1 Outsourcing
Companies hire us to:
- Search and find new contract suppliers (CMO and CDMO)
- Assess the technologies of new suppliers in a neutral way and make a pre-selection of possible contract manufacturers
- Plan, budget and implement the entire outsourcing project
- Make the supply chain more robust, reduce costs and increase efficiency
Independent of suppliers and contract manufacturers (CMOs). Consulting and implementation.
MORE Finding the right contract manufacturer partner (CMO) has far-reaching consequences for the efficiency and profitability of a product.
The transfer of production to a contract manufacturer and the necessary adjustments in the manufacturing method are relatively complex projects with numerous departments and partners involved. Regulatory requirements often come to mind, but the technical and administrative changes are also complex.
We are independent of suppliers and contract manufacturers and can represent your points of view effectively.
You gain valuable time and are on the market faster!
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More power together Outsourcing in the pharmaceutical industry is the strategic decision to produce products at a contract manufacturer (CMO and CDMO). There can be numerous reasons for shifting a production chain to an external supplier. The decisive factors are often:
1. costs and cost structure
Contract manufacturers specialise in low-cost and fast production.
Outsourcing to improve cost efficiency can significantly improve the competitive position
2. flexibility in production
Contract manufacturers are usually more flexible with batch sizes and have different ruler technologies available. This results in much better flexibility in manufacturing and can result in shorter replenishment times.
3. the production know-how is not available internally
Many products in biotechnology are developed by start-ups. Naturally, there are no or only very limited production possibilities there. The path to contract manufacturers is the only way to produce industrial quantities under GMP conditions and bring them to market.
1. costs and cost structure
Many companies only look at the manufacturing costs of an external supplier and make the decision to produce there based on this. However, the total costs incurred by the transfer and the establishment at a contract manufacturer are decisive.
When transferring an existing production to a new supplier, costs are incurred that are usually not directly attributed to the transfer but should be considered for the overall profitability. These include, for example, the cost of technical batches at the new supplier, adapting the manufacturing method to the equipment and procedures of the contract manufacturer, costs for validations, costs for changing the registration dossier and the largest cost item:
the duration of the transfer project including the costs of all departments and persons involved. During the project period, costs are incurred twice. Once in the company's own production, which it has not yet transferred, and the entire transfer costs including trials in the new production facility. It is this period in particular, together with the associated activities, that decides to a large extent on the total costs of the production transfer and on the success or failure of the outsourcing.
It is therefore of paramount importance to carefully plan and quickly execute such outsourcing production transfers. The differences between a quick, clean production transfer and a relatively elaborate, multi-year project could quickly exceed millions.
2. flexibility in production
In general, contract manufacturers are actually optimised to produce diverse and different products quickly and efficiently. However, this focus on low manufacturing costs often leads to very large batch sizes and thus indirectly to very long lead times for production.
If the selection of the contract manufacturer is exclusively focussed on "costs", it is very easy to get caught in a vicious circle of very large manufacturer lots, long replenishment cycles and, as a result, very poor flexibility in manufacturing. Which company can predict with a high degree of certainty the sales figures for the year after next?
The order of the day in most, if not all, companies is short-term rescheduling, changes in sales volumes in various markets due to, for example, regulatory changes or price changes, or simply changes in the priority of products.
On the whole, one is therefore usually better off with CMOs that can offer shorter replenishment times. The manufacturing costs are higher, but the risk that the goods in the warehouse already lose a large part of their value (due to the limited shelf life) is significantly reduced.
It often happens, for example, that packages have to be adapted due to regulatory changes. If you then still have large quantities of your product in stock because your contract manufacturer only produces competitively in very large batch sizes, you will of course write a large loss here.
Manufacturing costs, batch sizes, minimum order quantities, flexibility in production planning are a very delicate mix that has to be redefined for each product and each contract manufacturer.
When transferring an existing production to a new supplier, costs are incurred that are usually not directly attributed to the transfer but should be considered for the overall profitability. These include, for example, the cost of technical batches at the new supplier, adapting the manufacturing method to the equipment and procedures of the contract manufacturer, costs for validations, costs for changing the registration dossier and the largest cost item:
the duration of the transfer project including the costs of all departments and persons involved. During the project period, costs are incurred twice. Once in the company's own production, which it has not yet transferred, and the entire transfer costs including trials in the new production facility. It is this period in particular, together with the associated activities, that decides to a large extent on the total costs of the production transfer and on the success or failure of the outsourcing.
It is therefore of paramount importance to carefully plan and quickly execute such outsourcing production transfers. The differences between a quick, clean production transfer and a relatively elaborate, multi-year project could quickly exceed millions.
3. the production know-how is not available internally
You have developed a new product and now want to produce it. Establishing your own production, including construction of the necessary buildings, purchase of the equipment, etc. would take several years and require a massive capital investment. You have no other option than to find a competent contract manufacturer who can take over the production. Again, the manufacturer's price is not the all-important parameter, as it is more important to have a solid development data that can also support the scale-up of the developed product, is analytically powerful and can also technologically master the necessary adjustments. These requirements are by far not fulfilled by all C(D)MOs. It is advisable to check carefully whether the promised technological competence is actually available.
We advise you independently and represent your interests with suppliers and contract manufacturers.
Good Practice Guide: Project Management for the Pharmaceutical Industry
What Does Contract Manufacturing Look Like In Pharma?
Many factory productions can be outsourced to contract manufacturers (CMs) in order for businesses to continue providing quality products to their customers in a cost-effective way, and so they can focus on other aspects of their business, increasing their overall productivity and efficiency, and improving their bottom line.
ment for the Pharmaceutical Industry | ISPE | International Society for Pharmaceutical Engineering