Regulatory Affairs

Management, Notification, and Documentation of Single-Use Systems Change Orders: Challenges and Opportunities

by and

Single-use systems (SUS) consist of numerous plastic components derived from different suppliers. As such, they are prone to changes, including alterations in construction materials or modifications in manufacturing processes. Such changes may originate at the immediate supplier or farther back in the supply chain as a result of product improvements, process improvements, part discontinuation, or even business decisions such as manufacturing site relocation. Whether those changes are major or minor, managing their impact on biopharmaceutial processes and product quality often…

October 15, 2015

Planning for Commercial Scale of Cell Therapy and Regenerative Medicine Products, Part 2: Clinical Efficacy, Reimbursement, and Needle-to-Needle Logistics

by , and

Cell therapy is an emerging pillar in healthcare with the potential to provide curative solutions to a wide range of indications. The biological complexities through which cell technologies exert their clinical impact (especially those used in immunotherapies for cancer) provide opportunities for novel modes of immune regulation, cell targeting, and payload delivery. Cells also can serve as vehicles for genetic content, which the gene therapy industry is now investigating. Since early 2004, Invetech has worked with organizations dedicated to cell…

October 15, 2015

Comprehensive Hands-On Training for Biopharmaceutical Manufacturing: BTEC’s Program to Deliver Training to FDA Investigators

by and

Training and continuing education play a vital role in carrying out the US Food and Drug Administration’s mission to protect and promote the public health — not only for consumers, health professionals, and industry, but also for the agency’s own personnel. Since 2008, the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University has filled a niche in the agency’s internal training program and provided a series of courses to more than 100 FDA investigators. The…

September 23, 2015

Challenges in Implementing Quality By Design: An Industry Perspective

by

In the fall of 2004, the US Food and Drug Administration (FDA) published a final report entitled Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach (1). This publication set the groundwork for a prospective risk‑based approach to pharmaceutical product development. It was published on the heels of a November 2003 agreement between the FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to develop an internationally harmonized plan for developing…

June 16, 2015

Can English Unite SE Asian Markets?

by

By 2016, the global pharmaceutical industry is expected to generate an estimated 30% of its total sales in emerging markets (1). After India and China, southeast countries such as Indonesia, Singapore, Malaysia, Vietnam, and Thailand are especially attractive markets. The Association of Southeast Asian Nations (ASEAN) Economic Community (AEC) consists of 10 countries united through regional economic cooperation: Thailand, Myanmar, Laos, Vietnam, Malaysia, Singapore, Indonesia, Philippines, Cambodia, and Brunei. The ASEAN Community 2015 (AEC 2015) initiative aims to form a…

May 12, 2015

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

by , , , , , , and

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…

March 10, 2015

Cancer Innovation Forum Calls for Improving US Research “Ecosystemâ€

by

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)…

February 6, 2015

Fundamental Strategies for Viral Clearance – Part 1: Exploring the Regulatory Implications

by

Over the past several decades, biologics such as monoclonal antibodies (MAbs) and recombinant proteins have provided therapeutic benefits and efficacy for the treatment of human disease. Completion of the human genome project (launched in 1990) produced a draft of the genome in 2001. A full sequence was published on the 50th anniversary (2003) of the initial publication of Watson and Crick’s papers on the double-helical structure of DNA (1). That large volume of genetic information has been translated into usable…

January 13, 2015

The Single-Use Watering Hole: Where Innovation Needs Harmonization, Collaboration, and Standardization

by and

Within the past few years, the single-use technology (SUT) arena of the biopharmaceutical industry has exploded in growth. Leading organizations have predictably and understandably stampeded to the “watering hole†of single-use to drink up the advantages that disposable components offer over traditional multiuse parts and technologies. The initial value and risk-reduction results are being realized — but not without the emergence of other trade-offs. End users continue to call for standardization in emerging areas of the industry while also recognizing…

January 13, 2015

Accelerated Product Development: Leveraging Industry and Regulator Knowledge to Bring Products to Patients Quickly

by , , , , , , , , , and

A Chemistry, Manufacturing and Controls (CMC) Strategy Forum titled “Accelerated Product Development: Leveraging Combined Industry and Regulator Knowledge to Bring Products to Patients More Quickly†was held in Washington, DC, on 27 January 2014. Biological therapeutics in development are demonstrating remarkable results in the clinic for many indications. So companies are seeking ways to accelerate the approval of these therapies and rapidly bring them to market. Many such products take the form of well-characterized proteins (e.g., IgG1 or IgG2 monoclonal…

December 11, 2014