Category: general

How do I protect my cold chain required pharmaceuticals against unauthorized access of third parties?

Interesting post? Share it on:

With Nelumbox the protection of your cold chain required pharmaceuticals becomes easy. With the help of the inbuild RFID-lock you can protect your pharmaceuticals against infants or deny access for carriers and unauthorized third parties.

Nelumbox has a digital locking mechanism, which restricts access to the content inside Nelumbox via an RFID-System.  With the help of an individual access hierarchy, certain functions, like manually changing the predefined temperature range, can only be granted to chosen people by handing out preinstalled RFID-tokens. Furthermore, every opening of or change to Nelumbox is tracked and documented by our intelligent software.

This way you can not only keep track of:

  • Inner temperature,
  • Outer temperature,
  • Humidity,

but also:

  • The exact geo localisation,
  • Opening and closing
  • And any adjustment of Nelumbox.

All of this you can find, export and archive in your password-protected Nelumbox Dashboard.

For your RFID-transponders you can buy our offered RFID-cards and tokens, or even use your own existing RFID-transponders.

In a future article you will get to know more about Nelumbox Dashboard, what possibilities it offers concerning documentation, assigning access rights and how you can benefit from all the other features the Dashboard has to offer.

Interesting post? Share it on:
Active cooling becomes more important in cold chain logistics

What is the runtime of Nelumbox in the cold chain required temperature ranges 2 – 8°C / 35,6°F – 46,4°F and 15 – 25°C / 59°F – 77°F?

Interesting post? Share it on:

Depending on several external factors, such as the ambient temperature, Nelumbox can reliably cool between 6 and up to 24 hours on one charge.

Essentially Nelumbox has a potential infinite runtime. Because of its conventional power connection, Nelumbox can run stationary as long as it is connected to any external power source. In mobile use, swapping the two exchangeable batteries makes it possible to also extend the runtime for good. On top of that, carrying a base station for the batteries enables external charging of the batteries in the hotel room, while carrying the Nelumbox with you throughout the day. In addition, Nelumbox can also be charged through a cigarette lighter plug in your car or any other vehicle equipped with it.


These are the most impactful factors influencing the runtime of Nelumbox:

  • Nelumbox runtime is dependent on the outside temperature. While the runtime on room temperature (18°C – 23°C / 64,4°F – 77°F) is up to 24 hours at 2-8°C (36-46°F) inner temperature, the runtime halves at a temperature of 35°C / 95°F and more.
  • When the outside temperature falls below 0°C / 32°F Nelumbox must heat. At 0°C the runtime at 2-8°C comes close to 30 hours.
  • For a detailed ISTA 7D/E profile, please contact us at keepcool@tec4med.com

 

Here are some handy tricks to easily extend the runtime of Nelumbox:

  • Before transporting and while cooling down to the desired temperature range, Nelumbox should be kept connected to the grid. Reaching the desired temperature of 2 – 8°C / 35,6°F – 46,4°F starting from room temperature needs a lot of energy, therefore cooling down on battery should be avoided.
  • Extreme variations of temperature while Nelumbox is running on battery should be avoided. The compensation of temperature change, especially from cold to hot temperatures needs a lot of energy.
  • If you must open Nelumbox while transporting, make sure it is standing up, so you can open the door vertically to the top. This way the cold air is not “falling out” of the cold chamber and the energy costs for cooling are reduced significantly.
  • The ventilation and exhaust air must have enough space to work properly, otherwise the cost of energy will rise considerably. 5 – 10cm / 2 – 4 Inches should be enough.

 

Here you will find the next FAQ blog article.

If you have any questions, please do not hesitate and send us an email: info@tec4med.com

 

Interesting post? Share it on:
Active cooling becomes more important in cold chain logistics

Does Nelumbox cover all relevant temperatures for cold chain required pharmaceuticals?

Interesting post? Share it on:

Yes, Nelumbox covers all common and for cold chain required pharmaceuticals relevant temperatures, such as 2 – 8°C / 35,6°F – 46,4°F and 15 – 25°C / 59°F – 77°F, but Nelumbox is capable of more:

Nelumbox covers the temperature ranges for most cold chain relevant concerns: 2 – 8°C / 35,6°F – 46,4°F and 15 – 25°C / 59°F – 77°F, but is not limited to cooling. Nelumbox is able to heat as well. This unique advantage is most useful in times the outer temperature drops far below 0°C / 32°F, in which case Nelumbox will heat energy efficiently and keep the temperature inside between the required 2 – 8°C / 35,6°F – 46,4°F or more. This way we can assure that your valuable content is save even if you are travelling to Germany, Siberia, North- or South Pole.

Because of this technology Nelumbox is capable of incubating at a temperature of 37°C / 98,6°F and can even heat up to a maximum of 55°C / 131°F. Furthermore, Nelumbox can be set on a custom temperature range from 2°C – 55°C / 35,6°F – 131°F. If held stationary even smallest temperature ranges are possible.

Here you will find the next FAQ blog article.

If you have any questions, please do not hesitate and send us an email: info@tec4med.com

Interesting post? Share it on:

The great Nelumbox FAQ

Interesting post? Share it on:

Lately, every day we receive calls and emails asking us specific questions concerning Nelumbox. Therefore we are going to collect all these great questions and start a series of blog articles. During the upcoming weeks you can expect exciting articles on multiple aspects of Nelumbox.

If you cannot wait that long, please do not hesitate to contact us.
Feel free to ask your questions and send us an email:
info@tec4med.com.

Who knows, maybe your question will find its way into our series of blog posts.

These are the FAQ posts so far:

1. Does the Nelumbox cover all relevant temperatures for cold chain required pharmaceuticals?

Yes, the Nelumbox covers all common and relevant temperatures for cold chain required pharmaceuticals, such as 2 – 8°C and 15 – 25°C. But, Nelumbox is capable of more…


2. What is the runtime of Nelumbox in the cold chain required temperature ranges 2 – 8°C / 35,6°F – 46,4°F and 15 – 25°C / 59°F – 77°F?

Depending on several external factors, such as the ambient temperature, Nelumbox can reliably cool between 6 and up to 24 hours on one charge.
Interesting post? Share it on:
cold chain monitoring pharma logistics, Überwachung der Kühlkette Pharmalogistik

Cold Chain Monitoring in Pharma Logistics

Interesting post? Share it on:

By 2020, the global cold chain monitoring and tracking market is expected to reach $ 426 billion. Back in 2015 it was only $ 148 billion. The most lucrative segment is the healthcare sector. The Cold Chain Sourcebook by Pharmaceutical Commerce projects that by 2021, pharma cold-chain logistics will be worth $ 16.6 billion. Cold chain monitoring and tracking refers to controlling devices equipped with sensors that ensure the transportation of temperature-sensitive medication at a given temperature-range.

Why is cold chain monitoring and tracking a growing business?

There are three major drivers behind the growing demand for cold chain monitoring and tracking in pharmaceutical cold chain logistics. The first being the transition towards bio-engineered, temperature-sensitive products. The second being tightening regulations for pharma shipments and the last being the growing internationalization of the pharmaceutical supply chain.

  • The turn towards biologically-based products:

The number of bioengineered drugs is steadily increasingBy 2020, 27 of the 50 top selling drugs will be temperature-sensitive biologics, requiring cold chain storage and handling between 2-8 °C. Bioengineered drugs are on the rise due to their high specificity and complexity that matches the natural biological processes in the human body and therefore lowers the risk of adverse effects.

Biologically-based medication is produced in lengthy and cost-intensive biotechnological processes in living, genetically modified organisms or cells. That makes these drugs cost-intensive in their production and expensive for buyers. Bioengineered drugs range between several hundred to several thousand dollars for a set of syringes or pens.

The gained bioengineered protein drugs are highly sensitive towards temperature excursions. If the temperature exceeds or falls below a certain temperature range, the medication´s delicate tertiary structure is being destroyed and the drug gets ineffective. This is why biologically-based drugs demand for special cold chain packaging in logistics procedures, such as insulated packaging, refrigerants and temperature monitoring devices.

  • Tightening regulations for pharma shipments:

In the past few years, regulatory requirements on the pharmaceutical supply chain have become ever stricter to mitigate risks during cold chain transportation, to ensure patient safety and to assign clear responsibilities for handling the cold chain. Key international regulatory guidance concerning cold chain management are: The EU Guide to Good Manufacturing Practice (Annex 13), the Guidelines on Good Distribution Practice (GDP) of Medicinal Products, CDC Guidelines for Maintaining and Managing the Vaccine Cold Chain, WHO Guidelines on the international packaging and shipping of vaccines, the US Code of Federal Regulations, US and European Pharmacopoeia. The amended GDP guideline of 2013, chapter 9.2 on transportation for instance stipulates that:

The required storage conditions for medicinal products should

be maintained during transportation within the defined limits as

described by the manufacturers or on the outer packaging. (…)

 It is the responsibility of the wholesale distributor to ensure that

vehicles and equipment used to distribute, store or handle

medicinal products are suitable for their use and appropriately

equipped to prevent exposure of the products to conditions that

could affect their quality and packaging integrity

To ensure the required conditions, tracking and monitoring systems have to be in place that constantly measure the product´s condition.

  • Growing internationalization of the pharmaceutical market:

The pharmaceutical supply chain demands for a global approach as manufacturers and distributors work in different regions of the world. They need to transport medication from the US to Russia, from Europe to China. Thus, they are faced with differences in environmental conditions, like temperature variations, that present a potential risk for temperature-sensitive medication. Tracking the drug´s temperature during transportation is hence an essential part of today’s globalized pharma supply chain.

It seems unlikely that the growth in the cold chain monitoring and tracking market is a short-lived one. This transition requires cost-efficient, reliable tracking devices that match the customer´s needs in a flexible manner.

 

Interesting post? Share it on:
gene and cell therapy: challenges in clinical trial logistics, Gen- und Zelltherapie

Gene and Cell Therapy: The top 5 challenges for cold chain logistics

Interesting post? Share it on:

Gene and cell therapy are the essence of the popular buzzwords personalized medication, patient-specific therapies or targeted medicine. Gene and cell therapy both aim at the direct cause of a disease by replacing or repairing defective genes or cells. These therapies are around for some time, but only in the past two decades have they been applied in a wider range and haven been taken on to an advanced therapy stage. When gene and cell therapies undergo clinical trials, they provide unprecedented challenges for the supply chain – especially for cold chain logistics.

Gene and cell therapy defined

Both cell and gene therapy are fields of biomedical research. Yet, their procedures slightly differ from one another:

  • Cell therapy: This approach implies the injection of whole live cells into a patient. This has been applied broadly in bone marrow transplantation and in oncology. A patient´s defective bone marrow cells are being destroyed by radiation or chemotherapy. Then donor cells, usually of a closed relative, are infused so that they can populate in the bone marrow and replicate. The repertoire of cell types apt for cell therapy is growing.
  • Gene therapy: This approach is designed to insert gene material into cells to compensate for defective genes or to produce an advantageous protein. Since directly inserting a gene does not work, the gene is delivered by a carrier into the cell. Modified viruses are usually used as carriers since they “infect” the cell and thus insert the engineered gene. The modified virus is either injected or administered intravenously as an infusion. That depends on where the defective gene that is to be replaced is located. As an alternative form of delivery, a sample of a patient´s cells can be extracted and then be treated with the carrier virus in a laboratory setting. Then it is returned to the patient.

Why the bar for cold chain logistics is rising

Even though gene and cell therapy have been around for a bit, only lately are they applied more often to rare diseases, neurological, cardiovascular, metabolic or infectious diseases. Research is advancing rapidly as gene and cell therapy is a promising field – aiming at the cause of an illness not merely at its symptoms. This comes to no wonder that more and more clinical trials focus on cell and gene therapies. The number of gen-based clinical trials alone has increased about 500 % in the past 20 years.

Clinical trial logistics procedures in gene and cell therapies are complex and demand a lot of all stakeholder involved in the supply chain. These therapies entail taking up starting cell material from the patients (e.g. stem cells, whole blood etc.) and delivering living cells or viral vectors which have a limited lifespan. This needs strict temperature-management and fast delivery. Even more so since medication is targeted at a single, specific patient which fragments the supply chain.

  1. Keeping up a seamless cold chain:  All the way from and to the patient
  2. Keeping a strict temperature range: According to World Courier most common is 2-8°C, but there are also frozen or cryogenic transports
  3. Sticking to tight delivery times: Living cells must be administered swiftly
  4. Managing cross-border shipments: There are trials that are carried out in 39 sites all over the world
  5. Handling various regulations:  Cross-border shipments need to take into account the different regulations for the handling of living cells in the different countries

Gene and cell therapy clinical trials require safe and 100 % reliable cold chain packaging and logistics providers that are flexible and dependable. The bar for cold chain delivery is raising.

Interesting post? Share it on:
Direct-to-Patient practices in clinical trials, Direct-to-Patient Ansatz

Direct-to-Patient Practices in Clinical Trials – why they are worth the effort

Interesting post? Share it on:

Direct-to-Patient (DtP) practices in clinical trials is a market few players are willing to take on for now. Too high are the requirements that patient-centred trials impose. They make clinical trial design even more complex and increase the strain on all stakeholders to cooperate even closer. Besides, they demand an even greater flexibility and reliability of logistics procedures. So why should anyone turn to Direct-to-Patient practices in clinical trials? The answer is simple: It is worth it.

Problems conventional clinical trials are facing

Recruiting participants for conventional clinical trials is a difficult undertaking. It is time- and cost-consuming to convince participants to enroll in a clinical study and remain until it is completed. Patient-recruitment makes up 32 % of the total trial budget. Thus it is the most relevant factor responsible for increasing clinical trial costs. 50 % of clinical studies are delayed due to patient-recruitment issues – a costly delay affecting not only study costs, but also subsequent sales with losses between 600.000 $ and 8 million $ per day. That is why it is all the more painful to lose already recruited patients during a clinical trial. 30 % of patients drop out at an early stage. One of the reasons they do so is that the site visits are too stressful for them and that they cannot match the trial with their daily schedule. It is clear that participating in clinical trials that involve regular visits to the clinical site obviously provides a severe inconvenience for the patients.

Why Direct-to-Patient practices are the solution

Means to render clinical studies more comfortable for participants is therefore an important goal in conducting clinical trials. And here is where Direct-to-Patient practices come in. DtP implies that the investigational medicinal products (IMPs) are being delivered from the production site (via hubs/pharmacy) directly to the patient´s home. Biological samples are collected at the patient´s site and are then being forwarded to the central laboratory for testing. The patient´s home gets a central locality in this clinical approach and the focus of the latter is set on the patient.

The logistics service provider Marken states that the Direct-to-Patient approach has a positive impact on patient retention and that the compliance is just as high as studies conducted at an investigator site. According to the Medical Research Network (MRN) the Direct-to-Patient model has increased patient recruitment by up to 60 % and has helped maintain patient retention at over 95 %. As a further positive effect, Direct-to-Patient services facilitate access to new participant groups: People that live at a great distance from a trial site and people whose physical state does not allow for regular visits to a trial clinic. Moreover, with fewer participants dropping out, studies can be completed faster and with more reliable results.

3 big hurdles for Direct-to-Patient services

This is all promising, but why then is not every one switching to Direct-to-Patient services? There are three major hurdles to overcome and to consider:

  • Hurdle 1: Since Direct-to-Patient practices are a new approach, most governments do not specify regulations on how a clinical trial with this approach should be conducted. So DtP services operate in a blurry area – regulatory speaking.
  • Hurdle 2: Direct-to-Patient services, at least for now, cannot be applied to each and every trial. They are most suitable for the health care of elderly people, of children and adolescents as well as for patients who need orphan drugs. Overall, the approach makes sense when no intervention is needed as is the case in a biopsy for instance.
  • Hurdle 3: The DtP model requires a close collaboration between stakeholders. Logistics providers, nursing organizations and hub or pharmacy staff have to work together seamlessly to ensure each patient gets the intact medication in the predetermined time window. This is a complex and demanding undertaking.

It is but a matter of time when Direct-to-Patient practices will see a break-through in clinical trials. The players already on the market take on an important role in paving the way. The future has always belonged to the bold.

 

Interesting post? Share it on:
Biologika, Biosmiliars, Biologicals

Biologicals and biosimilars – similar, yet not the same

Interesting post? Share it on:

Approved biosimilars have an “identical pharmacological effect” on the human body. This is stated in the currently published guide to biosimilars by the Drug Commission of the German Medical Association (AkdÄ). Biosimilars correspond to their reference medicinal product in terms of “quality, biological activity, safety and efficacy”. An accolade for biosimilars.

Biological medicines – complex and sensitive

Biologicals and biosimilars are protein-based drugs. They are produced in lengthy and cost-intensive biotechnological processes in living, genetically modified organisms or cells. The amino acid sequence, stays the same, however, as a result of the production in living organisms, the proteins obtained differ in their three-dimensional structure and could thereby trigger different immune responses in the human body. However, clinical data suggests that this is highly unlikely. The batch of a biological is never identical to the previous batch due to the said manufacturing process.

Biosimilars are medicinal products containing a version of the active substance of an already approved biological. The difference between biosimilar and reference medicinal product is no greater than that between the different batches of a biological. This variation is called microvariability or microheterogeneity.

The bioengineered drugs have a delicate structure which makes them different from the unevenly more robust chemically produced medicinal products. Temperature fluctuations and even vibrations can break up the tertiary structure of the drug and make it ineffective.

The fight for biosimilars

Why are biosimilars so heatedly debated? Indeed, you could even call it a battle that has broken out between the market newcomers and the patent-protected biologicals. It is about money and a lot of it. Biologicals generated gross sales of 7.8 billion EUR in 2016 according to the AOK Scientific Institute (WIdO). This comes as no surprise for a syringe of the rheumatoid Humira is sold for over 1000 EUR.

Biosimilars, on the other hand, are around a quarter cheaper than biologicals. Biosimilars can thus save costs in the healthcare system for health insurance companies. The WIdO has determined that the German health insurances saved 77 million EUR last year by switching to biosimilars. And there is still room for further savings. The WIdO sees a potential of another EUR 214 million. With the money saved more patients could be treated with bioengineered drugs.

By 2020 patents of twelve of the highest-selling drugs are running out. These include Rituximab (2013), Infliximab (2014), Trastuzumab (2014), Etanercept (2015), Enbrel (2015), Remicade (2015) and Humira (2018). The manufacturers of the reference drugs had partly tried to slow down their competitors by handing in follow-up patents. Yet, they were not successful. The running out of patents will open the door for biosimilars to the markets a bit wider.

Biosimilars today and tomorrow

The first genetically engineered drug worldwide was human insulin, which was approved in 1982 in the USA and Germany. In 2006, the first biosimilar was approved in the European Union – Omnitrope ©. To date (as of June 2017), 32 biosimilars were accepted by the European Medicines Agency (EMA). Mostly for the two indicative areas of rheumatology and oncology. Although the biosimilars have a great potential to relieve the health care system financially, they are not yet sufficiently spread in the health care system. In 2015 of 656.65 million biosimilar-capable daily doses, only 9.22 million of them were replaced by biosimilars. There are still reservations about the counterfeit products, doctors are reluctant in their prescription, and discount agreements by the health insurance companies makes it difficult for biosimilars to spread. Perhaps the published guideline of the Drug Commission of the German Medical Association (AkdÄ) changes that attitude towards biosimilars. Not least in the name of the patients this switch would be good.

Interesting post? Share it on:
1 2 3 4
Contact

Mon-Fri 9:00AM–5:00PM

+49 (0) 6151 - 80 59 039

info@tec4med.com

Otto-Hesse-Str. 19, 64293 Darmstadt