Business

Manufacture and Regulation of Cell, Gene, and Tissue Therapies: Part 2 — Regulatory Guidances

The US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and Japan’s Pharmaceutical and Medical Devices Agency (PMDA) all offer support and guidance for developers of advanced therapy medicinal products (ATMPs). Some agencies have issued guidelines to help companies through different stages of product development — from research and development to marketing authorization and postauthorization activities. Such guidelines are updated regularly as more knowledge becomes available from the development and…

Successful biosimilar development requires an outsourcing partner with the right experience

Demand for biosimilars is expected to increase significantly in the coming years, particularly in the United States. Developing new biosimilar candidates is a challenging endeavor that requires partnerships with outsourcing partners that have deep protein science, analytics, and process engineering expertise. Avid Bioservices has successfully supported biosimilar development for nearly a decade and is further expanding its capacity to provide manufacturing services from the bench through larger-scale commercialization. Anticipating Strong Growth in Demand for Biosimilars The value of the global…

Trade-Secret Vulnerabilities: Recent Hacking Schemes Highlight the Need to Protect Proprietary Pharmaceutical Information

On 21 July 2020, the US Attorney’s Office in Spokane, WA, unveiled a sweeping indictment accusing a pair of Chinese hackers of conspiring to steal trade secrets from a number of American pharmaceutical companies and research institutions, including biotechnology companies working on potential COVID-19 vaccines (1). Although the hackers apparently did not succeed in their attempt to obtain vaccine data, their years-long conspiracy involved other attacks on the pharmaceutical industry — and netted them troves of sensitive commercial information. Among…

Biomanufacturing Workforce Development: Fostering Talent During and After the Pandemic

Beyond the human suffering and economic damage caused by COVID-19, one of the most powerful results of the pandemic has been to focus global attention on drug and vaccine development for infectious diseases. Massive investments by governments, institutions, and biopharmaceutical companies have accelerated development of novel therapeutics, including messenger RNA (mRNA) and viral-vector vaccines, that are poised to become transformational platform technologies for biopharmaceutical manufacturing (1). Furthermore, the well-established technology of monoclonal antibodies (MAbs) has lived up to its promise…

Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management

This two-day CASSS CMC Strategy Forum explored many technical, practical, and regulatory facets of biological drug-product (DP) analytics, process validation, and comparability. Part 1 of this report summarized the discussions on drug-product analytics and comparability in BPI’s March 2021 issue (1). Here we report on day two presentations and discussions on validation, legacy products, and lifecycle management. Session Three: Drug-Product Validation The morning session focused on principles of process validation with examples of challenges specific to drug products. New Risk-Based…

Defining a Successful Biotechnology Entrepreneur

Having brought its first vaccine candidates from concept to clinical development in less than three months, BioNTech is making global waves as the pioneer behind Pfizer’s COVID-19 vaccine. Because of such success stories, more eyes than ever are looking at opportunities raised by the biotechnology industry. As talented people around the world from academia, clinical practice, and other industries consider careers in this sector, they should examine the characteristics necessary to become successful biotechnology entrepreneurs. Biotechnology fuses science and business.…

The EU MDR Deadline Delay: What Does It Entail for Pharmaceutical Companies?

The life-sciences industry has been working hard to meet the deadline for compliance with the European Union’s Medical Device Regulation (EU MDR, 2017/745) (1). Doing so has been a challenging journey for many companies. Therefore, the full-year postponement of the final application date has been a welcome development, particularly in view of the new and extraordinary challenges stemming from the COVID-19 global health crisis. The extension has instigated other important changes, so it is critical that life-science businesses familiarize themselves…

eBook: Vaccines — COVID-19 Invigorates a Stagnant Industry

The SARS-CoV-2 novel coronavirus has galvanized what was a stagnant and oligopoly-run vaccine industry. In this inaugural BioProcess Insider eBook, the first of four to be published in 2021, founding editor Dan Stanton explores economic and technical conditions that until now have hampered innovation in vaccine development and discouraged market entry for emerging biotechnology companies. Leveraging commentary from vaccine industry experts and analyzing the range of emerging vaccine modalities, Stanton surveys how industry responses to the COVID-19 pandemic are fostering…

The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements

The biopharmaceutical industry continues to develop advanced manufacturing processes, systems, technologies, and facilities. Regulations play a significant role in assessing and approving marketing authorizations for drug products that are submitted for approval. The industry and regulators together should form a coordinated, streamlined process that delivers much-needed medicines around the world. Global Complications The complex global nature of biopharmaceuticals sometimes means that progress is not always as smooth as it could be. One main reason is that regulatory agencies often differ…

Top Trends in Biomanufacturing

Facing an ongoing pandemic, growing pipelines, and a possible capacity crunch, the bioprocess industry is striving to balance its priorities. Those are some of the key issues to watch according to the 17th annual report and survey of biopharmaceutical manufacturing capacity and production from BioPlan Associates. It includes survey responses from 130 decision-makers (from 33 countries) at both bioprocessing organizations and contract manufacturing organizations (CMOs) and responses from 150 bioprocess industry suppliers (1). Top trends from this report are highlighted…