Business

Raw Material Control Strategies for Bioprocesses

The 15th WCBP CMC Strategy Forum, “Raw Material Control Strategies for Bioprocesses,” met on Sunday, 11 January 2009 in San Francisco, CA. This forum considered the design and implementation of control strategies for complex raw materials used in bioprocessing. Discussion focused on key approaches and application of risk assessment tools that can be used to identify and assist in mitigating potential safety and efficacy concerns that can affect the quality of biological products. Two Sessions To fully explore the topic,…

Multiproduct Facility Design and Control for Biologics: Challenges and Considerations

Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans. A Chemistry, Manufacturing, and Controls (CMC) Strategy forum was held in Bethesda, MD, in August 2011 to highlight various challenges, risks, and control strategies associated with multiproduct facilities. Multiproduct strategies for the manufacture of a variety of…

Drug Products for Biological Medicines: Novel Delivery Devices, Challenging Formulations, and Combination Products

The importance of investing science and technology into drug product development has become evident as different product types, higher protein concentrations, and doses and requirements for improved delivery of biological drug products have increased. The need to give patients larger and more concentrated doses has challenged formulation scientists and driven development of new technologies that can deliver those doses. Delivery devices fall under device regulations and have distinctly different design, development, and validation requirements from those of protein drug products…

Expanded Change Protocols: Benefits, Cost Considerations, and Regulatory Views

The US FDA Office of Biotechnology Products’ quality by design (QbD) pilot program defines an expanded change protocol (eCP) as a particular type of comparability protocol that will “describe the quality by design, risk- based approach linking attributes and processes to product performance safety, and efficacy” (1). Sponsors have explored a wide range of potential applications for eCPs (e.g., movement within or beyond an established design space, site transfers, and additional process modifications supported by either a QbD or traditional…

A Quick Guide for Sourcing Biopharmaceutical Raw Materials

Before the ratification of regulatory guidelines from The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q8–Q11 (1–4) — whose scope includes raw materials for biopharmaceutical production — many drug manufacturers chose the most cost-effective and readily available raw materials sourcing options without specifically considering the provenance of those materials. Depending on the chosen supply chain, such materials could be of widely varying quality and not necessarily suitable for a destined application. Raw-material…

A Case for Biopharmaceutical Operations in Low-Cost Countries to Maximize Return on Investment

A company’s success is associated with its growth. An expanding company hires more employees (full-time equivalents, FTEs) to support its commercial products, to develop new products, and to provide administrative services. As it grows, an organization can become more complex and its operations less efficient. Analysis of 2013 financial data showed that revenue of US biopharmaceutical companies increases with a growing number of FTEs at a slower rate than does cost (1). That study assumed that all US biopharmaceutical companies…

Special Report: The Path to Vaccine Profitability

Managing vaccine supply chain improvements involves a complex interaction of laboratories, other facilities, CMOs, and suppliers. Since the business of making vaccines became a commercial proposition, profitability has often been elusive. The economics are difficult: Costs of development and production, already high, are rising. Profit margins historically have been lower than those of other pharmaceutical products, in part because of the complexities of manufacturing and distributing vaccines as well as their stringent safety, testing, and quality requirements.

Cancer Innovation Forum Calls for Improving US Research “Ecosystem”

Accelerating the commercialization of promising new cancer treatments relies on ensuring that patients — individually and collectively — are actively involved throughout research and drug development. This was the consensus of leading scientists, advocates, and government officials meeting in Washington, DC, at the first national policy forum convened by the Cancer Innovation Coalition (CIC). A collaboration of cancer stakeholder organizations and others working through a national campaign called Project Innovation — which is spearheaded by National Patient Advocate Foundation (NPAF)…

From the Editor and Spotlight

From the Editor Many publishers are grappling with managing and predicting the course of print and digital publishing. For academic journals with relatively few paid subscribers and/or association members focusing on specialty subject matter, going digital may make good sense — especially if that can lower subscription costs. However, BPI is a hybrid of reviewed journal and trade publication, addressing many reading and advertising preferences. The choice of which content to offer in print and which to duplicate or offer…

The CMC Strategy Forum Series, Part 1 – QbD and Risk Management

Introduction by Cheryl Scott The CMC Strategy Forum series provides a venue for biopharmaceutical product discussion. The meetings focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of the forum meetings are published in BioProcess International. This process is meant to help ensure that biopharmaceutical products manufactured with…