Batch size planning for semi-solid CDMO production is one of the least glamorous and most consequential decisions in a commercial programme. Choose a batch size that is too large and you tie up capital, risk waste and lose flexibility. Choose one that is too small and you pay for constant changeovers and struggle to meet demand. This guide sets out the batch ranges and filling formats available for creams, gels, ointments and non-sterile liquids, and the outsourcing criteria that reduce scale-up risk.
Table of contents
- What is batch size planning for semi-solid CDMO production?
- Semi-solid batch sizes: creams, gels and ointments
- Non-sterile liquid batch sizes
- Filling formats: tubes and bottles
- How batch size affects scale-up risk
- Outsourcing criteria that reduce scale-up risk
- How Adragos supports semi-solid production at Leipzig
- Frequently asked questions
What is batch size planning for semi-solid CDMO production?
Batch size planning for semi-solid CDMO production is the exercise of matching your commercial volume, your demand pattern and your packaging format to the batch ranges a manufacturing site can actually run. It sounds like a supply chain detail, but it shapes your cost per unit, your inventory, your shelf life exposure and how quickly you can respond to a change in demand. The right answer is rarely the biggest batch. It is the batch that fits the product and the market.
Semi-solid batch sizes: creams, gels and ointments
Semi-solid dosage forms cover creams, gels, ointments and healing pastes, and they are typically produced in vessels measured in litres rather than units. When you assess a site, ask for the full range it can run, not just the maximum. A wide range is what gives you room to launch small and grow.
At our Leipzig site in Germany we run two semi-solid production lines, Marchesini and Norden, with batch sizes from 15 litres up to 1,250 litres. That lower end matters: a 15 litre batch makes it viable to produce registration batches, launch quantities or a niche product without committing to a full commercial run.
Non-sterile liquid batch sizes
Non-sterile liquids include solutions, drops, suspensions and emulsions, and they usually run at larger volumes than semi-solids. Our Leipzig site operates three liquid production lines, Dovema, Würschum and Groninger, with batch sizes of up to 4,000 litres. The practical point for planning is that semi-solids and liquids sit on different lines with different ranges, so a portfolio containing both should be assessed against each range separately rather than assuming one number covers everything.
Filling formats: tubes and bottles
Batch size is only half of the decision. The filling format determines how that bulk reaches the patient, and it constrains what is possible. Confirm the formats a site can fill before you fix a batch size:
- Tubes for semi-solids: plastic tubes from 25 g to 200 g, and aluminium tubes from 2 g to 150 g.
- Bottles for liquids: plastic and glass bottles from 20 ml to 700 ml.
Those ranges are worth checking early. A 2 g aluminium tube and a 700 ml glass bottle are very different propositions, and a site that covers both gives you options as the portfolio evolves.
How batch size affects scale-up risk
Scale-up risk rises when the batch size you validate is far from the batch size you will actually run. A process proven at 15 litres does not automatically behave the same at 1,250 litres, because mixing, heating and homogenisation all change with volume. Plan for this by choosing a site whose range covers both your launch volume and your target commercial volume, so the process can grow within the same equipment family rather than being revalidated somewhere new. The International Council for Harmonisation quality guidelines set out the development and validation principles that underpin a controlled scale-up. The fewer scale jumps and site changes, the lower the risk to your timeline.
Outsourcing criteria that reduce scale-up risk
When you compare CDMO services for pharma, weigh these criteria before you commit:
- Does the batch range cover both your launch volume and your commercial target?
- Can the site fill the tube or bottle format your product needs?
- Are semi-solids and non-sterile liquids handled on dedicated lines?
- Does the site hold EU-GMP certification for the product types you make?
- Can it handle controlled substances, if your portfolio requires it?
- Is there room to grow without a change of site?
How Adragos supports semi-solid production at Leipzig
Our Leipzig site has one hundred years of experience and specialises in semi-solid and non-sterile liquid pharmaceuticals. In practice that gives you:
- Semi-solids: two lines (Marchesini and Norden), batches from 15 to 1,250 litres, filled into plastic tubes (25 g to 200 g) and aluminium tubes (2 g to 150 g).
- Non-sterile liquids: three lines (Dovema, Würschum and Groninger), batches up to 4,000 litres, filled into plastic and glass bottles from 20 ml to 700 ml.
- Controlled drugs handling for portfolios that require it.
- EU-GMP certification for both human and veterinary products.
That span, from a 15 litre batch to a 4,000 litre batch, means a product can launch small and scale up without leaving the site. To plan a batch strategy for a specific product, contact our team. For the wider quality picture, see our guide on GMP compliance for CDMO manufacturing.
Frequently asked questions
What batch sizes are typical for semi-solid production?
Semi-solid batches are measured in litres and vary widely by site. At our Leipzig site the range runs from 15 litres to 1,250 litres, which covers registration batches at the low end and commercial runs at the high end.
Why are semi-solid and liquid batch sizes different?
They run on different lines with different equipment. Non-sterile liquids are typically produced at larger volumes, up to 4,000 litres at our Leipzig site, while semi-solids are limited by mixing and homogenisation equipment.
How do I choose the right commercial batch size?
Match it to your demand pattern, your shelf life and your filling format, then confirm the site can run both your launch volume and your commercial target. Validating close to your real running volume reduces scale-up risk.
What filling formats are available for creams and ointments?
Semi-solids are commonly filled into tubes. Our Leipzig site fills plastic tubes from 25 g to 200 g and aluminium tubes from 2 g to 150 g, while non-sterile liquids go into plastic and glass bottles from 20 ml to 700 ml.
