The pharmaceutical industry has benefited from high margins and low competition for decades. While the vast majority of engineering effort is directed toward compliance with new regulations and industry best practices, operational efficiency often remains a lower priority item for packaging departments in the life sciences industry.
Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.
Americans' view of the pharma industry is at an all-time low. NSF Health Sciences Global VP Martin Lush says to change that, something radical will have to happen.
Pharma's CMC regulatory affairs staff, R&D leadership, manufacturing, quality and compliance professionals take note: the EU MDR is real, it becomes effective next May, and it brings with it new challenges and regulatory uncertainty for manufacturers of combination products.
While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.
Why Bert Liang, M.D., Ph.D. obsesses over at-scale manufacturing and regulatory challenges from the outset of clinical trials.
Regardless of the maturity of an organization’s data integrity practices, the people component remains the greatest risk. The important thing for individual contributors, operational managers, and executive leaders to remember is that data integrity evolves.
There are many ways to tackle pharmaceutical facility design, engineering, building, and production, and each plant has its own methods and culture. However, there are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events or activities that we have seen and, while they are amusing or baffling, they reveal the flaws in our industry.
More than 13 years ago, Omnitrope (somatropin) received its approval in Europe on April 14, 2006. Since then, as of June 2019, 57 biosimilars from 15 different molecules have received greenlights, 27 of them in the last five years and 16 in the last year and a half. This acceleration is driven by the increasing need to generate savings that help keep pharmaceutical budgets under control. According to data from the consulting firm Fiercepharma, drugs approved in 2019 will generate sales of more than $20 billion in 2024.
There is a growing industry focus on standard operating procedure (SOP) remediation. Although outsourcing, mergers, and acquisitions have been in play for the last 20 years, these activities seem to be skyrocketing, which is creating quite a few scenarios that drive the need for SOP remediation.
Does the pharmaceutical industry want to sit on the sidelines while its products are being manipulated and modified — a danger? Or will the industry provide its products in a manner or with the tools that will enable compounding pharmacies to succeed in delivering a safe and effective drug to the patient — an opportunity?
Qualified Persons (QPs) are responsible for the certification of clinical trial materials in the EU and therefore are an essential link in U.S. sponsors’ supply chains. Indeed, engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated technical, quality, and regulatory challenges.
Pharmaceutical quality by design (QbD) and quality risk management (QRM) principles have become mainstays in pharmaceutical development. However, several myths are prevalent that prevent wider acceptance of the concepts by smaller firms. The lack of understanding of pertinent quality by design methods prevents smaller firms from benefiting from the majority of what QbD offers.
The EMA recently issued two new publications containing information on nitrosamines for marketing authorization holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.
Chemical development is a time-consuming, expensive, and labor-intensive process. Traditionally, new chemicals are developed using batch processing, which fully relies on versatile and qualified equipment to perform different unit operations. To address these above challenges, continuous flow chemistry technology is currently emerging as an effective tool to conduct chemical synthesis, both at the micro and mesoscale, providing an improved product quality with safe and environmentally conducive process in comparison to traditional batch synthesis.
Regulatory approval of a biosimilar requires comprehensive knowledge of both the process and the molecule while process development with the end goal in mind will help to achieve a robust manufacturing process.
There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.
Consistent and repeatable batch operations are key to productivity in pharmaceutical and biotech processes. This white paper shows the importance of precision and repeatability, and describes how reliable, accurate instrumentation allows automation to support quality and productivity strategies.
Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.
This article examines some of the currently available schemes used in generating rAAV from suspension cultures, and describes what it takes to achieve scalable rAAV production.
This free collection of articles is from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.More Content Collections