Entries by [email protected]

How Biotech Startups Can Scale Logistics Efficiently

Biotech startups are often laser-focused on scientific innovation – developing a novel therapy or diagnostic that could change lives. However, as these startups progress from R&D to clinical trials and ultimately to commercialization, logistics and supply chain management become critical factors for success. Efficiently scaling logistics is a common hurdle: early-stage companies may not have […]

Best Practices for cGMP-Compliant Storage and Temperature-Sensitive Shipping

In the pharmaceutical and biotech industries, maintaining product quality isn’t just about how drugs are manufactured – it’s equally about how they are stored and shipped. Many of today’s medicines, especially biologics, vaccines, and cell/gene therapies, are sensitive to environmental conditions. Any deviation from required storage temperatures or handling procedures can degrade a drug’s efficacy […]

New U.S. Steel and Aluminum Tariffs Shake Global Trade: What Businesses Need to Know

Introduction The global trade landscape shifted dramatically on March 12, 2025, when the United States reinstated a 25% tariff on all imported steel and aluminum, extending duties to hundreds of downstream products. The move, aimed at strengthening American manufacturing, has already sparked swift retaliatory action from key trading partners, including Canada and the European Union […]

The Future of Biologic Drug Cold Chain Management

Biologic medicines – from vaccines and insulin to advanced cell and gene therapies – are often temperature-sensitive and require strict cold chain management. In recent years, the rise of biologics has brought new challenges in storing and transporting these fragile products, especially those needing ultra-cold conditions. Looking ahead, cold chain management for biologic drugs is […]

Third-Party Satellite Facilities – Mitigating CDMO Risks

Introduction In the fast-evolving landscape of pharmaceutical manufacturing, Contract Development and Manufacturing Organizations (CDMOs) have become essential partners for drug companies, providing outsourced services from drug development to full-scale production. However, relying solely on CDMOs comes with inherent risks, such as supply chain disruptions, capacity constraints, and quality control issues, which can compromise the timely […]

Expanding Horizons: Big Pharma’s Strategic Shift to Emerging Markets

Introduction As the pharmaceutical landscape faces slowing growth in traditional strongholds, major pharmaceutical companies are turning their focus towards emerging markets. Countries like India, China, and Brazil are witnessing significant investments from Big Pharma, driven by the need to tap into these rapidly growing economies. According to IQVIA data, between 2016 and 2021, the pharmaceutical […]

The Rising Role of CDMOs in Pharmaceutical Manufacturing in the USA: Addressing the Need for Third-Party Satellite Facilities to Support Materials Management

Executive Summary In recent years, the Contract Development and Manufacturing Organization (CDMO) industry has experienced substantial growth, particularly in the United States, driven by the increasing complexity of drug development and the need for cost-efficient, scalable manufacturing solutions. As pharmaceutical companies focus on their core competencies, outsourcing production to CDMOs has become a strategic imperative. […]

The Strategic Need for Third-Party Satellite Facilities in U.S. CDMO Operations

Introduction The Contract Development and Manufacturing Organization (CDMO) sector has become a critical player in the U.S. pharmaceutical industry, particularly as companies increasingly outsource drug development and manufacturing to focus on core competencies. With the rise of advanced therapeutics, such as cell and gene therapies, and the ongoing pressures of a post-pandemic market, CDMOs face […]

The Impact of Big Pharma’s R&D Cutbacks: A Shifting Landscape for Innovation

The pharmaceutical industry has long been a beacon of innovation, with research and development (R&D) at its core. However, recent trends indicate a significant shift in how major pharmaceutical companies are approaching their R&D investments. The ramifications of these changes may change the future of drug discovery and development. The Current Landscape The COVID-19 pandemic […]

Top 5 Factors Affecting the Life Sciences Industry in 2024

The life sciences industry is being shaped by technological advancements, regulatory changes, and evolving market conditions. Here are the top-5 factors influencing the sector: 1. Finding Capital Investment Securing capital remains a critical challenge for life sciences companies, especially startups and early-stage ventures, due to market volatility and regulatory uncertainties. Despite this, there is still […]