Ed Price
While manufacturing Active Pharmaceutical Ingredients (APIs) is a costly and time-consuming process, there currently is enormous market demand for APIs to address the challenges of an aging population, and an increasing amount of chronic diseases such as cancer, cardiovascular diseases, diabetes and many others. According to a new market report published by Persistence Market Research, “Active Pharmaceutical Ingredient (API) Market,” the global API market is estimated to reach $186 billion by 2020, up from $127 billion in 2014.
Stuart G. Levy, PhD
Determining practical sources of raw materials and regulatory starting materials (RSMs) that are not produced under good manufacturing practices (GMP) is often far from a trivial pursuit.
Today, more than 10 products on the market include a spray-dried
intermediate (SDI) as a component of their formulation – and there are
hundreds more in development pipelines. With the fast-growing adoption
of SDI, there is increasing pressure to rapidly develop prototype pre-clinical
and clinical formulations so drug products can be seamlessly brought to
commercial scale. As a result, it is increasingly important to understand the
development and scale-up pathway for the progression of SDI.
Subrata Kumer Bose, Armaan Sandhu, Silke Strommenger
Patient recruitment is perhaps the biggest challenge to the success of clinical trials. Inability to recruit subjects in target timelines results in an extensive cost and resource burden on study teams. This reduced efficiency due to the extended recruitment time is a common problem for all drug sponsors costing them millions each year. Approximately
Michael Tanen
Recent advances in translational and personalized medicine initiatives has led to a marked increase in biomarker driven research objectives within clinical trials, thus requiring innovative mechanisms and best practices to manage biomarker specimens collected in global clinical driven trials. To truly fulfill the promise of personalized medicine, we need to incorporate, in real time, specimen metadata, clinical information, and molecular data from a trial to execute translational science.
Stella Stergiopoulos, Kenneth A. Getz
Changing or amending a protocol after it has been finalized is a common and widely executed practice. Amendments are implemented for many reasons including the introduction of new standards of care; revisions to eligibility criteria to stimulate patient recruitment; changes to medications permitted before and during the clinical trial; the availability of new safety data; and requests from ethical review boards and regulatory agencies.
Every Avara location has a long, proven history in the industry and adds to our growing state-of-the-art capabilities, but we are especially proud of the professional experience offered by the personnel at every facility. Avara was founded and is run by an experienced team of industry veterans who understand the working relationship between sponsor and CDMO from both perspectives. Similarly, we understand that it’s important for industry experience to exist at every level of the organization.
Myoderm is a global organization specializing in clinical trial supply. We offer a broad range of procurement and delivery solutions for any company in need of commercial drug product for a clinical trial. With GMP facilities in both the UK and US, Myoderm has been successfully delivering drug product worldwide for nearly 30 years.
Mark Edwards
During the 2015 IQPC Cool Chain & Controlled Room Temperature conference in Frankfurt, a meeting of over 500 industry experts highlighted the huge gaps in the perspectives and focus of the pharmaceutical industry regarding their use of sea freight as an alternative to air freight. It showed that some companies were excelling using this mode whilst others did not know where to start.
Nigel Walker
There seems to be no avoiding it, single-use manufacturing is quickly becoming the norm. Or, as Graeme Proctor, Single-Use Product Manager, Parker Domnick Hunter, phrases it, “Single-use is now widely accepted and people are having to justify why they are not using it rather than justifying why they are using it.”
Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
This column summarizes New Drug Applications (NDAs) approved in May-June 2016. FDA approved 24 NDAs in these two months.
Dalton Pharma Services is a Health Canada approved and FDA registered GMP contract service provider of integrated chemistry, drug development and manufacturing services to the pharmaceutical and biotechnology industries. We bring over 30 years of experience to our clients' projects with an emphasis on quality, speed and flexibility.