The first article in this series discussed the physical elements of facility design that sponsors look for in contract development and manufacturing organizations’ (CDMOs) manufacturing facilities. This second installment describes sponsors’ requirements for dedicating equipment to GMP operations, equipment redundancy, and transparency of equipment and facility issues.
The ongoing Brexit negotiations between the British Parliament and the EU has left pharma supply chain managers scrambling for cover. As recently as October 2018, the probability of a no-deal scenario was low and it made little sense to invest in or commit to alternate plans, but this changed when Parliament rejected Prime Minister Theresa May's deal in December. The politics are not as important to business as the conclusion: The best way to mitigate disruption is to more heavily weigh finding alternate ex-U.K. suppliers versus waiting it out. Negotiating deals and supply agreements takes time, as does the logistics of tech transfer and moving materials. So risk management, timing, and terms are key success factors.
ISR data, collected for the purpose of improving our understanding of the much-anticipated bioprocessing capacity crunch, reveals that it is not a matter of if or when a capacity crunch will impact the biopharmaceutical industry; instead, it’s a question of who, or which types of drug innovators, will be impacted.
A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.
Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.
“Skinny labeling” refers to the practice of follow-on drug manufacturers seeking approval for some but not all the indications for which the branded drug has been approved. In the small molecule drug world, it has been a successful strategy for generic drug makers to get around the brand’s follow-on “new use” patents that keep the brand from falling off the “patent cliff” long after the expiration of the original patents. This strategy is starting to be used in the biosimilar realm.
We like simplicity. Yet in pharmaceutical operations we have become very good at making things more complex than they need to be. This article illustrates a few areas where companies tend to make matters worse and highlights areas where both industry and regulatory agency leaders should push back and focus on simplification.
Patient-centricity. Patient at the center. Voice of the patient. The pharmaceutical/biotech industry frequently uses these phrases when discussing the inclusion of patients and caregivers in clinical trial development. I used them when I was in the pharmaceutical industry, and they meant something to my R&D diversity and patient engagement team. We believed bringing patient and caregiver insights, experiences, and opinions into the drug development process was paramount. Without them, we wouldn’t understand their priorities and obstacles.
This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This allows manufacturers and sponsors to identify new trends in the focus of FDA inspectors and to act to address or justify similar situations at their own firms.
Most in the life sciences agree that artificial intelligence (AI) will reshape the sector from R&D through commercial. Although AI has only just left the starting gate and most activity is in exploratory phases, some benefits are starting to emerge. And there are pockets of early adopters trailblazing new approaches and seeking a competitive edge to accelerate products to market, improve patient outcomes and care, and drive cost efficiencies.
|
|
|
|
|
|
|
|
|