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Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.
Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. This suggests a move towards high-value specialised manufacturing. What is driving the surge in demand for APIs?
These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.
Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drugmanufacturers across the globe.
Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drugmanufacturers or sponsors during 2023, with 161 issued in calendar year 2022.
Considering the vast potential of cell therapies in the treatment of rare disorders and sufficient body of evidence validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, cell therapies have garnered considerable attention of players engaged in the healthcare industry, in the past few years.
drug development initiative from 2012 to February 2019. Shah previously served as Chief Executive Officer and a member of the board of directors of BioMotiv, an accelerator company aligned with the Harrington Project for Discovery & Development, a U.S.
AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses. . Emergent claims however that one batch of the vaccine simply failed quality controls, and no contamination took place.
billion, primarily driven by Pfizer CentreOne, Pfizer’s contractmanufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2021. Pipeline Developments.
Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. HPAPIs may now represent more than 30% of the drug development pipeline. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.
The number of high-potency drug approvals has increased over the last decade, driven by the increasing use of APIs (Active Pharmaceutical Ingredients) in the pipeline and among marketed drugs. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.
Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. This prevents contamination of the elements by the sampled powder. For more information download the paper below.
PM: Lyophilization is widely used in the pharmaceutical and biotech industry for small molecule drug products, vaccines, antibodies, and other biological material. For more information about how Baxter BioPharma Solutions manufacturing expertise can support your project, dow nload the paper below. . Free eBook. United Kingdom.
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