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Process and plasmid design optimization, disposable equipment, and flexible platform processes all play important roles.
Decreasing vein to vein time saves lives.
There is growing pressure for robust and economically scalable viral-vector manufacturing technologies.
Shifts in pharmaceutical packaging have spurred tremendous growth in the pre-filled syringe fill/finish industry.
Considerable efforts have been made over the years to resolve the key issues of stability and delivery of RNA-based therapeutics.
The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.
The trends shaping the growth of the biologics outsourcing industry demand attention.
March 16, 2023
Pfizer will acquire all outstanding shares of Seagen for a total of $43 billion.
27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation.
March 15, 2023
Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.
A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.
This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) , and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
Organizations can better understand the maturity of AI-driven automation technology across their organization’s IT landscape through effective pharmacovigilance.
This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.
Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.
March 14, 2023
FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.
Sumitovant Bipharma has completed its acquisition of Myovant Sciences for approximately $1.7 billion.
March 13, 2023
Silicon Valley Bank has collapsed, leaving many biotechnology companies unsure of the future.
March 10, 2023
Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.