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Containment/delivery systems for sensitive biologic drugs must provide the chemical, physical, and performance properties required to ensure product quality through shelf life. Further, they must be compatible with fill/finish operations, and enable functional performance during administration. Legacy rubber components may no longer meet the increasing technical and regulatory requirements of current and future biologic drug products.
Even though the regulatory landscape is steadily evolving, pharma companies sometimes rely on rubber formulations existing since the 1980’s, or even since the 1960’s in some cases. This is well before many industry guidances were published, such as:
For example, regulatory authorities now are placing high demands on pharma companies to reduce and control levels of particles and fibers. Looking ahead, personalized medicine will increase these demands as the impact per injection is dramatically higher. Legacy rubber formulations were not designed with all this in mind. Though improvements in these formulations have been made, there are chemical and physical limitations that cannot be overcome. New rubber formulations are needed.
An example of such a new rubber formulation is West’s 4040/40 Gray. It was designed using quality-by-design principles, selecting raw materials and processes that would provide best performance in terms of particles, extractables, and functionality. Having been developed to anticipate future technical demands, it can serve as a platform for the future.If you want to learn more about this topic, and others, you have the opportunity on Feb 4, 2020 in Paris when West experts present at the West Educational Series.
Particulates in injectable drug products continue to be an area of great interest in the industry. The main reason is the potential clinical effects on patients, which can range from emboli to inflammations to infections. There are a series of clinical risk factors that should be considered in evaluating and mitigating these challenges. These factors are route of administration, patient population, and particulate composition (i.e., number, size, and shape). All are critical inputs to understanding risk and determining corrective and preventative actions.
<p>Patients rely on drug products to help protect their health and prevent complications. Pharmaceutical manufacturers rely on a drug product’s primary packaging container and delivery system to maintain the drug quality and ensure that their drug is delivered safely and effectively. But like any drug product, there are risks associated with containment and delivery systems.</p><p>On February 23, West hosted a training event, “Understanding Risks Associated with Containment and Delivery Systems Across the Biologic Product Lifecycle from Formulation to Commercialization” a joint presentation from West, Patheon and the National Institute for Bioprocessing Research and Training (NIBRT).</p>
West Pharmaceutical Services team members performed especially well this year for the Janssen Supply Chain Global Procurement Organization (a part of the Johnson & Johnson group of companies), which recently presented the team with the bronze Supplier Award. The award was presented during a ceremony at the J&J facility in Turnhout, Belgium, on May 7.
On June 20, representatives from West joined Chairman and CEO Donald E. Morel, Jr., Ph.D., to celebrate the company’s 90th anniversary by ringing the closing bell at the New York Stock Exchange. The closing ceremony at the stock exchange commemorates West’s long history of working side-by-side with top pharmaceutical, biotechnology and medical device companies around the globe to solve the challenges of delivering life-changing therapies safely and effectively to patients.
QbD, CQA, QTPP,FEA – what does it all mean? Quality by Design (QbD) can be confusing, but it really doesn’t have to be. QbD was designed to promote an understanding of the product and manufacturing process starting with product development. When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to assure consistent product quality.
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