As drug product formulations become more sophisticated, pharmaceutical manufacturers must overcome a set of unique challenges to stabilise otherwise sensitive compounds for transport and storage.
Incorporated into biomanufacturing before the final fill-finish step, lyophilisation is the process of freeze-drying to remove water/other solvents from a product. This is achieved via a process known as sublimation which transforms frozen liquids into a gaseous state, surpassing the liquid phase entirely. This gas is then collected in a condenser and any residual liquid is driven off as the temperature is slowly raised, leaving behind a stabilised powder.
In this blog, we will explore lyophilisation and discuss how it’s typically incorporated into current manufacturing processes by expert contract manufacturing partners.
Industry drives toward lyophilisation
Lyophilisation is a widely used technique within the biopharma industry for a range of modalities including: large molecules, antibody-drug conjugates, proteins and antibodies. Freeze-drying can constitute a large proportion of a manufacturer’s budget but the investment is realised once the product can then be transported and stored with ease.
Due to both the sophisticated techniques and equipment necessary to process compounds in this manner, a knowledgeable partner is crucial to develop economical freeze-drying cycles, at scale. Given the wide range of molecular characteristics spanning drug products, a one size fits all approach to lyophilisation is highly unlikely to yield meaningful results. Each product must be assessed on a case-by-case basis by a knowledgeable technical team.
As the industry shifts towards using biological materials to address the unmet needs of patients, there is an increasing requirement to overcome these associated barriers to production. This is reflected in the value of the lyophilisation market, estimated at $252.8 billion in 2022, with a compound annual growth rate of 13% forecast to 2033.²
The benefits of a lyophilised product
There are several clear advantages to utilising this specialist technique within your drug manufacturing protocols:
Stability refers to the ability of a pharmaceutical product to retain its fundamental properties e.g. chemical, physical, microbiological and biopharmaceutical. Two of the most important factors to maintain product stability are moisture and oxygen. The lyophilisation process ensures as little moisture and oxygen remain as possible to improve drug product long-term stability. This is why it’s of the utmost importance that packaging used for lyophilised materials is also impermeable to atmospheric moisture. Thus, retaining the benefits of the freeze-drying process.
Storage of drug products can also be an expensive outlay when compounds must be maintained within a very narrow range of extreme parameters. However, post-lyophilisation, freezing or cryogenic temperatures are bypassed for a less complex cold fridge or ambient storage rack.
Transport of freeze-dried drug product is more economical versus products which have not been lyophilised due to the reduced overall weight. Furthermore, specialist logistics contracts are no longer necessary because extreme temperatures are no longer appropriate for transport.
Integrity of drug products is of the utmost importance to safeguard drug potency and deliver the therapeutic payload patients require for successful treatment. Moisture is one of the crucial factors contributing to the degradation of active ingredients. By removing 95% of water from compounds lyophilisation preserves drugs without negatively impacting the efficacy of active ingredients. Furthermore, lyophilised products can return to its original state with no impact on the potency of the API through rehydration.
Choosing the right partner
Developing lyophilisation cycles for specific, desired results is a complex task that only specialist teams can achieve rapidly. In the wrong hands, lyophilisation optimisation and implementation can take several months and can severely inflate outlays.
Partnering with a contract manufacturing organisation with extensive expertise in developing lyophilisation cycles allows drug developers to confidently produce stable drug products whilst mitigating against delays.
If you’re looking for a proven track record of delivering lyophilised projects across a range of modalities, contact Symbiosis today to discover how you’ll accelerate your next project with confidence.