![]() ![]() The supply chains of the modern pharmaceutical industry are global and complex, and though drugs under patent enjoy some protection with respect to their ability to make profits, generic competition creates fierce pressure, cutting the prices of many drugs. But each technique has different strengths and weaknesses, which make it well suited to a particular application – or ill suited to another (4).Īnalytical data is also important when considering the supply chain. For instance, as shown in Figure 1, particle size (an important variable for many pharmaceutical products because of its influence on characteristics such as bioavailability and dissolution behavior) can be measured using several techniques. Casting a wider analytical net can also provide solid evidence of a company’s understanding of the factors affecting the integrity of critical measurements. This core physical technique robustly quantifies internal structure, but tends to be underused by the pharmaceutical industry because of the health and safety concerns associated with working with mercury and a lack of understanding of the benefits of the technique. Mercury intrusion porosimetry is a good example of a technique that may be excluded from a narrowly prescribed analytical schedule, but can add value to more comprehensive characterization of granules for tableting and/or finished tablets (3). In reality, demonstrating a robust product understanding not only underpins a successful submission but also lays the foundation for the effective supply selection and process troubleshooting needed for long-term economic manufacture. But establishing a more comprehensive package of measurements for APIs or formulation is entirely consistent with the QbD approach and can pay dividends throughout the lifetime of a product. ![]() The risk of making such requests, however, is that that they may drive up the cost of outsourcing. Rather than dictating conversations with requests like, “I’d like to measure the particle size of these granules by laser diffraction”, companies should consider making more open-ended requests such as, “I’d like to characterize these granules to develop correlations between their properties and those of tablets manufactured from them”. Though companies hold the expectation that outsourcing partners will be able to provide high-quality data in a closely specified timeframe – at competitive prices – a question remains: how do you develop a relationship that best draws upon the strengths of both parties? In my experience, making broad requests of a contract lab offers their experts greater scope to contribute as an equal partner in the research process. In 2018, the global pharmaceutical analytical testing outsourcing market was valued at $5.59 billion and is set to grow by 8.1 percent over the next seven years. Choosing a good contract laboratory or analytical service gives you access to a broad range of equipment as well as in-depth expertise. The accrual of savings holds value for many as the need to invest in and use new instrumentation and train staff falls away. In fact, in 2018, the global pharmaceutical analytical testing outsourcing market was valued at $5.59 billion and is set to grow by 8.1 percent over the next seven years (2). ![]() The challenges are significant, so many companies choose to outsource their analytical testing. ![]() And beyond CQAs and CMAs may lie many additional variables – powder flowability, porosity and specific surface area, for example, depending on the pharmaceutical product type, can affect development and manufacturing and are, therefore, valuable to measure. The knowledge accrued is also helpful for ensuring secure optimization of the supply chain (1). Though potentially demanding, it facilitates a more flexible regulatory approach – an important consideration when putting together the robust submission package required. QbD places emphasis on process and product understanding, and is intended to reduce risk. How do you choose which properties to measure when it comes to characterizing APIs, excipients, or even the formulation? The identification of critical quality attributes (CQAs) and critical material attributes (CMAs) is an integral component of Quality by Design (QbD) but decisions around how best to measure them are not always easily made in-house. ![]()
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