At Adragos Leipzig, quality is at the heart of everything we do. We specialise in non-sterile liquid manufacturing, including cough syrups and other liquid medicines, as well as semi-solid manufacturing for products such as creams, gels and ointments. While these products do not need to be manufactured under aseptic conditions, maintaining robust quality standards remains essential to protect patient safety.
Non-sterile liquid manufacturing and semi-solid manufacturing capabilities
As a non-sterile liquids CDMO, we manufacture a wide range of products, from very small runs through to batch sizes of 4000 L. Our portfolio includes simple solutions, formulations containing thickening agents such as xanthan gum, suspensions and emulsions. Alongside oral liquid manufacturing, we also support semi-solid manufacturing for creams and ointments. Our capabilities extend beyond pharmaceuticals into food supplements and cosmetics.
Oral liquid manufacturing across a wide product range
Our non-sterile liquid manufacturing capabilities cover multiple formulation types and production scales. We also have a new filling line that allows us to work with liquid products with a very high alcohol content. This gives customers additional flexibility when developing and commercialising complex oral liquid and topical liquid products.
Semi-solid manufacturing for creams, gels and ointments
For semi-solids, consistency across the batch is critical. Whether the product is a cream, gel or ointment, process control must ensure uniformity so that quality and dosing remain reliable from the start of the batch to the end. This is especially important for pharmaceutical products where batch homogeneity has a direct impact on product performance and patient use.
Scaling from galenical batches to commercial production
As products move from small-scale production to larger volumes, a number of manufacturing challenges must be addressed. Mixing is critical for liquid products, and the right technology must be selected for the viscosity and behaviour of the formulation. Our smallest mixer, with a volume of 15 L, is well suited to galenical-scale runs and can also support very small specialist production batches. From there, production can scale through 1200 L and up to our largest 4000 L vessel.
Moving from a 15 L batch to commercial-scale output is not simply a matter of increasing volume. Process behaviour changes with scale. A mixing step that is straightforward in a small vessel becomes much more complex at industrial scale, particularly where dissolution, suspension stability or emulsion performance must be maintained consistently. This is why scale-up work must be approached in a structured and data-led way.
Process validation for non-sterile manufacturing
In the pharmaceutical environment, process validation for non-sterile manufacturing is central to demonstrating control. At Adragos Leipzig, risk assessments are used to identify critical process points, and data from pilot runs support scale-up into larger batches. As batch sizes increase for non-sterile liquids, additional supporting data may be required. For semi-solids, additional homogeneity studies are needed to demonstrate consistency throughout the batch.
Validation, data integrity and GMP expectations
For pharmaceutical products in Europe, Annex 15 of EU GMP addresses qualification and validation. The current article also refers to validation of computerised systems and data integrity, covering both networked and standalone equipment used to generate and record manufacturing and laboratory data. That aligns with the broader GMP expectation that validated processes and reliable records support product quality and release decisions.
Pharmaceutical tech transfer at Adragos Leipzig
Many of the products we manufacture were originally developed elsewhere and then transferred into our facility. Our team in Leipzig works with customers on the full pharmaceutical tech transfer plan. This includes key areas such as raw materials, packaging, analytical method transfer and manufacturing readiness. Where appropriate, established supplier relationships can also reduce analytical burden and improve efficiency, particularly when already qualified or validated suppliers are used.
Where product from a previous production run is available, it can support method transfer and analytical method validation. This work can run in parallel with galenical batches so that the programme is ready for the first pilot batch or full-scale production. Every step still requires full validation, including final packaging, before batch release.
Microbial control and stability across product categories
The process is simpler for food supplements and cosmetics than for pharmaceutical products because full pharmaceutical validation is not always required in the same way. However, microbial control remains important across all categories. The current page explains that pharmaceutical batches are typically tested batch by batch, while cosmetics may be tested at a lower frequency depending on the product specification and risk profile.
Microbial testing of raw materials is not always required, but exceptions may apply where the material provides a favourable environment for microbial growth, such as liquid sugar solutions, or where an opened container has exceeded its retest date. Ongoing stability is important. For pharmaceuticals, this includes ICH stability studies, while for cosmetics stability remains important for setting expiry dates and understanding how the product behaves under transport or temperature stress. ICH quality guidance identifies stability testing as the basis for understanding how quality changes over time under environmental factors such as temperature and humidity.
Reliable manufacturing for patients and consumers
Quality means reliability at every step of manufacturing. Careful process control, continuous monitoring and a structured validation approach help identify and address issues before they become wider problems. For customers, that means a more dependable route from development and transfer to commercial supply. For patients and consumers, it means products that consistently meet specification and are safe to use.
