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4 weeks ago | 
contractpharma.com | Tim Wright
The Drug Supply Chain Security Act (DSCSA), established in 2013, set a foundation for tracking and verifying pharmaceutical products across the United States. However, while the regulations have been phased in for over a decade, its regulatory requirements continue to evolve, introducing new challenges for the industry.
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4 weeks ago | 
contractpharma.com | Tim Wright
Patient-centric innovation is reshaping our industry, with its influence extending beyond formulations to encompass thoughtful packaging design. This holistic approach aligns with evolving consumer expectations—today’s patients demand medications and supplements that are not only effective and safe, but also convenient and quick to use.
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4 weeks ago | 
contractpharma.com | Tim Wright
The fill-finish stage of pharmaceutical manufacturing may not make headlines, but it is the final crucial step—the point where all the work behind a new drug either comes together or falls apart due to contamination, inefficiencies, or regulatory setbacks. Right now, the demand for high-quality, adaptable fill-finish services is soaring.
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1 month ago | 
contractpharma.com | Tim Wright
In today’s evolving pharmaceutical environment, the fill‐finish segment stands out as a critical linchpin connecting drug development with successful patient delivery. Driven by seismic shifts in global health trends, an evolving therapeutic landscape, and breakthroughs in manufacturing technology, fill‐finish outsourcing is undergoing a transformation unlike any seen before.
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2 months ago | 
contractpharma.com | Tim Wright
In the pharmaceutical sector, contract development and manufacturing organizations (CDMOs) play a vital role in advancing healthcare by facilitating drug research, development, and production. However, managing extensive sensitive information comes with unique cybersecurity and compliance challenges. The threat landscape is increasingly perilous, with data breaches on the rise and stringent regulatory demands that CDMOs must meet to safeguard intellectual property and comply with global standards.
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2 months ago | 
contractpharma.com | Tim Wright
Recent surveys suggest that as many as one-fifth to one-third of participants drop out of clinical studies.1,2 Certainly, precarious patient health is a contributing factor to such poor retention, as is misalignment on inclusion criteria. But those aren’t the only barriers to patient retention. Quite simply, too many patients find it too difficult to participate in clinical trials. As healthcare technologists, we assume a heavy responsibility for making clinical trial participation less burdensome.
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2 months ago | 
contractpharma.com | Tim Wright
Continuous manufacturing (CM) has become a contentious topic in the modern pharmaceutical lexicon, driven by divergent definitions—from perfusion and flow chemistry to fully integrated systems. In biologics production, CM is an emerging technology aimed at improving yields, reducing costs, and streamlining production processes. However, despite its recent media attention, misconceptions remain about what constitutes true continuous manufacturing in biologics production.
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2 months ago | 
contractpharma.com | Tim Wright
The launch of HUMIRA (adalimumab) as a single-dose prefilled syringe (PFS) in 2003 marked the start of a revolution in the delivery of vial-based biological products.
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2 months ago | 
contractpharma.com | Tim Wright
Intensifying competition and pricing pressures in the pharmaceutical industry are placing demand on developers and manufacturers to explore innovative pathways to differentiate their products and create value, particularly in the generic drug market. As a result, many pharma companies are turning their focus to value-added medicines (VAMs) to achieve differentiation.
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2 months ago | 
contractpharma.com | Tim Wright
Last fall marked 25 years(!) since I entered the CMO sector, before it even had a “D” and became CDMO. I helped launch Contract Pharma magazine as its founding editor in the fall of 1999, and almost 15 years later I left that role to launch the Pharma & Biopharma Outsourcing Association (PBOA) so I could help CMO/CDMOs work with regulators and legislators, and better understand their peers in the industry.
