Biological Medicines and Special Medicinal Products, Part 1
Why Proper Temperature Control Is Imperative Practice
Life Sciences
The Article This Is The First From the Three of the Series, From on the White Paper With Title: Biologic Medications and the Specialty Pharmacy: A Practical Reference Guide for Ensuring Efficacy and Patient Safety through Proper Cold Chain Management. These articles highlight the challenges, risks and best practices for maintaining appropriate temperatures for biological medicinal products, while under the care of pharmaceutical companies and their partners in their supply chain.
Biological Medicines and Special Medicinal Products
To achieve better results in patients from complex diseases, manufacturers produce a wide range of biological medicinal products or special medicines. These drugs cure everything, from autoimmune diseases, dermatitis and hemophilia, to cancer, multiple sclerosis and diabetes.
Unlike traditional small molecule drugs that are chemically synthesized, organics are products of a large molecule, manufactured through more complex biotechnology structural processes. Due to their components and structure, biological medicinal products are extremely sensitive to heat and cooling which are outside the acceptable range determined by manufacturers.
Manufacturers of pharmaceutical products, providers of supply services, distributors of specialised products, up to specialised pharmacies play a crucial role in ensuring proper temperature management of these medicines. Actually, manufacturers of special pharmacies are required to follow the GNP regulatory guidelines (EU GDP) the EU and the US for the handling of, storage and distribution of temperature-sensitive biological medicines, which may require additional special handling due to the sensitive nature and potentially critical supply chain.
Proper temperature control and monitoring is imperative
Strict regulatory , which manufacturers of medicinal products must follow, may be more complicated for special medicines, because any kind of out-of-temperature limit could lead to harmful modification of the structure of a biological medicine, or even possible degradation. This not only affects the effectiveness of, but most importantly, temperature changes could seriously affect the prescribed treatment and patient safety.
Requirements for biological medicines, include strict temperature control and continuous monitoring strategies, to be applied, from the moment biological medicines are manufactured until they are distributed, or within the pharmacy, or when sent directly to a patient or doctor.
For example, think about what a pharmaceutical manufacturer needs to do to ensure proper temperature control on a shipment from its production facility to its distribution chain with multiple pharmacy delivery chains. All pharmacies need to be aware of the potential environmental challenges and shipping conditions of the product – and prepare the product correctly – as it is sent via multiple transfers and transfers to different regions and temperature zones. Excessive temperature changes or loss of control during the shipping cycle could significantly affect the quality of the product and its effectiveness.
The manufacturer of medicines assumes responsibility throughout the supply chain
Pharmaceutical manufacturers need to fully understand the requirements and stability data, as well as the challenges, the risks and best practices of industry, for temperature control and monitoring. They need to accurately understand the specific guidelines for complying with applicable government and state regulations. Finally, need to know how to protect the integrity and efficacy of the product, while offering the maximum to patient safety.
Full and proper compliance requires awareness, in-depth education and training. It also requires suitable equipment and supplies, together with specific standard operating procedures (Sop) for the refrigeration and transport of these products.
This Case: The impact of thermal packaging and transport routes
Thermal packaging and shipping routes are two critical areas where temperature deviations could be made. Depending on the specified path, the carrier most likely receives the shipment by truck to the manufacturers' distribution centre, let's say in the state of Illinois and, Then, delivers it to the nearest airport for air or land transport. The last leg of the trip, say, is to Florida at the specialized pharmacy., which is again carried out by road transport.
On the way, there may be differences in geography, ambient temperatures and humidity. Temperatures within the transport unit and storage areas of each carrier may also vary, as could be different from transport procedures and delays in delivery times.
In some cases, thermal packaging is used. The commercially available thermal packaging is designed to maintain a specific internal temperature range for shipments. However, the reliability of the packaging during shipment;, Thus, integrity of products, can only be ensured if the designed packaging, with materials such as gel packs and cargo substrate, configured correctly before the product is sent.
Packaging Reliability
If there are temperature deviations, caused by any of the above environmental or transport conditions, then the reliability of the packaging may be adversely affected. If at any time during the shipping process, the temperature of the biological product is outside the acceptable range, product quality and efficacy can be put at risk.
No proper temperature controls and continuous monitoring, these temperature deviations, often go unnoticed, which would present significant risks not only to the pharmacy, but most importantly, for patients who will eventually use the products.
Source: Sensitech Inc.,
For more comprehensive information, download the full white paper: Biologic Medications and the Specialty Pharmacy: A Practical Reference Guide for Ensuring Efficacy and Patient Safety through Proper Cold Chain Management.