In an interview with in-PharmaTechnologist.com Vincent Santa Maria, President, Bilcare GCS set out some of the reasons behind the expansion.
Santa Maria said that the primary motivations had been: “The increasing outsourcing trend by large Pharma combined with increasing regulatory pressures driving an increase in number and size of clinical trials and globalization of clinical trials.”
“Clinical trials have grown increasingly global, larger and more complex. Government regulations are progressively more stringent, requiring more studies with larger patient populations. To register such large numbers of patients in minimal time and in competition with other companies often requires population sets that span multiple countries.
Santa Maria added that: “The healthcare industry is growing rapidly due to greater life expectancy leading to greater incidence of chronic and degenerative diseases, advances in medical technology that continue to improve the survival rate of severely ill patients, who will then need extensive therapy, care and new technologies that enable the identification and treatment of conditions not previously treatable.
“In order to maximize profits and maintain comparative positions, pharmaceutical and biotech companies must continue to identify and test new patentable products that can eventually be brought to market.”
Expansion of Phase III Packaging Capabilities
Regarding the specific additions to Bilcare’s offering, Santa Maria explained that the firm has: “reconfigured its [Kalish] bottling line and has improved its overall compliance posture by re-executing key validation packages on each of the bottling lines' individual components and by successfully executing a more robust performance qualification.”
He confirmed that a major part of the expansion is the integration of a Pentpack CT1200L EAS unit dose blister packaging machine, which she said: “epitomizes the flexibility required to excel in the demanding and dynamic realm of clinical supplies.”
“With a single machine, Bilcare is able to run almost any type of thermo formed film as well as cold form. Whether we choose to operate the machine with the manual feed table that is capable of filling up to four different products simultaneously, or we choose to engage the powerful Fleximation Trialpack PC controller and automatically dose two different products in any desired configuration.”
Santa Maria highlighted the unit’s ability to share tooling with Bilcare’s existing Klockner EAS machine and that it can print on either the inside or the outside of the blister packages, which in some cases can negate the need for timely and costly carding operations, as key advantages offered by the apparatus.
He maintained however that: “Some of the most tangible benefits that this machine provides are quality related, such as the full colour vision systems that are integrated with the Trialpack Designer II… software that provide a level of comfort and safety by ensuring a correct and complete filling operation.
“Another valuable benefit is the automatic pinhole detection and rejection system which virtually eliminates the risk of undetected breaches in the integrity of the blister cavity which are so critical for the performance of sensitive drug products.
Santa Maria concluded that as a result of its expanded offering: “Bilcare GCS is a one-stop shop for [customers], providing end-to-end clinical trial services - from formulation development and manufacturing, analytical, packaging and labeling, to storage and distribution, and IVRS. We also offer strategic in-sourcing to key customers.”