend their time developing, formulating, and testing products, allowing the drug company to focus on marketing, discovery, and scalability. Contract manufacturers can also provide raw materials, machines, and fabricating services needed for drug production.
Pharmaceutical contract manufacturers serve many purposes. They help relieve the burden of production off drug companies by providing services such as:
- Drug development
- Manufacturing and commercial production
- Process equipment fabrication/set up
- Documenting FDA regulations and obtaining compliance
- Pre-formulation
- Stability studies/method studies
- Pre-clinical to late-stage clinical trial material
- Scale-up, registration batches
Why outsource pharmaceutical manufacturing?
Pharmaceutical manufacturing is time-consuming, difficult, and laden with regulations. It makes sense for a drug company to outsource this production to third parties, as it not only reduces internal costs but also allows the company to focus on more important items. Drug companies using a CMO have an increased ability to:
- Fast track time to market
- Improve drug discovery and marketing
- Reduce labour and training costs
- Keep up with growth trends
- Limit financial risk in case of late-stage product failure
