From Pilot to Production: Scaling Up Pharmaceutical Gummies

Pharmmies just ran its pharmaceutical gummy formulations on industrial production equipment for the first time, and Bold Maker™ designed the molds. The campaign covered a Paracetamol 160 mg gummy and an Ibuprofen 100 mg gummy, processed at roughly 10% of the intended commercial batch size.

The goal was not a sales run. It was to generate and document the process data and key operating parameters Pharmmies will need to transfer production to a Good Manufacturing Practice (GMP) contract manufacturer (CMO). That is the step where many promising gummy products stall, and it is worth looking at what a well-run scale-up campaign actually involves.

Why pharmaceutical gummies scale differently

A pharmaceutical gummy is a dosage form first and a confection second. Every piece has to carry the labeled amount of active ingredient, which makes dose uniformity the requirement everything else serves.

That changes what "it works on the bench" means. A formulation that sets nicely in a lab mold can behave differently in a production depositor: hold times get longer, mass temperature drifts across a batch, viscosity shifts, and fill weight starts to vary between cavities. Each of those affects how much active ends up in each gummy.

A pharmaceutical gummy is a dosage form first and a confection second.

Gummies destined for a CMO also need a process the CMO can reproduce, validate, and run under GMP. A recipe alone does not get you there. The CMO needs defined parameters, acceptable ranges, and the data showing why those ranges hold.

As the Pharmmies team points out, quality, precision, regulatory compliance, and reproducibility are fundamental to pharmaceutical development and manufacturing. Moving from pilot to commercial production takes careful planning, disciplined execution, and thorough verification to make sure the process performs consistently as intended. There is little room for error, so each step must be designed, tested, and confirmed before moving forward.

What a tech-transfer prep run should produce

The value of a run like Pharmmies' is in the documentation it leaves behind. Running at about 10% of commercial scale on industrial equipment is large enough to expose real production behavior, and small enough to keep material costs and risk manageable.

A well-structured campaign typically captures:

• Process parameters such as cooking and holding temperatures, mass temperature at deposit, depositing speed, and curing or setting conditions.
• Operating ranges, not just set points, so the CMO knows how much variation the product tolerates.
• Critical controls that tie each parameter to a quality attribute like fill weight, piece weight, or appearance.
• Equipment and tooling details, including the molds, so the receiving site can match or justify what it uses.

Pharmmies describes its approach as structured development: defining and documenting the parameters and controls needed for consistent quality and an efficient, reproducible process. That package is what turns a formulation into something a CMO can take on with confidence.

Molds are part of the product, not just the process

For this campaign, Bold Maker™ developed product-specific molds for Pharmmies with an embossed identifier and a score line on each gummy. The design was built around the intended US product presentation.

In a pharmaceutical product, those details carry real weight:

• An embossed identifier helps patients, caregivers, and pharmacists recognize the product and tell strengths apart.
• A score line shows where a gummy is meant to be divided, which matters for products where dosing may be adjusted.
• Cavity consistency across the mold supports uniform piece weight, which in turn supports uniform dose.

This is why mold design belongs in tech-transfer planning from the start. Evaluating the molds during the scale-up run, rather than after, means the tooling is tested under real production conditions and documented alongside the process parameters. A late tooling change can force parts of that work to be repeated.

This is why mold design belongs in tech-transfer planning from the start.

Bold Maker™ designs and manufactures custom silicone and polycarbonate molds for confectionery, nutraceutical, and pharmaceutical producers, from early development through production-scale tooling.

Preparing your own gummy for CMO transfer

If you are developing a pharmaceutical or nutraceutical gummy, these are the questions worth answering before you hand it to a manufacturing partner:

1. Has the formulation been run on production-type depositing equipment, not only in the lab?
2. Are key process parameters documented as ranges, with data showing the product stays in spec across them?
3. Do you know which parameters most affect fill weight and dose uniformity?
4. Is the mold design final, including any identifiers, score lines, or market-specific presentation?
5. Has the tooling been evaluated under the same conditions the CMO will run?
6. Can the receiving site source or reproduce the same molds?

A scale-up run at a fraction of commercial batch size is often the most efficient way to answer most of these at once.

A collaborative milestone

We congratulate the Pharmmies team on reaching this stage, in collaboration with Bold Maker™ who provided the molds, and Tanis, who have provided the industrial depositing systems. 

We are proud to support pharmaceutical gummy developers as they move from formulation to commercial manufacturing.

Planning a scale-up or tech transfer? Talk to Bold Maker about custom molds designed for your product, your dose, and your target market. 

Images provided courtesy of the Pharmmies team, used with permission.