July 7, 2023
As a supply chain expert in the biotech and pharmaceutical industry, I understand the unique challenges faced by companies operating in this highly regulated and complex sector. Supply chain management is critical for ensuring products are manufactured, transported, and distributed safely and efficiently while maintaining compliance with regulatory guidelines. In […]
June 10, 2023
On April 12, 2023, BeNeLuxA1 announced that negotiations failed to secure reimbursement for Libmeldy, a gene therapy developed by Orchard Therapeutics for the treatment of metachromatic leukodystrophy, on grounds of price. In the UK, an initial application to NICE was rejected as well back in 2020. This is a huge […]
May 13, 2023
Identifying critical process parameters (CPPs) is essential for ensuring the quality, safety and efficacy of pharmaceutical products. Critical process parameters are the key input variables that can affect the quality and consistency of a product. Failure to appropriately control these parameters can result in production failures, batch rejections and product […]
May 4, 2023
Diagnosing illnesses and monitoring health is increasingly reliant on utilizing software. For patients, manufacturers must maintain standards and regulations. Companies can be concerned with challenges concerning updated legislation such as the EU’s MDR. Companies have increased importance on determining whether their software is categorized as a medical device, as well […]
March 22, 2023
The Biomedical Advanced Research and Development Authority (BARDA) is) probably best known for its role in Operation Warp Speed and subsequent efforts to accelerate the manufacturing of COVID-19 vaccines. BARDA, formed in 2006, anticipated threats such as the COVID-19 pandemic. BARDA’s mission is to develop the necessary response measures to […]
February 27, 2023
When pharmaceutical companies develop a new drug product for the market, there are many different steps a potential product must go through to determine and control its safety, manufacturability, effectiveness and reliability. These processes, and all activities within, are known as chemistry, manufacturing, and controls (CMC). CMC is done during […]
