Q1 Scientific

Q1 Scientific is a pioneer in the Irish industry and a world leader in the provision of outsourced environmentally-controlled stability storage. Q1 Scientific is revolutionising how pharmaceutical companies store their product, and helping to improve the speed it takes for drugs to reach the marketplace.

The service saves pharmaceutical companies the expense of building and monitoring their own storage chambers. In doing so, Q1 Scientific becomes a seamless part of their client’s organisations and enables their clients to focus further on their own particular areas of expertise and research & development.

Q1 Scientific clients are mainly large blue-chip multinational pharmaceutical companies, predominantly Irish based firms including both indigenous businesses and well-known multinationals. In addition, the company also stores samples from firms in the UK, Norway, Germany and the US, who manufacture products that are destined for the European market.

Ireland is recognised as a global centre of excellence for life sciences, and Q1 Scientific is very much part of that process. Q1 Scientific offers their clients a secure cloud-based monitoring solution giving them real-time visibility and enabling clients to log in remotely 24/7. Whether clients are storing 2 or 2 million samples, Q1 Scientific offers the same customer-focused service, which allows clients unprecedented access and control of samples.

Stability Testing Requirements

Within the pharmaceutical industry, the testing of stability samples is critical to ensure products maintain their integrity. These samples are tested to ICH conditions, which mimic the climatic zones of countries, as below:

Q1 Scientific caters for all climatic zones, ranging from -80°C to 40°C / 75%RH. Long-term testing is generally carried out at 25°C/60%RH, for a minimum of 12 months, while accelerated testing is carried out at 40°C/75%RH for a minimum of 6 months.

Our GMP facility contains rooms and chambers that have been mapped and validated for long, and short-term shelf life studies under various temperature and humidity requirements. This includes intermediate testing and accelerated testing per ICH Q1A (R2).

Q1 Scientific Services

Along with providing controlled-environmental storage, Q1 Scientific has a range of additional services offered to clients.

Complete Sample Management Service

Q1 Scientific offers a complete stability sample management service. The Q1 Scientific QMS is set up to manage stability samples from initial protocol development, through to defining pull points, and delivering samples to the laboratory for analysis.

Q1 Scientific clients can access and manage all their stability study data remotely as if the samples were being stored on-site. Each Q1 Scientific client has their own secure website portal through which they can access documentation for their own study samples. In addition, each client has a dedicated Study Calendar which details all study events, including ‘pull points’, duration and any special actions related to the stability study, providing clients with full visibility of their samples.

Disaster Recovery

Q1 Scientific can provide a primary or contingency storage solution, with the option of disaster recovery storage available if required. We have a disaster recovery procedure in place to cover any emergency transfer of samples from clients- from individual batches to entire chambers. Clients can be assured that should one of their own stability chambers go down, Q1 Scientific can transfer the affected samples to our facility, to avoid significant interruption to stability studies.

Thermal Cycling

Thermal Cycling gives an indication as to how a product will react to adverse conditions, potentially encountered during transportation. The range encountered during transportation may differ from that specified for long term storage. To understand the effect these excursions may have on a product, Thermal Cycling studies are completed.

Q1 Scientific caters to specific client requirements for freeze thaw studies. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipment and subsequent use (ICH Q1 A 2.1.7). Q1 Scientific temperature-controlled transport ensures maintenance of product quality between our facility and the client site location.

Photostability

For companies developing and manufacturing drugs, a robust photostability testing process is essential to ensure product quality and regulatory compliance. The intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrate that, as appropriate, light exposure does not result in unacceptable change. Q1 Scientific carries out photo stability studies to client specifications.

BioBanking

Q1 Scientific can provide long-term controlled storage for biobank samples in a secure monitored location. Complete confidentiality is assured with a simple sample retrieval process and temperature-controlled transport. Q1 Scientific provide an independent storage service for study samples, research materials or long-term retain storage.