Contract Manufacturing ERP: Top Development ERP Software for Life Sciences

A CDMO is a contract development and manufacturing organization, meaning they not only handle the manufacturing needs of their clients but are also part of the innovation and development process that leads to manufacturing high-quality inventory. A contract manufacturing business can manage the business from the development and raw material stage to the shop floor and distribution. These contract manufacturers can include development, production and analysis, and material sourcing, allowing their customers to limit the need to build and staff dedicated innovation and inventory manufacturing facilities.

Services often offered by CDMO companies include formulation, analytical services, blending, coating, converting, packaging, serialization, and inventory shipment. Many CDMOs based on their business focus, can start with a ready-to-go formula, or at the concept level, provide pre-formulation and formulation development services at volumes that will support both clinical trials and commercial production management.

When life science companies find the right CDMO, they gain flexibility, collaboration, and innovation services to lower process manufacturing costs and increase speed to market for new inventory. The right CDMO provides expertise and equipment at a lower overall investment that the customer does not have access to in-house. As cell and gene, pharmaceutical, and biotech components and materials become more complex and the need for innovation and production accelerates, CDMOs can provide a scalable solution delivering development and improving life science companies’ bottom lines.

Both the CMO and CDMO should be operating under current good manufacturing practices (cGMP), which is necessary for compliance with regulatory guidelines.

Contract research organizations (CRO) are hired by pharmaceutical, biotechnology, and medical device manufacturers to control clinical trials after the drug is developed internally or by the CDMO and is ready for project testing. CROs plan, coordinate, execute and supervise all processes involved in developing and running a clinical trial, including selecting a site (when applicable), recruiting participants, monitoring the trial, managing data, and more. A CRO manages feedback and requirements from multiple constituents, including manufacturers, trial sponsors, ethical committees, foundations, researchers, legal departments, trial participants and regulatory agencies. Some CDMOs are extending their service lines to offer these types of research services for your business.

A CMO is a contract manufacturing organization. CMOs are contracted by pharmaceutical, nutraceutical, and biotechnology companies to manufacture materials. The manufacturing contractor may take many forms including solution, emulsion and nano-suspension, aseptic filling, pre-filled syringe or vials, and tablets or capsules.

Pharmaceutical companies are continuing the trend towards working with a CMO partner for the production of their materials because equipment and facilities for mass production of some chemicals and for smaller batches can be very cost-prohibitive. It makes more financial sense to outsource to contract manufacturers than take on the risk and burden to invest in equipment costs for a manufacturing floor. These financial risks can be especially costly in a scenario where a product fails in clinical trials and development and production are canceled.