Doubling capacity
In order to meet the increasing need for sterile freeze-dried injections for vaccines and generics Lyofal, located in Salon-de-Provence, France, is doubling the capacity of its drugs lyophilisation plant.
Laboratoires Lyopharm, a division of Lyofal dedicated to the pharmaceutical industry, will initially build a 1,000 – 1,500m2 unit for the production of freeze-dried parenterals in clinical lots, to be followed by a unit for the production of industrial quantities. The unit is likely to increase the personnel by 25% to 40 in total.
Further down the line, the company plans to build another unit by 2004/05, according to Jean-Luc Allemand, chairman and founder. Currently, there are plans to register a new file for this application in order to meet the ever more demanding requirements of the French Drug Agency and the US FDA.
'We strongly believe that outsourcing will grow with these new requirements. Today, and even more so tomorrow, quality assurance, quality control and compliance with procedures remain the main priorities in negotiations as manufacturing standards continue to progress.'
Lyofal already has a production area of 2,500m2, including 1,000m2 of cleanrooms – classed D, and C – including 60m2 under laminar flow. It develops and manufactures new products, carries out pilot testing, prepares substances for lyophilisation, carries out industrial production in both sterile and non-sterile environments, and does post lyophilisation operations such as desiccation or packaging.