Hi, I’m Paul Malone, Senior Project Scientist at Biofortuna.

Moving a lyophilised assay from development to large-scale manufacturing is never simply a case of just “scaling-up”.

In fact, the process introduces unique challenges that can compromise your product’s performance and compliance if ignored.

At Biofortuna, we focus on three key considerations to ensure your assay maintains consistency, reliability and quality at every stage.

The first major consideration is Freeze Dryer Compatibility.

The equipment used for pilot batches is fundamentally different from large-scale manufacturing units. Variations in shelf space, condensing efficiency and heat transfer can drastically alter the final product.

That’s why we design the lyophilisation protocols with manufacture in mind.

We have the option to utilise the same freeze dryer from development to manufacturing or use similar equipment throughout, saving time and resources.

We also use analytical techniques of Freeze Drying Microscopy and Differential Scanning Colorimetry to identify the critical formulation characteristics of collapse temperature and glass transition temperature.

This allows us to optimise the Freeze drying process and acts as a key quality checkpoint during transfer.

Formulation is another consideration.

Scaling up batch sizes from pilot to manufacturing scale requires a bespoke approach to formulation and process design.

Optimising the mixing protocol prevents issues such as precipitation and loss of homogeneity.

We also need to consider stability. The wet assay has a limited dispensing window before degradation so making the right format and automation of the dispensing process critical.

Once lyophilised, we measure the glass transition temperature to define the required storage conditions and shelf life. This is our starting point to navigate the challenges that come with product transportation.

Every formulation is unique, demanding a tailored approach.

Finally, quality control must be rigorous and continuous throughout.

Incoming Goods QC are functional tests to ensure your raw materials perform as expected. This due diligence helps to avoid the risk of costly failures later.

After lyophilisation, we conduct Physical QC, measuring residual moisture content and hardness, as well as performing high resolution imaging and reconstitution tests to confirm the products robustness.

Finally, Finished Goods QC confirms the final products meets its specifications.

And most importantly, full traceability must be maintained – from goods in to goods out. This commitment to quality and ISO 13485 is essential for producing reliable and reproducible assays at scale.

Each of these considerations plays a crucial role in safeguarding assay performance during development and manufacture.

At Biofortuna, we provide end-to-end support, accelerating formulation, supporting regulatory requirements whilst reducing the overall time and cost of bringing your assay to market.

So, if you’re ready to ensure a reliable transition for your product, contact us today.