Significant innovation in disease treatment, including the increased focus on complex biologic therapies1, has resulted in important industry trends that have had an impact on many aspects of aseptic processing.
The year 2018 marks a notable milestone in the history of stem cell and regenerative medicine. It was twenty years ago, in 1998, that James Thompson and John Gearhart published methods for the creation of the first human embryonic stem cell (hESC) lines.
Digital technology has been driving change throughout the life science industry for years, however the sector is currently standing on the precipice of revolutionary development – some organizations have already taken the jump towards a more digital future.
The Falsified Medicines Directive 2011/62/EU, which is due for adoption in February 2019, will require pharmaceuticalcompanies to apply serialisation codes to every applicable pack (OTC and some minor exemptions).
While the requirements for serialization in the pharmaceutical supply chain are generally regarded as inevitable counterfeiting is simply too large of a problem to not be addressed there is some uncertainty around the specifics,particularly globally.
When it comes to the manufacturing of drugs, particularly highly sensitive biologics, a high-level of expertise is required. Typically, small and medium-sized pharma and biotech companies lack the knowledge and know-how necessary to cover all the processes independently prior to completion of the entire final product.
“IGNITE is a creative environment that fosters innovative thinking and encourages new ideas and enables users to have their voice heard in overcoming challenges that are faced to find new ways to better deliver quality data, speed up clinical development, lower cost to drug and device developers, and, to improve patient safety.”
Historically, injectable drugs havemostly been packaged aseptically, with pharmaceutical laboratoriescarrying out the sterilization of the primary packaging components internally.
Aurolab, the manufacturing division of Aravind Eye Hospital, at Madurai, Tamil Nadu that supplies high quality ophthalmic consumables at affordable prices to developing countries.
Do you providecompanies with innovative solutions to improve supply chain efficiency?
In addition to our primary packaging for solid doses, unit dose packaging and secondary packaging services, we also provide integrated supply chain services, such as postponement packaging or late-stage customisation to help our customers cope with small-scale market requirements.
In June 2017, the FDA announced that it will delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) for pharmaceutical manufacturers to November 2018 due to industry-wide concerns that many members of the pharmaceutical supply chain are behind in implementing serialization systems and processes.
The market for organs-on-chips (OOCs), the cell culture chips that imitate the activities, mechanisms and responses of organs, will be worth $284 millionby 2021, according to research from The Business Research Company in its report Organ-On-Chip (OOC) Global Market 2011-21.
Rivaroxaban plus aspirin improves survival and reduces stroke and heart attack in patients with stable coronary or peripheral artery disease, according to late-breaking results from the COMPASS trial presented today in a Hot Line – LBCT Session at ESC Congress1 and published in the NEJM.
The numbers are daunting – 15% of the global population suffers from hearing loss, including a significant number of children, teenagers, and the elderly. Hearing loss presents a growing public health problem, due to ageing and an urban way of life that features excessive noise exposure.
The average cost of bringing a new drug to market is $2.6 billion, according to a 2014 report published by Tufts Center for the Study of Drug Development. This is a rise of 145%, adjusted for inflation, compared to just a decade earlier and is driven in part by the increasing complexity of clinical trials.
Biotechnology and pharmaceutical companies within the United States and Europe face an increasing number of hurdles when undertaking clinical trials within their own country or region; problems such as over saturated patient pools, difficulties meeting and maintaining enrollment numbers, increasing costs and lengthy time delays.
Stem cell science has made huge progress since the early 1960s when Canadian researchers James Till and Ernest McCulloch discovered blood stem cells and advanced medical research across the globe.
Despite the wide array of information systems available for biopharmaceutical manufacturing, we need to adopt a “follow-the-workflow” approach to overcome the process inefficiencies generated by quality and production silos.
In late 2015, I was approached by the board of Nativis, Inc.to take on the leadership of the company, by then a 13-year-old “startup.”
CURE Pharmaceutical has developed innovative drug delivery technology in CureFilm, an oral film strip that dissolves in the mouth, allows for multiple active ingredients in one dosage, and features higher bioavailability.
In recent years the pharmaceutical industry has seen a significant change to the way its manufacturersand supply chains operate, due to the establishment of several serialization and track and trace regulations mandated globally.
Patient-centricity has become an important focus for drug developers and an essential element of clinical studies aimed at showing that a new therapy addresses real patient needs. How companies define patient-centric trials sometimes differ.
Clinical trials are evolving away from trials based solely at investigator sites, moving on to the patient’s home, requiring direct-to-patient services in order for patients to participate.
Life Science companies, both large and small, are seeking more strategic partnerships with vendors.
Worldwide, around 47 million people have dementia, and there are 9.9 million new cases every year, according to recent data from the World Health Organization (WHO)1.Alzheimer's disease (AD) is the most common cause of dementia and may contribute to 60–70% of cases.
1. What makes the market demand rising for integrated delivery system?
The market demand for integrated delivery systems which combine an injectable drug, its container and the system used to administer it—continues to grow due, in large part, to the popularity of self-administered therapies for rheumatoid arthritis, diabetes and other chronic conditions.
A method of testing drugs thatprompt the immune system to attack and destroy cancer cells has been developed which can speed up drug discovering andreducethe unnecessary use of mice in drug screening programmes.
Orphan genetic diseases have become an increasingly popular area for drug development through a variety of novel mechanistictherapeutic approaches.
Automation in its broadest sense has expanded from its original industrial manufacturing base to laboratories and businesses.
The deadlines for serialisation compliance in the EU and the U.S. are drawing closer. For many pharmaceutical companies, the journey towards implementing a full serialisation solution is well underway, but for others the complexity of the task means that there is still a lot to do.
At the discovery and early stages of drug development, the aim is to evaluate the pharmacology, pharmacokinetics and toxicology of a compound using a simple liquid formulation.
The last decade has seen an increased emphasis on research and development into personalized medicines, including cell, gene and immunotherapy treatments
Today, the chief purpose of primary packaging is product protection. However this performance capability has become more challenging in recent years as the complexity of active pharmaceuticals and their supply chain increases.
Regenerative and cell-based therapies have only recently begun to deliver on the promise they have portended for years, creating opportunities to positively impact patient outcomes and professional success.
Managing site payments is not an easy task. They are frustrating, burdensome and a drain of time and resources. CROs, specifically project managers, are often tasked by their sponsor partners to manage the site payment process and consequently are deemed at fault for any issues that arise, such as late or inaccurate payments.
The problem defined: Any prospective new drug must successfully pass a succession of three clinical trials phases, before it can apply for market approval.
A look at how pharmaceutical manufacturers can benefit from the use of dynamic checkweighing technology to comply with international standards, increase process safety, productivity and process control.
Type 2 diabetes awareness is rising in the United States. Public and private health leaders are now offering screenings and patient education sites that discuss “prediabetes,” to detect and treat the disease in its earliest stages.
Clinical research generates extensive amounts of data, yet most of it is siloed or generally unavailable to a larger pool of willing potential researchers.
Finding suitable patients to participate in clinical trials is a long complicated process taking months today.The emergence of electronic hospital records (EHRs) in a hospital information system (HIS) allows this process to be automated and accelerated.
When unplanned events such as weather delays cause product spoilage, it’s easy for healthcare executives to react by instituting an across-the-board increase in insulation material.
The impact of the DataMatrix code in the pharmaceutical industry has been immense. Offering high standards of data quantity and security, this two-dimensional matrix barcode has become the standard code carrier for a number of regional and country-specific serialization initiatives.
Although it may not be the first component that comes to mind when thinking of a pharmaceutical package, closure liners play a critical role in delivering tamper-evidence, supporting product integrity and protecting the package during the distribution cycle.
For the pharmaceutical industry, keeping all regulatory requirements is a top priority not only in development and production, but also for the storage and distribution of drugs, active substances and medical products.
January 1, 2015 initiates a step-wise supply chain mobilization towards a new era of pharmaceutical product serialization in the US. The US is not the first country to institute measures to control suspect and illegitimate drugs.