As shared in our previous blog post, "Cell Gene Therapy and Viral Vectors," the making of a vaccine is a complex process that requires extensive knowledge and expertise to minimize all potential risks that could be a threat to human life. The vaccine industry used to be relatively small, but due to recent events, there is more demand for expertise in the field.
As shared in our previous blog posts about the vaccine industry and cell gene therapy, the making of a vaccine is a complex process that requires extensive knowledge and expertise to minimize all potential risks that could be a threat to human life. The vaccine industry used to be relatively small, but due to COVID-19, the industry has only grown.
Who would have thought that genes and cells can be manipulated in such a way to treat and cure compromising diseases? Cell gene therapies, also known as monoclonal treatment, have brought a new era in the biotech industry as a way of treatment for many compromising diseases like cancer, diabetes, genetic disorders, blindness, muscular dystrophy, and even Alzheimer’s. Now, these therapies are aiming to treat COVID-19.
Over the past year, the emergence of COVID-19 has pushed the BioPharma industry to deliver faster than ever before, yet it can be hard for any industry to keep up with such demand.
Cross-contamination is a potential risk within the vaccine manufacturing process, especially if different products are processed in the same controlled rooms. Cross-contamination can occur if required controls are not in place to eliminate risks that could impact product quality and, most of all, compromise human lives.
EG Life Sciences, a company of Eliassen Group, is proud to share big news within our extended family. Recently, Eliassen Group unveiled an updated brand to reflect their expanding service offerings, reinforce their company values, and more directly communicate the value they provide their clients.
As more vaccines for COVID-19 emerge, safety in the vaccine production process is crucial. Any foreign matter entering the vaccine production process raises major safety concerns, and contamination is a common occurrence and a public health risk.
All of us who work in the Biotech industry or the pharmaceutical industry, including those of us at EG Life Sciences, face daily challenges to maintain an aseptic environment. Rigorous safety standards are in place to avoid any cross-contamination and/or any foreign matter being introduced to the vaccine production process. However, there is still a chance that this could happen.
The biggest question on the minds of leadership at pharmaceutical companies is 'how do we respond more quickly to this rapidly changing market?' Regulatory requirements are changing constantly, companies need to keep up with the digitization prominent across the industry, and there's mounting pressure for drugs to be delivered more quickly. Now that the Covid-19 vaccine has been delivered to market in 9 months, others are interested in how that is possible.
Is your company as far along as it needs to be?
The In Vitro Diagnostics Regulation, or the IVDR, was created to ensure a greater level of patient protection and regulation around the creation of in vitro diagnostic devices (or IVDs). The IVDR will replace the legacy In Vitro Diagnostic Directive (IVDD) and should ensure a greater level of patient protection and provide rules and regulations that are more effectively implemented.
The manufacturers of these devices are well aware of the IVDR that will soon take effect. Most of these manufacturers are already taking the necessary steps to prepare to comply with this new regulation, but are they as far along in their preparations as they should be?
In an age when your daily wants and needs can be delivered by Amazon, we are a culture of instant gratification. This culture has bled into all walks of life, including our medicine. In June of 2018, Amazon bought PillPack out of Cambridge, MA, for $753 million to crack into the $500 billion dollar prescription market. With this acquisition, customers can get meds delivered to their door with automatic refills and 24/7 customer support.
What are Net Promoter Scores?
Have you heard of Net Promoter Scores? A company’s NPS or Net Promoter Score is a measurement of customer satisfaction.1 These scores are especially useful in the staffing industry, in which feedback isn’t linked to a tangible product, but is instead related to a more subjective service or experience. For example, when a client says their experience with us was “good,” it’s difficult to derive true meaning from that response, especially as the definition of “good” likely varies vastly from client to client. Thus, the staffing industry was in need of a universally understood, tangible measure of a subjective experience. Enter NPS. While NPS surveys can ask a number of questions, the concept truly focuses on only one:
How likely are you to recommend your firm to a friend of colleague?2
When the FDA inspects a pharmaceutical or biotechnology company’s manufacturing facilities, they can either alert the company ahead of time or show up unannounced. After the inspection is over, the FDA might send what is called an FDA Form 483 or a warning letter. There are differences between each and varying consequences depending on how each of these is handled.
In our recent blog post entitled Prepping for a Successful FDA Inspection, we discussed the importance of having a Site Inspection Readiness Team always “at the ready” for FDA visits, regardless of whether the visits are scheduled or unannounced. But what happens once the inspectors arrive? You should have a checklist on hand for the key logistical considerations.
Don't limit your team's ability to perform. Consider freeing up your best internal resources by using an outsourced team as an extension of your functional group.
It’s certainly a challenge that most – if not all – companies face these days: which aspects of our business do we keep in-house, and which pieces do we outsource? And nowhere is that more of a challenge than within the regulated environment of the pharmaceutical industry.