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What it says on the tin: How to choose the right contract manufacturer
As a leading company for contract manufacturing and contract packaging, we share our knowledge of what is important when choosing the right contract manufacturer.
25.04.2024
15 min
Working with a developer and contract manufacturer, hereinafter referred to as a Contract Development Manufacturing Organization (CDMO), under Good Manufacturing Practice (GMP) appears complex at first glance. But appearances are deceptive. After all, if certain requirements for a successful partnership are met, the desired quality product will be created. The following must be observed:
Communication is the be-all and end-all in contract manufacturing. It is therefore important to let the CDMO know from the outset which development phase the product is in: For example, active ingredient discovery, preclinical studies (testing on animals) or clinical studies (testing on humans). Is active substance development, galenic development or sample blinding required for clinical trials? Sample blinding for clinical trials requires a license, which Hänseler Swiss Pharma, for example, has. This gives customers the opportunity to have new medicinal products delivered in usually smaller batches so that they can be scientifically tested on humans (clinical trials).
An experienced contract manufacturer is familiar with the manufacturing of various galenic forms such as solid, semi-solid and liquid and also has extensive knowledge in the area of packaging. The partners should be able to benefit from this specialist knowledge at all times.
A central point that must be taken into account when working with a CDMO is the approval and legal status of the product to be manufactured: The contract manufacturer must know which approval the product already has or which approval is being sought (e.g. Swissmedic, European Community Directive 2001/83/EC, US FDA). And: What legal status the product should have in the target market (e.g. medicinal product, active pharmaceutical ingredient (API), excipient, food supplement, cosmetic, medical device, chemical).
The most valuable asset in the manufacture of a product is quality assurance. An experienced contract manufacturer guarantees the standards of Good Manufacturing Practice (GMP) thanks to state-of-the-art technology and a high level of expertise. Compliance with these standards guarantees maximum reliability and purity in the manufacture of medicinal products, food supplements and cosmetics. GMP is mandatory for pharmaceutical manufacturers. It is therefore essential that the CDMO receives detailed information about the quality, analytics, stability and required documentation of the product.
Which raw materials are required for the specialty product? Will these be supplied to the contract manufacturer or will the latter handle the sourcing? Here it is worth choosing a CDMO that places high demands on its suppliers, has a wide range of raw materials and produces some of them itself. The manufacturer should also have a broad and, if possible, direct network of suppliers so that the customer receives the best possible raw materials at attractive prices and a high level of reliability in the supply chain can also be guaranteed.
What should the product look like, how should it be packaged - and what is the required batch size? It is important for the CDMO to know whether it is a liquid, semi-solid or solid product. In order to be able to plan this optimally, the CDMO must know the batch size, the requirement and the first delivery date at an early stage. And also how the product is to be delivered: Will it be further processed or ready to be filled and packaged? Containers and packaging must also be discussed in advance. How flexible and innovative is the CDMO? Are customer-specific solutions possible or not?
“50% of recalls are due to stability problems” (Dr. Christoph Titze, responsible person at Hänseler Swiss Pharma). Think about the desired shelf life of the products and the required stability at an early stage. The packaging material must be precisely tailored to the preparation of the product in order to achieve the required stability. This is why glass, for example, is so popular in the pharmaceutical industry: glass is inert - most substances do not change on contact with glass.
The glass bottle is popular: however, a glass bottle is not always the right solution. In addition to the chemistry, the dosage also needs to be considered: For example, the dosage for anesthetics is very strict - droplets from a bottle are far too imprecise - in a tablet, on the other hand, the dosage is precise. Last but not least, the packaging must also be practical: there was one customer, for example, who wanted to offer a self-medication that was to be introduced into the body anally with a tube of militer precision. He forgot the practical aspect that exact dosing is very difficult with this kind of self-medication - the tube would have to be squeezed out completely and inserted in exactly the right place - impossible. That is why a good CDMO is able to advise customers on the chemical, regulatory and practical aspects.
Choosing a suitable contract manufacturer is a crucial step for companies. It is worth considering the key factors mentioned above. In this way, a partnership can be established that meets the specific needs and requirements of the customer.
Where do you stand?
Communication is the be-all and end-all in contract manufacturing. It is therefore important to let the CDMO know from the outset which development phase the product is in: For example, active ingredient discovery, preclinical studies (testing on animals) or clinical studies (testing on humans). Is active substance development, galenic development or sample blinding required for clinical trials? Sample blinding for clinical trials requires a license, which Hänseler Swiss Pharma, for example, has. This gives customers the opportunity to have new medicinal products delivered in usually smaller batches so that they can be scientifically tested on humans (clinical trials).An experienced contract manufacturer is familiar with the manufacturing of various galenic forms such as solid, semi-solid and liquid and also has extensive knowledge in the area of packaging. The partners should be able to benefit from this specialist knowledge at all times.
Where should the product be approved?
A central point that must be taken into account when working with a CDMO is the approval and legal status of the product to be manufactured: The contract manufacturer must know which approval the product already has or which approval is being sought (e.g. Swissmedic, European Community Directive 2001/83/EC, US FDA). And: What legal status the product should have in the target market (e.g. medicinal product, active pharmaceutical ingredient (API), excipient, food supplement, cosmetic, medical device, chemical).
What does it take to achieve the highest quality?
The most valuable asset in the manufacture of a product is quality assurance. An experienced contract manufacturer guarantees the standards of Good Manufacturing Practice (GMP) thanks to state-of-the-art technology and a high level of expertise. Compliance with these standards guarantees maximum reliability and purity in the manufacture of medicinal products, food supplements and cosmetics. GMP is mandatory for pharmaceutical manufacturers. It is therefore essential that the CDMO receives detailed information about the quality, analytics, stability and required documentation of the product.
What about raw materials?
Which raw materials are required for the specialty product? Will these be supplied to the contract manufacturer or will the latter handle the sourcing? Here it is worth choosing a CDMO that places high demands on its suppliers, has a wide range of raw materials and produces some of them itself. The manufacturer should also have a broad and, if possible, direct network of suppliers so that the customer receives the best possible raw materials at attractive prices and a high level of reliability in the supply chain can also be guaranteed.
What and how much should be produced?
What should the product look like, how should it be packaged - and what is the required batch size? It is important for the CDMO to know whether it is a liquid, semi-solid or solid product. In order to be able to plan this optimally, the CDMO must know the batch size, the requirement and the first delivery date at an early stage. And also how the product is to be delivered: Will it be further processed or ready to be filled and packaged? Containers and packaging must also be discussed in advance. How flexible and innovative is the CDMO? Are customer-specific solutions possible or not?
Recalls - proactively reducing the risk of a super-failure
“50% of recalls are due to stability problems” (Dr. Christoph Titze, responsible person at Hänseler Swiss Pharma). Think about the desired shelf life of the products and the required stability at an early stage. The packaging material must be precisely tailored to the preparation of the product in order to achieve the required stability. This is why glass, for example, is so popular in the pharmaceutical industry: glass is inert - most substances do not change on contact with glass.
The packaging material is crucial
The glass bottle is popular: however, a glass bottle is not always the right solution. In addition to the chemistry, the dosage also needs to be considered: For example, the dosage for anesthetics is very strict - droplets from a bottle are far too imprecise - in a tablet, on the other hand, the dosage is precise. Last but not least, the packaging must also be practical: there was one customer, for example, who wanted to offer a self-medication that was to be introduced into the body anally with a tube of militer precision. He forgot the practical aspect that exact dosing is very difficult with this kind of self-medication - the tube would have to be squeezed out completely and inserted in exactly the right place - impossible. That is why a good CDMO is able to advise customers on the chemical, regulatory and practical aspects.How big is the contract manufacturer's market presence?
Some CDMOs, such as Hänseler Swiss Pharma, also offer their customers market access in certain regions. This is an important point, as they can offer a corresponding distribution network for the product in wholesale and retail, including drugstores, pharmacies, hospitals, clinics, etc.
Conclusion
Choosing a suitable contract manufacturer is a crucial step for companies. It is worth considering the key factors mentioned above. In this way, a partnership can be established that meets the specific needs and requirements of the customer.