Drug Product


Viewing related articles

Lyophilization: An industry perspective on the application of modeling to lyophilization process scale up and transfer

While freeze-drying modeling is well established and documented, the extent of its application to routine operations, including development and manufacture, has not yet been fully realized. A survey, conducted by BioPhorum, revealed that only a few companies use modeling for scale up and transfer. For the last year, the collaboration has been combining individual company efforts with the aim of harmonizing best practices and helping to define minimum regulatory standards. This paper outlines different applications of modeling to freeze-drying of biopharmaceutical products at commercial scale. It also signals the intent of the BioPhorum to champion a wider adoption, and realize the full potential of modeling across the industry to standardize lyophilization practices, accelerate technology transfers and optimize operational performance

read more

QC best practice: QC Labs best practice navigator

QC labs in biomanufacturing facilities are complex high throughput operations, that the manufacturing facility is totally dependant on for analysis and release of batches.  In many ways QC labs and their support services are more like conventional ‘factories’ than the operations that they support in terms of processing volumes flows and human interventions.  As such an optimized stable and effective lab operation can only really be achieve with the application of appropriate manufacturing best practices practices. But once developed it will deliver significant improvements for the entire manufacturing operation. This ‘Members Only’ navigation tool guides you to a comprehensive range of operational best practices that have been proven and validated in the industry to deliver highly lean and effective QC lab operations. 

read more

Container closure integrity (CCI): Response to the publication of USP<1207>

USP published its revised and expanded guidance, USP<1207>, in 2016 ostensibly asking as many questions as it answered.

Specifically, USP<1207> implies ’probabilistic’ tests such as the ubiquitous dye ingress method are inferior and proposes a preference for so-called deterministic tests. The added assertions that deterministic methods can achieve high levels of sensitivity and accuracy do not reflect the ‘real world’ experience of the industry’s CCI experts whose work with the newer methods highlight a range of improvements that must be addressed before such claims can feature in guidance.

This paper makes the distinction that any method – probabilistic or deterministic – when properly validated may be regarded as acceptable, with no one method type worthy of a preferred status

read more

Product changeovers (PCO): Methodology for assessing product inactivation during cleaning part II: setting acceptance limits of biopharmaceutical product carryover for equipment cleaning

For multi-product biopharmaceutical facilities, setting the acceptable level of process residues following equipment cleaning is an important regulatory, business, product quality, and patient safety consideration. Conventional approaches for setting an acceptance limit for process residues have been based on the assumption that the active pharmaceutical ingredient (API) is chemically or functionally intact following the cleaning process. These approaches include Maximum Allowable Carryover (MAC) Health Based Exposure Limits and other “dose” or Permissible Daily Exposure (PDE)-based limits. The concept for cleaning acceptance limits based on intact product originated from the manufacturing of small molecule pharmaceuticals (1). In contrast biopharmaceutical products are large molecules that are likely to degrade and become inactive when exposed to cleaning conditions. Therefore, an alternative approach to setting cleaning acceptance limits for biopharmaceutical products based on the actual process residues that could potentially be present on production equipment should be considered. In this paper alternative approaches for setting acceptable levels of process residue are described building upon the basis that API inactivation by the cleaning process has been demonstrated.

read more

Product changeovers (PCO): Acceptance Limits for the carryover of inactivated API Part I – The comparable quality approach

For multi-product biopharmaceutical facilities, setting the acceptable level of process residues following equipment cleaning is an important regulatory, business, product quality, and patient safety consideration. Conventional approaches for setting an acceptance limit for process residues have been based on the assumption that the active pharmaceutical ingredient (API) is chemically or functionally intact following the cleaning process. These approaches include Maximum Allowable Carryover (MAC) Health Based Exposure Limits and other “dose” or Permissible Daily Exposure (PDE)-based limits. The concept for cleaning acceptance limits based on intact product originated from the manufacturing of small molecule pharmaceuticals. In contrast biopharmaceutical products are large molecules that are likely to degrade and become inactive when exposed to cleaning conditions. Therefore, an alternative approach to setting cleaning acceptance limits for biopharmaceutical products based on the actual process residues that could potentially be present on production equipment should be considered. This paper, describes the methodology to assess and verify API inactivation during cleaning

read more

Reliability: Misconceptions of maintenance and reliability – a biopharmaceutical industry survival guide

Run a Google search on ‘Maintenance Excellence and Reliability Engineering’ will get an indication how prominent the subject has become within the corporate agenda. This is particularly true of the biopharmaceutical industry where such concepts are becoming more widely adopted in attempts to reduce risk and costs. While leaders are pressing for wider adoption, organizations are often slow to adopt because many of the concepts are counter-cultural. Reliability Engineers spearheading the change find themselves constantly challenging existing mindsets, having to educate the non-believers by introducing sound reliability concepts. Across a large organization this becomes a difficult and time-consuming task. This brief Survival Guide, goes back to basics, focuses on common misconceptions and introduces the key concepts behind Reliability Engineering.

read more