Biopharmaceutical production is an often discussed application for single-use technologies, but single-use technologies also have application for small-scale finished drug-product manufacturing for producing clinical-trial materials. An educational webcast by Pharmaceutical Technology, “Accelerate Sterile and Non-Sterile Clinical Trial Manufacturing with Single-Use Technologies,” on Wednesday Mar. 6th examines this application. Read more »

In January, 2011, FDA released its guidance, Process Validation, General Principles and Practices, describing process validation practices based on quality-by-design principles. At the IBC Biopharmaceutical Development and Production conference held this week in Huntington Beach, California, scientists described how their companies have been working toward implementing the guidance for the production of biopharmaceuticals.
Vijay Chiruvolu, director of corporate validation at Amgen discussed his company’s current process validation practices. Amgen, he explained, was somewhat ahead of the game, having worked toward implementing a data-driven and risk-based approach to process validation before the guidance was finalized. For the past 10 years, Amgen has taken a lifecycle approach to process validation, by beginning to plan process validation strategies during the early phases of process design and by continuing to update the plan throughout the lifecycle of the product. Process validation, he explained, is not a once-and-done activity, but should be adjusted as process understanding improves over time, or as expected or unexpected process changes require additional validation.
Peter Calcott, president of Calcott Consulting, weighed in with what the guidance means for small companies. Big biotechs like Amgen can devote a lot of resources towards risk assessment, process understanding, and developing a risk-based process validation plan, but smaller entities that outsource some or all of their process development and manufacturing activities will likely not have the staff or knowledge necessary to implement the guidance on their own. Calcott said he is commonly asked how much effort a company should spend in implementing the new guidance, and his advice, he says, depends on what the company’s business model is and where in the development cycle they are. For example, companies in early stages of development that expect to sell the compound to a larger entity for development need not concern themselves with the guidance, with the expectation that process validation will fall to someone else. A company that expects to manufacture and perhaps market the compound itself, however, should invest the time and resources to develop a compliant process validation plan.

As fine-chemical producers, custom manufacturers, and pharmaceutical companies gathered this week for Informex in Anaheim, California, one observation stands out: for all the inroads that biologic-based drugs have made, the pharmaceutical industry remains a small-molecule marketplace. Read more »

At the end of February, sunny southern California will be the site for a week-long conference devoted to the development and production of biopharmaceuticals. Read more »

Continuous manufacturing is now becoming a trend as its advantages are being increasingly recognized. At the PDA/EMA joint conference, which took place earlier this month, Martin Wunderlich from F. Hoffmann-La Roche presented an industry case study on solid drug product manufacturing based on this concept. He explained how a continuous wet granulation process for one of the company’s product (referred to as ‘product X’ hereafter) was developed using a quality-by-design (QbD) approach and a control strategy based on process analytical technology (PAT), as well as the technical challenges involved in the development of the process. Read more »

On the second day of the PDA/EMA joint conference, we had a choice of three different topics, all running simultaneously: GMP inspection practice, process and validation, and challenges for EU harmonisation. I somehow found myself listening to Lina Ertle from the French national agency for medicines and health products (ANSM), who gave an update on process validation guidelines. Read more »

How to optimize continuous processing and make it work in pharmaceutical manufacturing is a crucial issue. Real-time devices for continuous feeding processes, among many other topics, were discussed at a seminar I attended last week. The seminar, “Advances in Pharmaceutical Processing”, was sponsored by K-Tron, which supplies material handling and feeding systems. Read more »

Last week, I attended the PDA/EMA joint conference in Cascais, Portugal. The topic was on compliance, a prerequisite for availability of medicinal products. The conference kicked off with a plenary session on the impact of the new falsified medicines directive (FMD) on regulators and the pharmaceutical industry. Belen Escribano Romero from the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), a public body that belongs to the Spanish Ministry of Health, provided an overview of the main changes in the new legislation, which included, amongst others, the importation of APIs and excipients from third-world countries, inspection planning, revisions of the GMP guidelines, new GDP guidelines for the distribution of medicinal products by wholesalers and brokers, as well as pending regulations relating to safety features and purchasing medicines via the internet. It is hoped that these additional requirements will increase the quality of medicinal products, reinforce supply-chain security and prevent penetration of counterfeits, and better protect those buying medicines online. Read more »

Want to know what the future of pharma science looks like? AAPS knows. They recently awarded several graduate students for their work in research and development, pharma analysis, drug delivery, bio- and nano-technology, and more. PharmTech had the chance to talk with some of the winners and their stories appear in the December issue of PharmTech. You can get a sneak preview of the students’ winning research via a video podcast on PharmTech.com and the PharmTech Player.

Student Innovation Across the Pharma Sciences