By Sofrigam S.A
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Sofrigam identifies strategic cold-chain logistics challenges
Rueil Malmaison, France: – Pharmaceutical cold chain specialist Sofrigam SA says temperature-controlled logistics now poses ‘a real challenge’ for healthcare companies, pointing to increasing financial, regulatory, technical and environmental complexities.
A new Sofrigam website article analyzes data from the Evaluate Pharma 2016 Report to highlight their impact on a range of strategic cold chain logistics issues, including increasing reliance on heat-sensitive products, more rigorous regulations: the technical challenges of temperature-controlled transport and overall impact on logistic costs.
The rise of biotechs
The 2000s have been marked by a period of global economic crisis and the emergence of generic laboratories, both impacting on the profitability of ‘conventional’ pharmaceuticals.
“Consequently, pharmaceutical laboratories have been forced to review their strategy and from this point forward focus their research on healthcare products stemming from biotechnologies,” says Sofrigam.
Although patents have become more profitable and longer lasting, their development has also become far more expensive.
“The pharmaceutical companies are therefore developing innovative treatments stemming from biotechs, which respond to a growing demand for illnesses such as cancer or diabetes,” Sofrigam points out.
The ‘hidden cost’ of biotech medicines, originating from living cells, is that they are extremely sensitive to variations in temperature, with very little tolerance to fluctuations.
Sofrigam points to an estimated 45% rise in the number of temperature sensitive healthcare products between 2011 and 2017, to the point that approximately half the medicines now on the market now require cold chain or cool chain storage and shipping.
Marie Boned, Quality Distribution Manager & Pharmacist within the Septodont laboratory, is an expert on regulatory issues. She points to a significant tightening in regulations regarding cold chain logistics of healthcare products:
“The publication in 2012 of the new GDP (Good Distribution Practice) for medicines is not without consequences for temperature-controlled logistics,” said Ms. Boned.
“It requires the implementation of devices ensuring the temperature control of healthcare products and medicines stored at +15/+25°C. The logistics of heat-sensitive products is becoming a real headache for laboratories, which combine the financial-security-regulatory aspect with increasingly larger volumes,” she comments.
“Simultaneously, laboratories are subject to the ISO 14001 standard, based on continuous improvement of environmental efficiency. The laboratory must act to minimize the damaging effects of its activities on the environment,” Marie Boned adds.
Growth with new constraints
The development of biotechs, combined with the increased prevalence of illnesses requiring heat-sensitive treatments has resulted in a clear market volume increase in demand for cold chain logistics packaging and services for medicines and other healthcare products. At the same time, the increasing sensitivity of more sophisticated products combined with tightening regulations and environmental pressures are increasing the cost of temperature-controlled shipping and storage.
The market for temperature-controlled logistics for healthcare products could reach USD 13 billion in 2019, a 40% increase over 2013, resulting in an average of a 14% cost increase in cold chain provision expenditure for healthcare companies, compared with current levels.
“There is growing awareness among laboratories that transporting temperature-controlled products requires specific equipment, such as insulated shipping packaging solutions, temperature monitoring and recording, cold chambers and refrigerated vehicles, which makes the logistics increasingly expensive, with greater risks and growing potential real environmental impacts,” says Sofrigam.
“In fact, the implementation of cold chain logistics is far from simple. It is necessary to simultaneously bring together risk management, cost control, patient safety and regulatory compliance,” the company concludes.
Sofrigam suggests two main routes to reconciling the needs to minimize logistical costs while maintaining temperature security. One approach is adoption of a ‘circular economy’ approach to air and land transport in which the traditional ‘make, use, dispose’ model is replaced by one that keeps resources in use for as long as possible, extracting maximum value from them, before recovering and regenerating materials at the end of service life.
The other approach is to make greater use of sea transport, trading speed against cost. Sofrigam will explore both approaches in further articles over the coming months.
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.