Articles

Microbial limit test is performed to determine whether drug products comply with an established specification for microbial quality.
Microbial limit test is performed to determine whether drug products comply with an established specification for microbial quality. USP <61> and USP <62> for objectionable organisms are usually the guidelines for testing as specified by FDA requirements. In most cases, the microbial limit test covers the following three test items: Total Aerobic Microbial Count In this step, the total number of aerobic organisms is determined, which is an important indicator to measure the hygienic quality of medicines. Total Combined Yeasts and Mold Count In this step, the number of contaminated viable bacteria (yeasts and mold) in the unit mass, volume…

The quantitative analysis of a small amount of amorphous existence plays a vital role in the process of drug development and production.
In industrial production, the surface of the compound may become amorphous due to a small amount of structural damage. It is difficult for conventional instruments to detect this small amount of amorphous substance. Although the content of this amorphous substance is very low, it is very likely to affect the stability of the drug in the production and storage process, resulting in the failure of the entire development. Therefore, even the quantitative analysis of a small amount of amorphous existence plays a vital role in the process of drug development and production. Amorphous content determination and identification The qualitative and quantit…

Prescriptions are one of the types of medical treatment that we may expect to encounter the most throughout our lifetime. Whether for the long term, chronic conditions such as diabetes or asthma, a short term injury or illness, or as part of a contraceptive plan, prescription medications can effectively treat a wide range of health conditions.
The State of England's Prescriptions 2021 Prescriptions are one of the types of medical treatment that we may expect to encounter the most throughout our lifetime. Whether for the long term, chronic conditions such as diabetes or asthma, a short term injury or illness, or as part of a contraceptive plan, prescription medications can effectively treat a wide range of health conditions. However, there’s much debate over how we use prescriptions as a nat…

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your clinical trials. This article explores the features that a clinical MDR software should have.
It’s tough trying to choose and implement new software and systems. And clinical metadata repositories (MDRs) are no exception. But, they’re a must these days. Everything’s moving towards efficiencies and automation. You don’t want to get left behind. So what should you expect as a given when it comes to a clinical metadata repository? Well if the clinical metadata repository you’re looking at doesn’t meet these basic specifications, find another one that does! Or you could be wasting your time – and potentially a lot of money too. Here’s…

Automation is used to improve the accuracy of results in the clinical trial process from study setup through to submission. It removes manual processes such as creating forms and annotations by hand or entering data manually onto a spreadsheet. Results are accurate as human error is reduced. Automation also makes it easier to comply with the standards required by regulatory authorities, such as the FDA.
Many companies in the life sciences industry are slow to adopt new technologies. This is down to greater costs, greater operational burden, and uncertainty with meeting the complex regulatory requirements put in place. However, there has been a lot of advancement in new and emerging technologies for automating clinical trials in recent years. The FDA has recognized their benefits a…

Microbial limit test is performed to determine whether drug products comply with an established specification for microbial quality.
Microbial limit test is performed to determine whether drug products comply with an established specification for microbial quality. USP <61> and USP <62> for objectionable organisms are usually the guidelines for testing as specified by FDA requirements. In most cases, the microbial limit test covers the following three test items: Total Aerobic Microbial Count In this step, the total number of aerobic organisms is determined, which is an important indicator to measure the hygienic quality of medicines. Total Combined Yeasts and Mold Count In this step, the number of contaminated viable bacteria (yeasts and mold) in the unit mass, volume…

SMi Group reports: ahead of the conference in February 2022, a snapshot or key speakers and presentations are released
SMi Group are delighted to announce the 13th Annual Conference RNA Therapeutics, taking place on the 9th and 10th February 2022 in London, UK. The 2022 Conference is on bolstering the latest advances and opportunities in RNA-based medicine. Interested parties can register at: http://www.therapeutics-rna.com/PR2PW  - take advantage of the early bird offer and register by 30th November and save £200. Building on the success of previous years, the RNA Therapeutics Conference will bring together industry experts from leading RNA therapeutics companies to gain an expert and holistic view on the latest developments of the industry. With this in mind, SMi Group have released…

Australia’s Global Talent Visa was introduced as part of the Australian government’s JobMaker plan which focuses on improving talent migration to Australia. It attracts highly qualified and exceptionally talented individuals to live and work in the country as permanent residents, and is aimed at those who can demonstrate skills and expertise in specific target sectors.
Australia’s Global Talent Visa was introduced as part of the Australian government’s JobMaker plan which focuses on improving talent migration to Australia. It attracts highly qualified and exceptionally talented individuals to live and work in the country as permanent residents, and is aimed at those who can demonstrate skills and expertise in specific target sectors. This streamlined visa pathway is designed to support Aust…

As drug and medical device production ramped up to respond to the pandemic, manufacturers faced the challenge of more effectively monitoring, analysing, reporting and acting on quality performance. Siniša Belina, senior life sciences consultant at Amplexor, reveals the latest best practice.
Across a whole swathe of industries the Covid-19 pandemic has shone a light on restrictive business processes, information silos and poor supply-chain visibility. In life sciences manufacturing, for instance, a range of challenges linked to quality management have been exposed and starkly felt. On the one hand, public safety measures over the last 18+ months have put physical distance between team members - hampering the usual form-filling, manual sign-offs and Excel-based record-keeping associated with…

The pharma industry is continuously striving to be more customer-led in its activities, but the healthcare ecosystem is complex, meaning that product teams must consider the relative needs of a whole range of stakeholders. Here, drawing on new research, Malte Scholz of airfocus discusses what’s needed today to navigate and balance those differing priorities.
For all that pharma organisations claim to have refocused their efforts around customers over the last decade or more, mapping new developments to tangible outcomes isn’t easy. In pharma, this challenge is particularly acute due to the diversity of stakeholders with views on what they want from next-generation products. In addition to the ultimate customers (patients), physicians, speciality clinicians, regulators, payers and insurers a…

In this article, we’ve put together a list of the best Life Sciences organisations to work for in the UK, using the official rankings given by The Great Place to Work Institute in 2021.
In this article, we’ve put together a list of the best Life Sciences organisations to work for in the UK, using the official rankings given by The Great Place to Work Institute in 2021… Small Workplaces (20-50 Employees) Chugai Pharma Europe Chugai Pharma Europe employs more than 250 experts across eight European countries, including in London, UK, where around 46 employees work. This pharmaceutical organisation ranked 17th in the UK’s Best Small Workplaces list. 97% of employees are proud to tell others they work for the organisation, with 95% agreeing that management is honest and ethical in its business p…

The 2020 Stress in America survey by the American Psychological Association (APA) revealed that the COVID-19 pandemic was a significant source of stress for nearly 80% of Americans(1). While stress is a part of life, it’s possible to manage our stress response effectively and use various methods to channel the energy. Certain diseases can also cause stress. For example, research shows that Lyme disease might also be linked to anxiety a
The 2020 Stress in America survey by the American Psychological Association (APA) revealed that the COVID-19 pandemic was a significant source of stress for nearly 80% of Americans(1). While stress is a part of life, it’s possible to manage our stress response effectively and use various methods to channel the energy. Certain diseases can also cause stress. F…

Frits Stulp of Iperion – a Deloitte business, outlines ambitions for a new era of informed choice for patients, physicians and other stakeholders across the healthcare ecosystem – if pharma companies take the right decisions now about data-driven process transformation.
The ISO IDMP data standards currently being implemented across the EU offer an important facilitator for change in the way that patients, and stakeholders right across the healthcare ecosystem, will engage with and choose treatments in future - as long as the industry encompasses the potential as part of current internal IT and process revisions. Empowering patients & frontline health workers The internet is connecting all kinds of healthcare stakeholders to the information they need now. Examples range from sick student…

Attracting candidates away from big pharma can be challenging, especially if your organisation doesn’t have the budgets to match the competitive packages offered by these large companies. However, recent research has proven that attracting high quality talent isn’t all about offering the highest salary or the most benefits, and this is especially true for younger generations of jobseekers.
Attracting candidates away from big pharma can be challenging, especially if your organisation doesn’t have the budgets to match the competitive packages offered by these large companies. However, recent research has proven that attracting high quality talent isn’t all about offering the highest salary or the most benefits, and this is especially true for younger generations of jobseekers. A 2020 survey b…

For the first time, companies are prioritising quality over cost for pharmacovigilance automation. John Price, life sciences industry consultant and advisor to Arriello, which commissioned this latest research, presents the findings of a brand new transatlantic survey into the industry’s PV automation intentions.
Although the COVID-19 pandemic has stalled progress with digital process transformation, many life sciences companies’ ambitions to apply smart solutions to rising pharmacovigilance workloads remain central to the investment agenda. These are the findings of Arriello’s second annual transatlantic survey of 200 professionals in senior roles spanning PV, Drug Safety and Product Safety departments. This year, quality overtook cost to become the primary criterion for automating PV work…

Gaining prompt and profitable market access for the latest drugs is challenging. Competition for advanced treatments is increasing, yet the products are more tightly targeted and more expensive to develop which has an impact on the available market size and ROI. Here, Jean-Luc Taborin of ProductLife Consulting proposes 5 steps biotechs and biopharma companies can take to accelerate the delivery of commercially-viable next-generation treatments to the patients who need them.
Next-generation biopharma products are entering the market in growing volumes, meaning that biotechs are in competition with more established pharma companies for market access and the best pricing and reimbursement terms, despite limited resources. Compared to traditional blockbuster drugs, these novel treatments are mo…

Clinical Research is a branch of Life Sciences that investigates the safety and effectiveness of new treatments and the suitability of these treatments for human use. Particularly over the past 18 months, the global Clinical Research market is continuously growing and evolving, with more and more career opportunities becoming available within this vast field. In this article, we look at 10 different career paths within Clinical Research.
Clinical Research is a branch of Life Sciences that investigates the safety and effectiveness of new treatments and the suitability of these treatments for human use. Particularly over the past 18 months, the global Clinical Research market is continuously growing and evolving, with more and more career opportunities becoming available within this vast fiel…

In this article, we look at nine of the top pharmaceutical companies with headquarters in the United States.
In this article, we look at nine of the top pharmaceutical companies with headquarters in the United States… Merck & Co. Founded over 130 years ago, Merck’s mission is to be the premier research-intensive biopharmaceutical company in the world. They are focused on bringing forward treatments for the world’s most challenging diseases to save and improve lives. Headquartered in New Jersey, Merck has more than 74,000 employees and in 2020 reported worldwide sales of $48 billion. Johnson & Johnson Also founded over 130 years ago, Johnson & Johnson is the world’s largest healthcare company, striving to improve access and affordability and create healthier communities for all.…

Starting a new job can be a big adjustment, but there are things you can do to really make the most of the first few days, weeks, and even months in your new role. In this article, we outline 14 things you can do when starting your new job; from introducing yourself to your new colleagues to setting boundaries and tracking your progress.
Starting a new job can be a big adjustment, but there are things you can do to really make the most of the first few days, weeks, and even months in your new role. In this article, we outline 14 things you can do when starting your new job; from introducing yourself to your new colleagues to setting boundaries and tracking your progress. Prepare Your Introduction You’ll be introducing yourself to so many new faces, so think about what you want people to kno…

Pharmacy aseptic units are a cornerstone of many critical NHS services; they provide sterile products such as injectable nutrition, chemotherapy treatment and central intravenous additive services (CIVAS). Aseptic services have teams of skilled pharmacists, technicians and assistants to dispense and prepare these treatments.
Pharmacy aseptic units are a cornerstone of many critical NHS services; they provide sterile products such as injectable nutrition, chemotherapy treatment and central intravenous additive services (CIVAS). Aseptic services have teams of skilled pharmacists, technicians and assistants to dispense and prepare these treatments. COVID-19 has amplified the need to transform aseptic services to deliver better clinical outcomes, improve patient experiences, and release time sp…