Lyophilisation stérile / Sterile lyophilization traitement d’air. Des limites de pression cation et de lyophilisation jusqu’à la opéré la rénovation de trois de ses 13 sont établies pour chaque zone, asso- fabrication des flacons lyophilisés et du lyophilsateurs : Lyomax 1 et 2 de 17 ciées à un système d’alarme sonore et produit fini, documenté et caractérisé – m2 et SMH 3120 de 31 m2, sa plus lumineux. « Nous travaillons en étroite et permet à nos clients de se différencier grande capacité. Ceci afin d’augmen- collaboration et en synergie avec les sur leur propre marché. » Rappelons ter leurs performances et réduire leur autres sites de Synerlab, notamment que fin 2018, le site Lyofal avait reçu consommation électrique. Lyofal, rappelle Noelia Garfia Garcia, l’accord de l’ANSM pour l’extension de directrice commerciale d’Alcalá Farma. son champ d’autorisation d’ouverture Des coûts fixes de plus Notre proposition de valeur intégrée pour la production de cytotoxiques en plus élevés entre nos deux sites spécialisés dans sous forme lyophilisée stérile injectable, la lyophilisation est unique – allant de destinés aux médicaments à usages « Les coûts fixes inhérents à la produc- l’optimisation des processus de fabri- humain et expérimental. En 2020, il a tion de médicaments stériles sont déjà Le nouvel équipement de Synerlab Alcalá va permettre d’atteindre une capacité annuelle totale de 13 millions de flacons par an à partir de 2021. Synerlab Alcalá’s new equipment will enable to reach an annual total capacity of 13 million vials per yer as of 2021. of lyophilized vials and finished products are already very high,” Sébastien Poncet medicinal products, and globally on all that are documented and characterized - reminds us. He explains: “Only the water the market for sterile products, which are this is what allows our clients to stand out for injection system - the water used for capital-intensive markets, contract manu- on their respective markets.” Let us recall injectable preparations - costs facturing becomes relevant for sharing that at the end of 2018, Lyofal’s site had €10 million.” According to him, the investments. Indeed, if a pharmaceutical received ANSM’s approval to expand the ongoing revision ofthe EU GMP Annex company wants to launch its own line of scope of its authorization and initiate the 1 on Good Manufacturing Practices for sterile lyophilized drugs, it requires at least production of sterile, injectable lyophilized Sterile Medicinal Products to be enforced €30 million, which is difficult to justify cytotoxic products for human and investi- as of 2023 will not only require new from an economic point of view in the gational use. In 2020, the plan renovated investments on the side of pharmaceutical case of annual productions amounting to a 3 of his 13 freeze dryers : Lyomax 1 and 2 companies but also their bringing into few million units. ” 17 sq meters and SMH 3120 31 sq meters, compliance. This will also significantly their larger capacity. This to increase their impact fixed production and analytical performance and reduce their electricity costs. Hence, sufficiently large production consumption. volumes will be necessary in order to amortize such fixed costs. “The notion Ever-higher fixed costs of critical size will become meaningful for all the operators lacking the necessary “The inherent costs related to the pro- capabilities to dilute these costs, he says. duction of sterile medicinal products This is why, on the market for lyophilized 38The Pharmaceutical Post 02 / Juin - 2020