Business

eBook: Working Together Is Key to Bioprocess Sustainability

by , and

Sustainability initiatives are launching across the biopharmaceutical industry as companies begin to scrutinize their environmental impacts as part of the growing environmental, social, and governance (ESG) movement in business. Achieving ambitious sustainability goals will require organizations to evaluate their raw materials, production processes, product packaging, operations, and supply and distribution chains — and such work will entail monumental effort. As this special eBook presentation from the editors of BioProcess International and BioProcess Insider demonstrates, bioprocess sustainability necessitates collaboration across the…

Addressing Gaps in US Biomanufacturing Capacity

by

In December 2022, the President’s Council of Advisors on Science and Technology (PCAST) submitted a report to Joe Biden about biomanufacturing in the United States. In a letter prefacing the report, the council cochairs noted that the bioeconomy is “poised for enormous growth over the coming decades” (1). On 22 March 2023, the White House Office of Science and Technology Policy responded with a set of five initiatives to help realize the potential of the nation’s bioeconomy. The broad goal…

The Future of Virtual Audits and Audit Success

by

Audits are a vital quality-management tool in the biopharmaceutical industry. Whether the activity is verifying supplier or partner qualifications, contributing to corrective and preventative actions (CAPAs), or fulfilling regulatory requirements, proactive auditing is key to successful operations. Over the past couple of years, virtual audits — also known as remote or distance audits — have enabled biopharmaceutical companies to maintain compliance and quality-assurance (QA) demands despite COVID-19–related travel restrictions and social-distancing protocols. Now that the world is opening up again,…

Pharmaceutical Manufacturing Quality Assurance Programs: Transitioning from Research and Development to the Clinic

by , , and

On average it can take or even exceed US$1 billion to get a pharmaceutical product to market, and nine out of 10 products developed never make it to commercialization (1). As technology advances, more potential therapies and preventatives are being developed and optimized by virtual companies. They are typically small, newly formed organizations that build their momentum on programs for novel products. Because many of the program activities are outsourced, virtual start-up companies developing pharmaceutical products raise concerns about ensuring…

Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance

by , , and

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidance on the testing and evaluation of viral safety of biotechnological products derived from characterized cell lines of human or animal origin through its harmonized guideline ICH Q5A (1). The latest revision, released for consultation in October 2022, maintains the key principles of previous versions while introducing key changes in response to important advances in the field. Those advances are covered in new sections that…

May 17, 2023

Streamlining and Accelerating Biosimilar Adoption in the United States

by

Biologic medicines have brought extraordinary clinical benefits to patients living with difficult conditions such as cancer and autoimmune and ophthalmic diseases. But such therapies are expensive, accounting for about 43% of pharmaceutical spending in the United States (1). The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created a regulatory pathway for a class of biologics called biosimilars, which replicate branded biologic drugs at lower cost (2, 3). The BPCIA was designed to provide greater access to biologics by…

May 17, 2023

Cell Lines Are the Foundation: A Methodical Approach to Derisking Outsourced Development and Improving Manufacturability of Novel Biologics

by

The most important choice for bringing a novel biologic into clinical development could be the cell line for expressing it. Somewhat determined by that, development of the initial manufacturing process comes in a close second. After an investigational new drug (IND) application, early clinical studies use materials made from the cell line and manufacturing process that were selected at the start of a clinical candidate’s life cycle. The objective for most sponsor companies is to get IND-enabling material produced in…

April 20, 2023

Biopharma 4.0 — the Talent Evolution

by , , , , , and

Biopharma 4.0 refers to applications of data and digital technologies to biotherapeutic manufacturing. Technological advances now enable the internet and its embedded systems to serve as a nucleus through which biomanufacturers can integrate production lines and processes across organizational boundaries, thereby forming a networked and agile value chain. Solutions under the industry 4.0 umbrella include • platforms for “smart” manufacturing made possible by the internet of things (IoT) • artificial intelligence (AI) • systems for process automation • technologies for…

April 20, 2023

Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System

by

Pharmaceutical companies and regulatory agencies strive to foster scientific excellence in drug development and evaluation so that members of the public can access the high-quality medicines that they need. Recent European Medicines Agency (EMA) approvals for COVID-19 vaccines highlight those organizational accomplishments and showcase the application of risk-based chemistry, manufacturing, and controls (CMC) flexibilities that are embedded within the European Union (EU) regulatory system. Many of the CMC flexibilities outlined herein were established for PRIME (priority medicine), a scheme that…

March 21, 2023

Patent Before Publish: Maximizing the Benefits of Your Research

by

For many life-science researchers at universities and other institutions, documenting and disseminating discoveries through publication is the natural culmination of their work. It is the process by which researchers, a group that includes principal investigators (PIs), postdoctoral researchers, and graduate students, advance their careers. It is a core piece of their continual efforts to secure funding for future work. Most researchers are rewarded for the number and quality of their publications, which are judged, in part, by their impact factor…

March 21, 2023