By doubling its current capacity, the new Birka BioStorage site will achieve the target for phase II with 3000 sqm of storage space. In addition, the new space will include new solutions, such as clinical kitting, stability testing, product re-packaging and analytical services.
By combining an accumulated ten years of knowledge, skills, and experience, Birka BioStorage has been developing a globally recognised model, for the handling of products and samples according to stringently implemented GMP and GDP procedures. This model allows a new level of sample availability and relocation flexibility, where bottlenecks such as shipping temperatures and transport routes are minimised.
The most beneficial improvement is guaranteeing the Just-In-Time and Place (JITP) access to needed samples. As a result, Birka’s customers have been able to build in solid and cost-effective project logistic catalysts. Thus, the benefit of parameters such as increasing of batch manufacturing size, conducting several R&D studies in parallel and managing a sustainable logistics chain, will fill in the gap.
Developing to match future challenges
The outsourcing trend continues – The higher requirements of compliance to regulatory guidelines on sample storage and transport has been pushing many drug developing companies to select the outsourcing option, as the number one path, to obtain standardised set of solutions for the services.
In addition, the increasing expectations by the authorities over storage and distribution of clinical products, to guarantee the quality and potency of drug products, as well as the integrity and safety of reference samples, is driving for the outsourcing of such services to the expert partner. Birka’s model, to cover the total need of the customers’ sample logistics, will fill in the gap.
In-house analytical services – As per today, samples are generally risked during shipments to analytical service providers, added to, the shipping cost, the risk of fluctuation, counterfeit, and discontinuation in the monitoring of shipping conditions. A time-consuming step needs to be avoided. The new model includes solutions for integrated on-top analytical programs during the storage period, as part of the customer´s development or stability studies, Birka’s new next-door unit for sampling and analytical services, will fill in the gap.
“The new building will add a total of 1400 sqm of storage space to the current capacity. This area will be harmonised between ambient, ultra-low temperature, freezer, and cold walk-in rooms. In addition, a number of modern large scale walk-in stability chambers will be installed”, says Hussein Ismail, CEO of Birka BioStorage.
“We are committed to continue developing Birka’s concept to match the future challenges of drug development. We are convinced that the Medicon Valley region offers the best location for the global central lab to come”.