Biotech Boom Drives Lyophilisation

Biological shift

A growing biotechnology pipeline is fuelling the demand for lyophilisation technologies, and drug companies are looking to partner with contract manufacturing organisations (CMOs) which can assist them with lyophilising their increasing biological product range.

In a recent interview with Pharma IQ, Tim Nicholls, director at eXmoor pharma concepts said: "All major companies are driving their growth through biotechnology derived products. It has taken a considerable time for biopharmaceuticals to come to fruition, the increase in current pipeline will continue the requirement for lyophilisation for some time to come."

According to RNCOS new research report Global Protein Therapeutics Market Analysis: “The number of protein based pharmaceuticals reaching the marketplace has exponentially increased over the past few years. With increasing demand for innovative protein therapeutics each year, existing as well as new players are making huge investment into this market.”

However, many biological drugs are unstable in liquid form and would not be viable, if it were not for some form drying method to make storage easier at room temperature. It is therefore essential for companies producing biological drugs to work with companies that can offer efficient drying services.

Advantages of Lyophilisation

Lyophilisation, or as it is commonly known freeze drying, is often used by biotech companies to stabilise and increase the shelf life of vaccines, antibodies and other biological materials.  Lyophilisation’s main advantage over conventional drying methods is that it enables manufacturers to freeze dry drugs without damaging their internal structure.

Freeze-drying a protein or a peptide-based drug keeps it in a stable form, until it is reconstituted with the addition of an appropriate diluent, just prior to administration. Compared with crystallised products, the speed of rehydration makes lyophilisation one of the quickest routes to developing a biological product for administration to patients. Lyophilisation products are produced in a sterile environment into final product containers/vials, so they can be dispensed with a high degree of accuracy. Reduced water percentage of the product, also results in cheaper storage and transportation costs.

Cost vs. capacity

So why are manufacturers seeking lyophilisation services externally? Despite all of its advantages, lyophilisation remains a relatively complex and expensive form of drying. The initial outlay for equipment is about 2-3 times higher than conventional drying methods and the running costs are also higher. The drying cycle is also longer approximately 24 hours.

Demand for lyophilisation services is expected to rise, and as such contract manufacturing organisations have responded by investing in lyophilisation equipment or acquiring these services through mergers and acquisitions.
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Just two examples of activity this year include, Recipharm's European manufacturing network acquiring Wasserburger Arzneimittelwerk to add large -scale lyophilisation to its offerings. Canadian contract development and manufacturing organisation (CDMO) Therapure Biopharma has also recently added commercial-scale lyophilisation capacity at its facility Mississauga, Ontario in direct response to the needs of its customers.

Thomas Wellner CEO Therapure Biopharma, explained to Outsourcing-pharma that further expansion of its lyophilisation capacity was likely: “We are expecting to fill our current lyophilisation by [capacity] 2012 and we have contracts which will require adding a 2nd and 3rd lyophiliser.”

Many high-value biotech drugs could not be manufactured without lyophilisation, and the benefits continue to be recognised by the industry. "If you look to all major companies they have small and large molecules which require lyophilisation technologies," said Nicholls. Drug manufacturers and contract manufacturing organisations are both calling for cost-effective ways for large scale commercial usage. As a result, we will see investment in the advancement of freeze-drying technologies and monitoring equipment to increase automation and reduced cycle times.