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According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contractmanufacturing organisations (CMOs) to acquire facilities. Partnering with containment experts.
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. What is driving the surge in demand for APIs? This adds costs and time to the processes involved.
Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. In this ongoing series , we put a spotlight on contracts between pharma companies and contractmanufacturing organizations (CMOs).
It is worth noting that, any discrepancies encountered at this stage of manufacturing can lead to microbial contamination, subsequently resulting in loss of product, long development timelines and substantial financial burden for the drug developers, owing to the high cost of cell-derived raw materials.
Different Types of HPAPIs The new generation of APIs being developed are highly complex in nature, including peptides, HPAPIs, oligonucleotides and sterile APIs. This precaution is taken to prevent any potentially harmful contaminant from escaping the production area.
The focus of stakeholders has now shifted to optimizing the cell therapies manufacturing process. For instance, in case of an autologous cell therapy ; the first step involves the procurement of input material (cells) from the patient, since these therapies are developed using the patient’s own cells.
The two-hour event will cover various topics, including an overview of the Company’s board and executive leadership, its commitment to environment, social and governance (ESG) matters, and progress updates on the Company’s critical care programs, manufacturing and distribution approach, and commercial readiness plans. 28, 2021 11:00 UTC.
Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. 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.
to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-April 2021.
HPAPIs may now represent more than 30% of the drug development pipeline. Within that figure, GlobalData estimates that around 60% of pipeline HPAPIs are developed to target oncology. Manufacturing these highly potent and often cytotoxic drugs introduces many risks for operators and the environment. Free Whitepaper.
Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination. GlobalData’s Contract Small Molecule API Manufacturing Industry by the Numbers (2021) analyzed 2,787 small molecule API contractmanufacturing facilities.
Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. A robust manufacturing process that leads to a consistently high-quality product is a major business goal for pharmaceutical R&D.
– about the advantages and challenges of product lyophilization, developing lyophilization processes on site at their Bloomington, Indiana plant, and the importance of continuing research. Case in point: the recently developed mRNA-based therapeutics which require cold storage for stability.
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