Business

eBook: Quality By Design for Monoclonal Antibodies — Establishing the Foundations for Process Development, Design Space, and Process Control Strategies

The quality by design (QbD) modernized approach to pharmaceutical development is intended to provide regulatory flexibility, increased development and manufacturing efficiency, and greater room to innovate as well as improve manufacturing processes within defined ranges without obtaining regulatory approval first. QbD is a systematic developmental approach that starts with a clear goal in mind and emphasizes understanding of how variability in both process and materials affects a final product (1). Historically, product quality has been assured either with end-product testing…

Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry

Analytical method transfers are essential components of the current global biotechnology environment. Analytical method transfer can be defined as “a documented process that qualifies a laboratory (the receiving laboratory) to use a validated analytical test procedure that originated in another laboratory (sending laboratory), thus ensuring that the receiving laboratory has the procedural knowledge and ability to perform the transferred analytical procedure as intended” (1). The goal is to ensure that a method continues to perform in the validated state regardless…

Demand for Capacity Drives China’s Biomanufacturing Expansion

Over the past year, most of China’s biomanufacturing facilities have been engaged in active facility expansion. Based on our research of facilities under active construction, that growth has expanded total capacity in China by over 10%. Our research updates the Top 60 Biopharmaceutical Manufacturers in China directory from BioPlan Associates (1) and shows a continuing increase in new bioprocess capacity. This trend is unlikely to abate. As well as contacting our top 60 biomanufacturers, in fact, we contacted a number…

Host-Cell Protein Risk Management and Control During Bioprocess Development: A Consolidated Biotech Industry Review, Part 2

Even with increased understanding of host cell proteins (HCPs) and their potential risks, no practical approach has been made available for HCP risk management during bioprocess development. A BioPhorum Development Group (BPDG) team has identified common HCP-related risk factors and built a template for semiquantitative risk assessment during process development based on publicly available information. To this end, the BPDG HCP working team’s assay and knowledge-sharing experts have established a common HCP risk assessment tool and mitigation strategy to guide…

Statistical Properties of WECO Rule Combinations Through Simulations

The practice of quality control is promoted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). A number of process control charts are used in many biopharmaceutical companies to increase production and lower process costs. Here we focus on performance of three commonly used control charts: Shewhart control charts with WECO and supplementary rules, monitoring charts with exponentially weighted moving average (EWMA), and cumulative sum (CUSUM) charts. WECO rules got the name from a quality control…

Innovators and Biosimilar Companies: Experts Predict Intense Conflicts Ahead

CPhI Worldwide (organized by UBM) announced last fall the final section findings of the fifth edition of the CPhI Annual Report. Presented live at the meeting in Frankfurt, Germany, the report is now available online. It highlights immediate and long-term trends in pharmaceutical data, regulation, generics, and biosimilars. Four experts gave their views. They warned that the US Food and Drug Administration’s (FDA) approach to achieving six-sigma (nearly perfect or 99.9997% defect-free) quality is failing in respect to the pharmaceutical…

eBook: SUStainability — Concerning Single-Use Systems and the Environment

Disposable materials have been used in many aspects of biomanufacturing since muromonab was first launched in 1986. Single-use stirred-tank bioreactors first became commercially available from HyClone in 2004 (1). Despite their demonstrated value to bioprocessing, disposable materials remain the subject of wide-ranging differences of opinion. Discussions of any technology are healthy and important for identifying areas for improvement, but some hearsay and bold propositions made regarding single-use components and the environment are not always helpful. Sustainability is an important and…

Host-Cell Protein Risk Management and Control During Bioprocess Development: A Consolidated Biotech Industry Review, Part 1

Host-cell proteins (HCPs) constitute a significant class of process-related impurities during biologics manufacturing. Due to their potential impact on product quality and efficacy as well as patient safety, the total amount of residual HCP in a biological drug substance generally is considered a critical quality attribute (CQA) that usually needs to be tested for during batch release (1, 2). It is both an “industrywide” common understanding and a regulatory requirement to remove HCPs from biologics to acceptably low levels that…

eBook: The Commercial Expression Systems Market — What Has Changed in the Past Decade

A decade ago, BioPlan Associates prepared the findings of its 2008 directory of expression system technologies that were being promoted or considered likely to be suitable for commercial licensing for biopharmaceutical manufacturing (1). Due in part to the relatively slow advances in this critical area of bioprocessing, this study remains perhaps the only directory of biopharmaceutical-relevant expression systems available for licensing. Here I discuss aspects of related bioprocessing technologies that have and have not changed in the past decade. Expression…

eBook: Production of Cell-Line Development and Control of Product Consistency During Cultivation — Myths, Risks, and Best Practices

Health authorities are requesting substantial details from sponsors regarding practices used to generate production cell lines for recombinant DNA–(rDNA) derived biopharmaceuticals. Authorities also are asking for information about the clonality of master cell banks (MCBs) and control strategies to minimize genetic heterogeneity. Such requests are prompted by recent reports indicating “nonclonality” for certain production cell lines. To address these and related issues, the CASSS CMC Strategy Forum on “Production Cell Line Development and Control of Product Consistency During Cell Cultivation:…