By Sofrigam S.A
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Sofrigam surveys biomedicine logistics
Rueil-Malmaison, France: – Temperature-controlled logistics and pharmaceutical cold chain specialist Sofrigam SA has studied the future development of biomedicines, pointing to emerging solutions for their transport and storage.
The rapid rise of biomedicines that incorporate ‘live’ or active organisms has increased demands for temperature-controlled logistics previously required mainly for heat-sensitive vaccines and insulins.
Sofrigam’s latest website blog seeks to answer why biomedicines need to be stored at specific temperatures and whether any new solutions are emerging to help with their transportation.
Biomedicines: targeted treatments
Over the last decade, the world of healthcare has witnessed a significant transformation in the development of medicines with the rise of biotechnologies that use living organisms (tissues, cells, proteins) or parts of them (genes, enzymes) to develop medicines. In drawing on a biological source, such as a raw material of the active substance that they contain, they differ from conventional ‘chemical drugs’ that still account for the majority of pharmaceutical industry products.
Antibiotics, insulins, blood-derived medicines, vaccines and growth factors are all biomedicines that are either extracted directly from living things or derived from genetic intervention. Biomedicines are increasingly specific, targeted treatments, opening the window to genuinely personalized medicine that targets extremely precise pathological mechanisms in the diseased organism.
Some 80% of newly developed molecules are dedicated to the chronic and degenerative diseases that are the greatest cause of mortality in the world, according to the 2013 WHO publication: Non-communicable diseases: facts and figures.
“This is why it is necessary to innovate and create personalized treatments, to best respond to the needs of patients,” says Sofrigam.
Demanding storage standards
The production of biomedicines and biosimilars (biological medicines whose patent has fallen into the public domain) is complex because it relies on living cells or organisms. This is why they often need to be continually stored at a given temperature, complying with standards defined by the manufacturer in the Marketing Authorization (MA) dossier, an authentic identity document for the medicine. The MA dossier attests to the quality, safety, efficacy and reproducibility of the medicine, which has previously been subjected to preclinical and clinical tests – a process that lengthens the typical development period of such medicines to five years or more.
When marketing authorization is given by ANSM (National Health Products Safety Agency) or the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), the storage and distribution of these sensitive medicines must be in strict accordance with the procedure described in the MA dossier and guided by Good Distribution Practices of medicinal products for human use (GDP).
Room temperature solutions
“It should be noted that not all biomedicines need to be stored in the refrigerator. Each medicine is different and must be stored and transported in a specific way, therefore it is necessary to consult the MA dossier which specifies the storage conditions for the medicine,” Sofrigam points out.
“Certain insulins for example, must be stored in the refrigerator if they have never been opened but can then be stored at room temperature for up to a month. Conversely, it is extremely important not to freeze them as they lose their effectiveness. All heat-sensitive medicines must be stored in the refrigerator, they are far more sensitive to ice than to exposure over +8°C,” the company comments.
Sofrigam reports that some promising methods are currently being developed to store initially heat-sensitive medicines at room temperature, especially in the case of certain vaccines.
“The vaccines are, for the most part, viral vectors, this means that the structure of the viral components of vaccines break down after a few hours at room temperature. The heat destroys their integrity and they become ineffective. Some researchers have had the idea of adding additives so that they remain stable, even at room temperature,” says Sofrigam.
The company rates this discovery as ‘promising’, given the problems in developing countries where the challenge of providing cold storage due to lack of material resources is a principal cause of low vaccination rates.
The big players in the pharmaceutical industry are turning the corner in biotechnology: one out of every two new medicines is made up of active substances originating from cell cultures rather than chemical molecules. In addition to scientific progress, technology plays a significant role in the development of new treatments. The challenges of storing and transporting these medicines at controlled temperatures are therefore essential.
French-based Sofrigam S.A. designs and manufactures cool chain pharmaceutical shipping solutions and insulated boxes for the life sciences industries as well as for distribution and logistics companies.
The company was founded in 1979 by an industrial pharmacist and initially developed eutectic painkillers before specializing in the design and manufacture of insulated and refrigerated packaging, including pre-qualified insulated shipping and temperature management solutions. The company is headquartered in Ile-de-France with a production site at Arras.
Sofrigam offer solutions for the cold chain logistic problems experienced by the pharmaceutical industry. It offers a range of standard and made-to-measure thermal packaging products as well as customized services designed to achieve secure, cost effective and ecological cold chain logistics.
Sofrigam has become one of Europe’s leading cold chain specialists, sharing its expertise via seminars, publications and R&D collaborations. It also offers customized products and services designed to achieve cold logistics that are secure, cost-effective and comprehensively compliant.
Sofrigam partners with Ater Métrologie, a French-based ISTA and ISO 9001 certified laboratory that specializes in testing, validating and pre-qualifying temperature-controlled packaging and cooling systems. The laboratory carries out some 2,000 tests each year