Pharmaceutical CDMOs: key advantages and challenges of pharmaceutical outsourcing

In the pharmaceutical manufacturing ecosystem, pharmaceutical CDMOs (Contract Development and Manufacturing Organizations) play a major role.

By integrating packaging into their production chain, they provide brands and laboratories with reliable technical solutions that comply with regulatory requirements.

Container of a drug monitored by pharmaceutical CDMOs.

In the pharmaceutical manufacturing ecosystem, pharmaceutical CDMOs (Contract Development and Manufacturing Organizations) play a major role.

By integrating packaging into their production chain, they provide brands and laboratories with reliable technical solutions that comply with regulatory requirements.

This article examines how CDMOs can offer expert technical solutions to meet the regulatory and industrial challenges of their clients.

1. What is CDMO or pharmaceutical outsourcing?

CDMO stands for Contract development and manufacturing organization.

A pharmaceutical CDMO is a subcontracting company in the pharmaceutical industry. It handles one or more stages of the production chain:

  • Formulation
  • Development
  • Manufacturing
  • And sometimes packaging…

A CDMO works on behalf of laboratories, pharmaceutical brands, or dietary supplement manufacturers.

The concept of a pharmaceutical CDMO therefore refers to a specialized industrial partner that supports its clients in the technical and regulatory implementation of their products, up to the final packaging.

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    2. Primary packaging: an essential link in pharmaceutical manufacturing

    a. The role of primary packaging

    products and dietary supplements. It is the first packaging that comes into direct contact with the active substance.

    In addition to its role as a container, it directly contributes to the safety, stability, and quality of the product. It protects the active ingredient from oxidation, moisture, light, Primary packaging is a major component in the manufacturing of pharmaceutical and contamination, ensuring optimal preservation until final use.

    b. Choosing the right primary packaging

    In the pharmaceutical and nutraceutical industries, primary packaging is strictly regulated and must comply with the standards of the European Pharmacopoeia.

    Calling upon a pharmaceutical CDMO ensures the security of this step. With its technical and regulatory expertise, the pharmaceutical CDMO helps clients make the right primary packaging choices. It can also integrate this choice into a comprehensive manufacturing process, ensuring consistency, compliance, and industrial performance.

    To learn everything about primary packaging of drugs, check out our dedicated article.

    Role of CDMOs in monitoring pharmaceutical packaging.

    3. The services offered by pharmaceutical CDMOs

    a. The services provided by pharmaceutical CDMOs

    Today, pharmaceutical CDMOs offer comprehensive services, covering all stages of the manufacturing of a health or nutrition product, including its packaging:

    • Galeniс development: formulation of the product, selection of excipients, stability optimization.
    • Analytical development: definition of quality control methods, stability tests, process validation.
    • Industrial manufacturing: production at the pilot or commercial scale, according to Good Manufacturing Practices (GMP).
    • Filling: transferring the formula into consumer units, in liquid, powder, capsule, or other forms.
    • Primary packaging: filling and sealing in the packaging in direct contact with the product.
    • Secondary packaging: labeling, instructions, cartons, and box packing.

    Primary packaging is therefore integrated into the manufacturing process, with equipment tailored to the dosage forms and specific materials.

    b. The advantages of working with a CDMO

    Partnering with a pharmaceutical CDMO offers several benefits for laboratories and brands, including:

    • Access to expertise: providing support in selecting the appropriate primary packaging for the formula and intended use, while considering technical and regulatory constraints.
    • Time savings: through centralized coordination of production stages, reduced lead times, and no interruptions between development and packaging phases.
    • Cost reduction: with economies of scale, resource pooling, and the elimination of logistical transfers between subcontractors.
    • Process security: with validated equipment, trained staff, and a controlled environment (cleanrooms, controlled atmospheres).
    • Quality control: with integrated monitoring, ensured regulatory compliance, and full traceability of batches.
    • Flexibility: with the ability to adjust production volumes according to needs (small or large batches).
    • Access to innovations: with the integration of patented or exclusive solutions, such as vacuum filling or secure opening systems.
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      4. Calling upon a pharmaceutical CDMO for your primary packaging

      a. A CDMO for liquid dietary supplements

      Liquid dietary supplements present specific challenges in formulation and packaging. Many plant extracts, vitamins, or natural active ingredients are sensitive to oxidation, light, or heat. Their stability mainly depends on the choice of primary packaging.

      A pharmaceutical CDMO provides a comprehensive technical solution to these challenges. It selects packaging suited to the nature of the product, considering protection, preservation, and regulatory compliance requirements. It may recommend the use of glass containers (ILLAX® Type III glass or FIOLAX® Type I), such as double-tip ampoules, combined with vacuum filling to minimize the presence of air.

      This solution helps extend the product’s shelf life while ensuring maximum protection of the active ingredients. Additionally, devices like the DRB (Double Ring Break), a patented expertise by SFAM, pre-determining the breaking point, secure the opening and minimize the risk of glass particles, a critical concern in the field of consumable products.

      To learn more about the types of pharmaceutical glass, read our full article.

      CDMO pharmaceutical glass manufacturer.

      b. A CDMO for the packaging of sensitive injectable drugs

      Injectable medications have high requirements in terms of stability, sterility, and safety. The active ingredients they contain can be unstable when exposed to light, air, or certain contaminants.

      A pharmaceutical CDMO has the expertise required to select suitable materials, such as Type I borosilicate glass, which complies with the European Pharmacopoeia standards. This material offers very high chemical and thermal resistance, making it the standard for sensitive injectable solutions.

      The CDMO can also go beyond the production of primary packaging by implementing automated vacuum filling processes carried out in controlled environments.

      Primary packaging is a technical and strategic element of pharmaceutical manufacturing. Its quality directly impacts the safety, stability, and compliance of the finished product.

      By integrating primary packaging into their overall offering, pharmaceutical CDMOs are able to meet these requirements. Their expertise allows them to select the right materials, optimize filling processes, and ensure compliance with regulatory standards.

      Therefore, calling upon a CDMO ensures the security of each production step with a single expert market partner. It is also a lever to save time, reduce costs, and improve the overall quality of the product.

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