Articles

The Covid-19 crisis has underlined the need for global data standards, such as ISO IDMP (Identification of Medicinal Products), in the life sciences sector. Remco Munnik of Iperion Life Sciences Consultancy reviews progress towards IDMP in 2020 and outlines key developments expected in 2021.
Amid the disruption of 2020, there has been huge emphasis on healthcare and the role of the pharma organisations, marketing authorisation applicants and holders (MAAs and MAHs), and of regulators, in a crisis. Speed to market (bringing relevant medicinal products, for example new vaccines, to market swiftly), yet also thoroughness in safety and quality assessments, have become paramount and visible to a much greater degree in society. Countries, governments, health care providers, entire societies are c…

Owing to the rising prevalence of diseases, soaring government and non-government initiatives and policies, and surging healthcare expenditure, the adoption of single-cell analysis is predicted to rise in the coming years. The escalating healthcare expenditure, especially in the developed nations, is resulting in a huge rise in the incorporation of single-cell analysis procedures and products, such as consumables and instruments. Moreover, single-cell genomics in disease analysis allows for better personalized treatment procedures that involve the tracking, monitoring, and treatment of patients according to their individual needs.
The other major factors boosting the demand for single-cell analysis are the surging geriatric population, growing need for personalized treatment plans, and the…

First Responders may not be direct partners in the pharmaceutical supply chain, but they are equally responsible for the safety and security of drugs. There are ways to identify that the first responder is using the drugs legally and correctly. From T3 transactions to tracking first responders or dispensers, this article explores the exit point of the supply chain in details.
A lot is known and understood about the operations of a drug supply chain in the United States, which is transforming to cope with the ever-changing requirements of the DSCSA and the drug industry in the country. While everything that the DSCSA says and the participants do root in eliminating the counterfeit drug marketing in the US, compliance standards have evolved into something more prolific than just maintaining p…

No matter what stage of pregnancy you are in, a Kegel exercise can provide you with several benefits. We recommend that you choose and do the exercises that suit you. It is very beneficial for pregnant women to do Kegel exercises during pregnancy and after birth. These exercises, Dr. It was presented to pregnant women by Arnold Kegel for strengthening and working the muscles in the pelvic area. Have you heard of Kegel training before? These types of exercises are very useful for improving some of the negative aspects of pregnancy. Therefore, we will show you some of its most important benefits and you will definitely be convinced to do them.
Kegel exercises for pregnant womenIt supports the pelvic floor muscles, organs such as the bladder, urethra, and uterus, as well as organs such…

Oxygen is the most vital non-metallic element in the planet earth’s atmosphere making up around 21% by volume and 23% by weight of the air.
Oxygen is the most vital non-metallic element in the planet earth’s atmosphere making up around 21% by volume and 23% by weight of the air. It is crucial for maintaining life on the planet as it is essential for breathing. In medical science, oxygen is very important for treatment of patients suffering from hypoxemia, low level of oxygen. Medical oxygen is used for treatment of health disorders such as asthma, COPD, sleep apnea, breathlessness, etc. It is also used in surgery, as life-support system and ambulances. Benefits Of Using Medical Oxygen Plant For getting high purity oxygen you would need a medical oxygen plant for processing atmospheric oxyg…

Do you know everything about return saleables? Do you know how to use it as a stepping stone to achieve DSCSA compliance? What are the critical success factors determining the success of verified return saleables? The article talks in details about the warehouse equipment required for VRS, the right tools required for verification, and the storage requirements during the VRS process.
The VRS-compliance deadline may have been pushed by 3 years, but following the journey to complete compliance, be it VRS or others, continues. The drug supply chain stakeholders were on their toes to get the right equipment to ensure that a delay in compliance does not come in their supply chain management. Now, they can relax and take their time for compliance. However, the need for supervision still remains.…

Covid-19 has tested supply chains across all sectors to their limit. For the European medtech supply chain – responsible for employing around 730 000 people – the pandemic has revealed that key lessons need to be learnt in order to maintain a consistent supply of equipment during turbulent times whilst also managing expenditure. A new report released by European MedTech supplier Healthcare 21 Group (HC21), sheds light on how healthcare businesses can maintain efficiency across supply chains during global disruptions brought by Covid-19 and Brexit. Here, David Plotts for HC21 explains how.
One of the main issues to have arisen out of Covid-19 is keeping hospitals stocked with enough equipment to cope with the hundreds of thousands of cases being referred to their facility. This is particula…

Want to work somewhere different? We all have clear goals to reach at Abcam, and we’re encouraged to be original in how we get there. No matter your role, be it a Credit Controller or a Lab Technician, we know that tried-and-tested doesn’t always mean best. Dare to be different, dare to be ambitious, and you’ll help us change the game in our industry.
Q&A with Marco - Research Associate, Custom solutions • Tell us a little bit about your self, role exp.I graduated with a MSc in Biotechnology last year in Italy, and I came in the UK to learn and develop new skills. In January I applied for a position as Research associate in the Custom solution department. I started working at Abcam in March. Now I am leaving the company because I decided to do a PhD. The expertise and knowledge I gain…

Distributed Ledger, even though a new entrant in the complex pharma supply chain ecology, has taken data connectivity and traceability to a new level. Here’s exploring what it is in details.
We have spoken in details about various aspects of traceability in the pharma supply chain- serialization, hierarchical data, aggregation and more- all meant to save drugs from the counterfeit market. However, owing to the ever-changing dynamics of the pharmaceutical industry and its growing complexities, it would be unfair to stick to certain technologies over time. So, as we approach the future of traceability, we have to adopt technologies designed considering the changing ecology and demands of the drug supply chain in mind. The main aim of introducing traceability, as per DQSA act, is to eliminate…

Macrophages are white blood cells that engulf and digest cellular debris, foreign substances, microbes, and cancer cells. Recently, scientists are exploring the method to make macrophage stronger, that is to give it a CAR. These CAR-M cells are expected to efficiently treat tumors.
Macrophages are common phagocytes in various mammalian tissues, which play many different roles in normal development, homeostasis, tissue repair and even immune response to pathogens. Their diversity means that they are involved in almost every human disease, and are also the main therapeutic target because their functions can be enhanced or inhibited to change the circumstances of the disease. What are macrophages? In the word macrophage, "macro" means "huge" and "phage" refers to phagocytes. Phagocytes are s…

Pharma Aggregation is the new buzz word in pharma serialization, especially when industry experts have realized what packaging-level serialization can do to ensure the integrity of the medicines. Implementing aggregation is the need of the hour because there’s a drastic rise in the counterfeit medicines during the pandemic, posing greater threat to humanity. So, here’s discussing the past, present and the future of pharma aggregation.
DSCSA is changing the dynamics of the pharmaceutical supply chain since its inception. Scripted with the aim of eliminating counterfeit drugs, which comprises 60% of the total medicine circulation in the market, DSCSA is serving more purposes. Merely creating guidelines to be followed by the pharmaceutical stakeholders during the production line of drugs is o…

How fantastic is it to see that the National Organisation for Rare Disorders (NORD) has followed up on a survey undertaken in the late 80’s to pressure test progress and identify key challenges still faced by the rare disease community in the US. This feels even more timely given the current impact of COVID-19 on health systems, families living with rare disease and the predicted future impact on healthcare budgets. In this article we will look at the findings and explain how they influence our solutions to drive better outcomes for patients and clients into the future.
Data collection methods in the surveys reflect the technology widely available at the time and were on roughly similar numbers of patients and proportions of female and male respondents. The results have been segmented in…

VRS-compliance is merely a part of DSCSA compliance. But that’s not enough because there are a number of things that need to be considered while achieving one milestone at a time. So, here’s a checklist with all the important pre-requisites for DSCSA compliance by 2023. Some of the important points of discussion would be the importance of FDA-NDC, what are FDA labelers, and how multiscanners help in streamlining VRS compliance with the help of look-up directories and FDA labelers.
According to WHO, one in 1 in 10 products in developing countries are found to be fake, which not only lead to fatalities but also dupes the economy of close to $200 billion annually. Each year close to 250,000 children die because of consumption of counterfeit drugs and similar effects are visible among the elde…

Stryker has announced it has cleared all regulatory hurdles previously in the way of its planned $4.7 billion acquisition of Wright Medical. The tender offer was initiated back in November 2019 and has now been completed as of November 11, 2020.
Stryker has announced it has cleared all regulatory hurdles previously in the way of its planned $4.7 billion acquisition of Wright Medical. The tender offer was initiated back in November 2019 and has now been completed as of November 11, 2020.  “Wright Medical has built a successful business, and together we look forward to working with customers to continue delivering solutions that improve patient outcomes,”  Kevin Lobo, Chairman and Chief Executive Officer, Stryker Wright Medical was founded in 1950 in Memphis by an orthop…

As we progress through the global pandemic and drive closer to having a vaccine available, companies are now preparing supplies such as needles and syringes. We have compiled the top three companies to watch as distributors for needles and syringes in the United States.
As we progress through the global pandemic and drive closer to having a vaccine available, companies are now preparing supplies such as needles and syringes. We have compiled the top three companies to watch as distributors for needles and syringes in the United States. Becton Dickinson  Cardinal Health Novo Nordisk Becton Dickinson Becton Dickinson produces billions of syringes and takes advantage of economies of scale to produce and sell syringes at a lower cost than many of its competitors. Our analysts expect them…

In highly regulated industries your labelling must speak for your product – compliance is non-negotiable! Computerised systems validation is essential for medical device and pharmaceutical manufacturers. Here, Beth Peckover, VP Global Delivery at Kallik, pinpoints the three areas businesses need to get right to ensure computerised systems used for labelling meet all GxP requirements set out by industry regulators.
In highly regulated industries your labelling must speak for your product – compliance is non-negotiable! Computerised systems validation is essential for medical device and pharmaceutical manufacturers. Here, Beth Peckover, VP Global Delivery at Kallik, pinpoints the three areas businesses need to get right to ensure computerised systems used for labelling meet all GxP requir…

Surge in negative returns during the VRS process in the drug traceability industry can cause millions of dollars to companies. Negative returns are often incurred when single scanners are unable to screen through 2D barcodes, which multiscanners can do. The use of AR-enabled multiscanners can bring improvement in the rate of negative returns by eliminating the chance of non-readability.
A lot has been discussed about the building blocks of traceability- Unique identification through serialization, data capture through 2D and Datamatrix barcodes, link management and data communication through scanning; Thanks to the Drug Supply Chain Security Act requirements that have kept all the stakeholders of the pharmaceutical industry, one of the oldest industries in the world, busy with the realizat…

Do you know everything about return saleables? Do you know how to use it as a stepping stone to achieve DSCSA compliance? What are the critical success factors determining the success of verified return saleables? The article talks in details about the warehouse equipment required for VRS, the right tools required for verification, and the storage requirements during the VRS process.
The VRS-compliance deadline may have been pushed by 3 years, but following the journey to complete compliance, be it VRS or others, continues. The drug supply chain stakeholders were on their toes to get the right equipment to ensure that a delay in compliance does not come in their supply chain management. Now, they can relax and take their time for compliance. However, the need of supervision still remains.…

VRS-compliance is merely a part of DSCSA compliance. But that’s not enough because there are a number of things that need to be considered while achieving one milestone at a time. So, here’s a checklist with all the important pre-requisites for DSCSA compliance by 2023. Some of the important points of discussion would be the importance of FDA-NDC, what are FDA labelers, and how multiscanners help in streamlining VRS compliance with the help of look-up directories and FDA labelers.
According to WHO, one in 1 in 10 products in developing countries are found to be fake, which not only lead to fatalities but also dupes the economy of close to $200 billion annually. Each year close to 250,000 children die because of consumption of counterfeit drugs and similar effects are visible among the elde…

Demanding, high-volume document and data processing-based tasks make Regulatory operations administratively labour-intensive, so interest in robotic process automation is understandable. But where is the technology’s ideal application, and how can life sciences firms extract maximum benefits? Amplexor’s Agnes Cwienczek offers a reality check.
Demanding, high-volume document and data processing-based tasks make Regulatory operations administratively labour-intensive, so interest in robotic process automation is understandable. But where is the technology’s ideal application, and how can life sciences firms extract maximum benefits? Amplexor’s Agnes Cwienczek offers a reality check. The potential for transforming workload management in Regulatory operations using robotic process automation (R…