Optimizing Biopharmaceutical Excellence: Cost-Efficiency and Accelerated Development Strategies

Sponsored by Biopharma Group

The pharmaceutical industry is a constantly evolving and highly competitive field, with companies always looking for ways to improve their processes and bring new products to market faster. One key area is related to the development and manufacturing of oncological products. These are some of the most expensive drugs on the market, whether they are standalone high potent active ingredient or conjugated with biologics such as antibodies or peptides, with prices often reaching hundreds of thousands of dollars per patient. This is why it is crucial for companies producing oncological products to find ways to reduce costs and improve efficiency.

One area where significant savings can be made is in the lyophilisation process. Lyophilisation, also known as freeze-drying, is a process used to preserve delicate drug substances, such as biologicals that are sensitive to high temperature, by removing water. Lyophilisation also allows for storing the drug product for longer at room temperature, removing the challenges and economical disadvantages associated with the cold chain. One major cold-chain challenge is the requirement of specialised equipment and infrastructure, which can be expensive to implement and maintain. Additionally, the cold chain can also be vulnerable to power outages and other disruptions, which can lead to product spoilage and loss. This can limit the reach of these products and make it difficult to provide them to people in need. Hence, lyophilisation allows the material to be stored at room temperature, making it easier and more cost-effective to transport. However, the lyophilisation process itself can be time-consuming and costly, which is why many companies are looking for ways to improve its efficiency to reduce costs.

One of the most important factors in lyophilisation is the length of the lyo cycle. The longer the cycle, the longer the product takes to be produced, and the more it costs. One of the main services offered by Biopharma Group is the optimisation of lyophilisation cycle recipes, which helps reduce the costs associated with production.

The following case study is quite characteristic. Biopharma Group worked with a company producing oncological products by using an old, legacy 96-hour cycle. This company in the US, used to produce their oncological products in 2R glass vials. The cost for one vial was estimated $1,000. Since the batch size was 5,000 vials, the entire batch costed $5,000,000. Around 4% of the vials were rejected (equivalent to $200,000!). With this as a starting point, Biopharma Group performed the following R&D activities:

•  Initial desktop study to evaluate the current available data related to the product and process.

• Thermal characterisation by freeze drying microscopy (Lyostat analysis) and DTA/electrical impedance analysis (Lyotherm analysis).

• A series of developmental cycles with associated post process analyses to fine tune the process parameters, followed by a confirmatory cycle to evaluate the process repeatability.

• Once the nominal lyo cycle protocol was designed, the process was then stressed by varying its parameters to identify the process design space.

After cycle development, the length of the process was reduced to 46 hours and the rejection was reduced to 0.9%. This meant that for each cycle $155,000 was saved! Basically, they were able to recover all contract R&D expenses in just one cycle. Additionally, the company was able to fit more cycles in a year with an increase of 108% in Productivity.

Investing in contract R&D may seem like a daunting task, but the benefits speak for themselves. In working with Biopharma Group, companies can save time and money by reducing the length of the lyophilisation cycle. Here’s some examples of data from a few of Biopharma Group’s 2024 projects: an average of 40% reduction in cycle time with a reduction in the number of rejected vials, an average increase of 65% in productivity, and limiting the use of the cold chain with an average of 80% reduction in storage costs. The return on investment can be substantial, with companies like the one mentioned in this article recovering all expenses for contract R&D in just one production cycle. With Biopharma Group expertise in lyophilisation cycle optimisation, as well as their variety of services for the biotech and pharma industries, companies can bring their products to market faster and more efficiently. The cost savings in the production of oncological products can be substantial, making it a no-brainer for decision makers in the pharmaceutical industry.

Biopharma Group is a leading provider of services for the biotech and pharma industries, with a key focus on lyophilisation. In particular, consultancy, training courses and contract R&D for liquid and lyophilised products, including formulation and process development for lyophilisation and spray drying.

Biopharma Group also provide contract manufacturing for these products in both non-GMP and GMP formats, such as vials, trays etc. Partnering with a CDMO such as Biopharma Group offers expertise in R&D and GMP manufacturing to provide high quality scientific support and product supply, whilst avoiding the upfront complexity and cost of building in-house capability at early stages.

If you are passionate about improving efficiency and quality, reach out to Biopharma Group’s specialists via www.biopharmagroupcdmo.com