Quality is of utmost importance in drug development and manufacturing. The increased globalization of the pharmaceutical and biopharmaceutical industries, resulting in more complex and elongated supply chains on a raw material and ingredients basis, obligates suppliers and pharmaceutical and biopharmaceutical companies to develop ways to achieve greater transparency and understanding of those supply chains to ensure product quality and regulatory compliance. Read more »
It is well known that the pharmaceutical industry spends billions each year on promoting their products, especially to healthcare professionals. In the US, a significant amount is also spent on direct advertising to consumers. In a report by the FDA on Keeping Drug Advertising Honest and Balanced, Thomas Abrams, director of the Office of Prescription Drug Promotion (OPDP), shares on how the agency “protects consumers from false and misleading ads for prescription drugs that appear on TV, radio, online and in print publications.” Read more »
International markets play an important role in pharmaceutical and biopharmaceutical companies’ growth strategies, and it is crucial that companies meet the challenge of global regulatory compliance. Optimizing a quality management system to ensure regulatory and corporate compliance for product registrations for new and existing drugs in new geographic markets is essential for commercial success. Pharmaceutical Technology will examine the operational, organizational, and technological-based requirements on how to reduce risk and achieve operational efficiency for global product registrations in a live webcast on Tuesday June 11 from 2:00 to 3:00 PM EST. Read more »
The US Food and Drug Administration and industry have been working to incorporate process validation as an integral component of drug development and production, and to avoid divergent policies in the US and Europe. A good deal of progress has been made in this area, but manufacturers continue to feel uncertain about the details in revising existing systems and updating long-held practices to fit new approaches, as seen in the discussion at the PDA/FDA Process Validation Workshop in Bethesda, Md., May 20-21. Participants assessed FDA’s Process Validation guidance, which was published in January 2011, and the corresponding PDA technical report on “A Lifecycle Approach to Process Validation” (TR 60) issued in January 2013 [available at www.PDA.org].
The aim is to help manufacturers who are wrestling with and working to implement the FDA guidance, explained Harold Baseman, chief operating office of ValSource and co-chair of the PDA process validation interest group. The workshop program followed FDA’s three stages for process validation, starting with process design and moving through process qualification to achieve continued process validation to provide ongoing assurance that a production process remains in a state of control.
Workshop attendees discussed the importance of gaining extensive knowledge about a process early in design and development stages to ensure that the system is well controlled. Patrick Swan, deputy director of the Division of Monoclonal Antibodies, Office of Biotechnology Products (OBP) in the Center for Drug Evaluation and Research (CDER), highlighted the value of tapping prior knowledge to support process validation activities, noting that this may expedite product development for lifesaving breakthrough therapies.
Process qualification involves identifying and interpreting information from process design functions to establish testing and acceptance criteria. Methods for equipment and facility assessment are important, as are sound process qualification sampling plans.
The lifecycle approach also involves linking process validation activities to a manufacturer’s Quality Risk Management system. While manufacturers and regulators are looking to shift away from assessing a set number of batches, questions remain about how much data is needed to show that something is or is not in control, Baseman explained.
Similar efforts by the European Medicines Agency (EMA) to update policies on these issues were discussed, with an emphasis on the importance of achieving similar approaches to validation requirements. Concerns were raised that EMA doesn’t consider process development part of process validation, that different terms are emerging, and that divergent regulatory approaches may cause confusion. Manufacturers filing applications in some 150 countries emphasized the importance of common formats and systems.
OBP deputy director Jeffrey Baker explained that FDA and EMA officials discuss these and other issues at “cluster meetings,” held to address topics such as biosimilar evaluation, good manufacturing practices and differences in review policies. Regulatory authorities at these sessions don’t consider specific companies or applications, Baker noted, but address general policy approaches, with an eye to gaining alignment on regulatory guidance.
Baker and others suggested that questions about data collection and regulatory requirements can be addressed by focusing on the science, which is key to appropriate terminology, data formats and determining what information is needed to assure product quality.
Yet, legacy products raise challenges, as manufacturers have to determine what would be involved in updating process validation data to support manufacturing changes or address safety issues.
One benefit of revised process validation policy that reduces the volume of unnecessary testing is to streamline the development and approval of important, life-saving therapies. Future FDA guidance on its regulatory approach to “breakthrough” therapies should explain further how the agency will address manufacturing and quality assurance issues for such products, Baker noted. But he pointed out that companies request the breakthrough designation and thus should be able to explain how they will supply a quality product efficiently and quickly for sick patients.
The issue of patients not receiving essential medicines because they cannot afford them is becoming a serious problem in the EU as the region battles through its economic crisis. In a briefing by the European Public Health Alliance (EPHA) on Access to Medicines in Europe in Times of Austerity, it was highlighted that the three factors that will determine whether or not a patient gets his/her medicine are “affordability and availability, in terms of access to medicines, and innovation in terms of developing new methods of assuring best possible health outcomes.” Read more »
FDA’s quality-by-design (QbD) initiative is a systematic approach to designing and developing pharmaceutical formulations and manufacturing processes to ensure predefined product quality. Understanding the critical quality attributes of the ingredients in a formulation, including excipients, and the critical process parameters in the manufacturing process of the finished drug product is crucial for successfully implementing QbD. Pharmaceutical Technology will be holding a live webcast on Thursday May 23 from 10:00 AM to 11:00 AM EST to examine the regulatory and technical considerations in implementing QbD for coatings in modified-release formulations, including strategies to mitigate the risks associated with alcohol-induced dose-dumping and the application of alcohol-resistant coatings. Read more »
The global market for biosimilar drugs has been forecasted to be worth $2.445 billion this year, according to a new report by British market research specialist Visiongain. The growth represents a 20% increase from last year and accounts for approximately 2% of the overall biologics market. Moreover, the global biosimilars market is expected to experience a steady growth over the next 10 years, driven by worldwide launches of such products, particularly in the EU and US. Read more »
Evidence of health outcomes is what payers want to see. As a result, biotech companies are now focussing more on demonstrating economic value, for example, by showing survival benefit of a cancer drug or superiority to branded or generic competitors. Read more »
Guest blog written by Chris Watson, product manager of Exco InTouch.
AstraZeneca and Exco InTouch have announced a program to develop and launch interactive mobile phone and internet-based health tools that will help patients in the UK and their healthcare providers to track and manage chronic conditions. AstraZeneca’s R&D organisation and Exco InTouch are developing the tool with an initial focus on chronic obstructive pulmonary disease (COPD). Read more »
As pharmaceutical and biopharmaceutical companies intensify product development in biologics, they are tasked with meeting the challenges of biologic-based drug development and manufacturing. Unlike traditional small-molecule drugs, stability studies for biopharmaceuticals can be one of the most critical and challenging aspects of large-molecule drug development. The size and complexity of most proteins provide fertile ground for intramolecular changes and multiple routes of degradation, and to assess their effects, each must be correlated to the bioactivity of the drug. Pharmaceutical Technology will examine biopharmaceutical stability studies in more depth by gaining input from leading industry experts, in a live webcast, “New Strategies for Biopharmaceutical Stability Testing,” on Thursday May 9th from 2:00 to 3:00 PM EST. Read more »