Tuesday, April 23, 2019 Daily Archives

A Harmonized Approach to Data Integrity

Data integrity is achievable when data collection is complete, consistent, and accurate (1). Failure to maintain data integrity compromises a company’s ability to demonstrate the safety and efficacy of its products. Escalation of serious regulatory actions related to data integrity violations has prompted the need to assess data integrity compliance and implement systems designed to guarantee it. Comprehensive measures must be taken to ensure that data are attributable, legible, contemporaneous, original, and accurate (ALCOA) (2). Preventive measures need to be…

Opportunities for Modern Robotics in Biologics Manufacturing

It should come as no surprise to anyone familiar with biomanufacturing that current designs of bioprocess facilities as well as associated manufacturing spaces and support operations require excessive amounts of manual labor and manual interventions that lead to high labor costs and, consequently, total cost to supply. From receipt of raw materials to process execution and performance review, resolution of quality issues, and product shipping, no industry devotes a greater percentage of operating costs (or cost of goods sold, CoGS)…

Determining Control Chart Limits for Continued Process Verification with Autocorrelated Data

Control charts are used to assist in process monitoring activities. They use an estimate of central tendency (the overall mean) and variation (the standard deviation). Sample standard deviations (S) tend to underestimate process standard deviations (σ) when they are calculated using limited sample sizes of independent results (1). For this reason, the unbiasing constant c4 is used as a divisor when calculating Shewhart control-chart limits. If data used for control charting are positively autocorrelated, that tends to underestimate σ further…

GSK expects normal HPV vaccine supply to resume in June

Manufacturing constraints have led to supply issues concerning GlaxoSmithKline’s HPV vaccine, Cervarix, which are set to continue until June. In a letter sent to French health professionals last month, GlaxoSmithKline (GSK) reported supply issues regarding its product Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant affecting the first half of this year. According to the letter, published by the French authorities the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week, the shortage…

Danaher’s bioprocess biz bright with China and GE on horizon

With continued double-digit growth in China and the future addition of GE Healthcare’s Biopharma business, Danaher Corporation is poised to strengthen its position in the bioprocess space. Danaher Corporation reported a robust first quarter last week, with 4% year-on-year sales growth across all businesses to $4.9 billion (€4.4 billion). Core revenue from Life Sciences grew 7%, which included contributions from Pall Corporation, a major vendor in the bioprocess space. The firm does not report financials from its individual businesses. “In…