News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
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The demand for biologic drugs continues to grow at a steady 12–14% annually. To keep up, biotech and biopharma developers are increasingly relying on outsourcing partners to meet both clinical and commercial research, development, and production needs.
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Starting with the end in mind when choosing mRNA raw materials help mitigate costly risks. Seeking quality attributes that go beyond GMP grade is key.
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The biopharmaceutical industry has grown enormously in recent decades, yet the high cost of biologics and their global accessibility continues to be a major challenge.
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Implementing safe handling of commercial AAVs vector manufacturing bear challenges. But there are process solutions to cope with scalable production of viral vectors.
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The COVID-19 pandemic emerged at a time when the clinical trial landscape had reached a peak in complexity. Global trials are now commonplace as drug makers seek to establish efficacy in diverse populations.
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The world urgently needs new manufacturing capabilities to realise the huge potential of genome editing therapy. Equipped with CRISPR-Cas9 technology, researchers have revealed opportunities to address major unmet medical needs through genome editing and...
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With 21 facilities located globally and 260,000 ft2 of total capacity, Yourway is dedicated to transporting temperature-controlled clinical trial materials, including ancillary supplies, around the world within mere hours.
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Meeting microbiological standards is extremely hard without an environment that speaks to cleanliness: ultimately facilities don’t get compliant, they stay compliant.
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Sterility testing is a crucial element of pharmaceutical manufacturing but testing for the absence of objectionable organisms in finished products is just the tip of the iceberg. Find out more
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Flexibility has become a necessity in clinical trials. The trend of decentralization is a significant change for the industry and has grown increasingly common. While certain treatment or assessment visits still need to occur at the investigators’...
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When United States Pharmacopeia 60 (USP 60) came into effect little more than a year ago, it added a new dimension to testing for objectionable organisms in pharmaceutical products. The regulation, which was triggered by a string of Burkholderia...
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An investigation was recently conducted in Italy on around 200 post-Covid patients suffering from persistent fatigue, who were advised to take Apportal for 28 days
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The pandemic remains a globally disruptive entity that can impede efficacy of clinical trials. Choosing the right partner helps you concentrate on obtaining optimal results from at-home populations.
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The ongoing pandemic has altered the face of human clinical trial execution, stimulating the adoption of decentralized/virtual trials. Here’s how to ensure success with your trial.
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The virtual pharma business model has gradually become a popular alternative to traditional pharma. As an integrated service provider, Yourway offers the logistical support from study design to packaging needed by virtual and small companies entering...
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Supporting the delivery of clinical trial materials requires more than a logistics service provider. Clinical trials are growing in number and complexity. More trials are dispersed over many locations in different countries of the world with varying...
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Samsung BioLogics has moved quickly since it began operating in 2011. The South Korean contract development and manufacturing organization (CDMO) has built a series of progressively larger, more advanced facilities, culminating in its 180,000L “Dream...
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Moving cell and gene therapies from a clinical to commercial setting requires a transformation of the traditional supply chain model. World Courier explores the considerations for therapy owners.
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Personalized medicines require a personalized supply chain. Find out more from World Courier.
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Clinical trials have evolved and traditional models are becoming extinct. Read about the change and World Courier and MRN's patient-centric approach.
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Getting a clinical trial drug into China is a complex business. Any discrepancies in paperwork or the physical shipment can lead to delays at customs or China Inspection & Quarantine. World Courier shares its experience for successful shipping.
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There was a time when scientists had to pass by their lab during weekends. They had to break off personal activities to monitor cell proliferation and viability in the laboratory. Automation has changed this way of working and the scientistsdo not need...