Intellectual Property

Decision-Support Tools for Monoclonal Antibody and Cell Therapy Bioprocessing: Current Landscape and Development Opportunities

Industrial-scale manufacturers in a number of fields — from automobiles to biotherapeutics — have long relied on powerful computational and mathematical tools to aid in the scale-up, optimization, quality control, and monitoring of product development (1–5). Typical process pathways are highly multifactorial, with numerous branch points, feedback steps, instrumental attributes, and target parameters. Moreover, margins for error are minimal for most industrial processes, requiring high standards of precision from industrial and operational pathways (6). For those reasons, the complexity of…

Secondary Packaging: Creating Value with Product Lifecycle Management

with Daniela Guttmann and Susanne Hall Increasing regulatory requirements combined with the market pressure to develop patient-friendly drug delivery systems make product lifecycle management (PLM) a decisive field for today’s pharmaceutical and biotechnology companies. Their strategic service providers also are affected by those conditions. For example, as an internationally operating contract development and manufacturing organization (CDMO), Vetter reports an increasing number of life-cycle management projects with its customers in the past years. Learn more in this white paper from Vetter.…

The 2014 BPI Awards: Recognizing Excellence in Bioprocessing

The mission of the BioProcess International publication has always been to deliver valuable industry information to the biotechnology community to continue on the path of scientific advancements, revolutionary technological applications, and strategic partnerships and collaborations. We are honored to cover this market and work with the many talented people sharing their expertise and projects. Now is the time for us to recognize and honor the outstanding people, organizations, and technologies that have significantly influenced and advanced the efficiency of biotherapeutic…

Cell Therapy Manufacturing

Fueled by a recent resurgence in public financing and compelling clinical data for indications as diverse as acute macular degeneration and pancreatic cancer, a growing number of cell therapies are driving toward pivotal clinical studies and commercialization. Although regulatory precedents have been set for various autologous and allogeneic products in the United States, Asia, and the European Union, regulatory guidance continues to evolve for a widening array of cell products. Adult stem cells (e.g., mesenchymal stem cells), embryonic stem cells,…

Deal-Making in the Biosimilars Market

Driven by significant opportunity and a perceived lower risk strategy for taking a slice of the booming biologics market, companies have been investing heavily in biosimilars to capitalize on a market that’s forecast to be worth US$3.5 billion by 2015. To exploit this opportunity, companies have embarked on a hearty meal of deal-making. Since the biosimilar market’s formal inception in Europe in 2005, deal flow has been solid. Generics companies made early forays, seeking to leverage relationships with payers and…

Intellectual Property Protection in the Digital Age

    For most biotechnology and biopharmaceutical organizations, “business as usual” means a perpetual race to the finish line: Conceive a new invention, reduce it to practice, attain patent protection, repeat ad infinitum. But sometimes, the very technologies scientists use to expedite that chain of events (e.g., electronic laboratory notebooks and cloud-based laboratory data sharing) create security and authenticity holes. In essence, the more agile and sophisticated our work flow systems become, the more difficult it becomes to guarantee the…

Technology Transfer Challenges for In-Licensed Biopharmaceuticals

    During the lifecycle of a biopharmaceutical, occasions arise in which the facility and support organization responsible for ensuring that it is manufactured according to schedule, demand, and quality specifications must change, either in whole or in part. The reasons for this vary: some related to scale, some related to clinical development phase, some related to internal manufacturing capacity and program ownership. The industry has adopted the term technology transfer to describe these events. Many such situations have been…

The Business of Biotechnology

    All companies — large and small, biotech included — have felt the pinch of the current (or recent, depending on your point of view) recession. From huge multinational companies to virtual start-ups, all are taking a good hard look at the way they do business. And as it does every year, the 2010 BIO International Convention will offer something for every company and every situation. Business-oriented sessions range from hard-earned experience to provocative new ideas. On the BioProcess…

Patents, Politics, and Polypeptides

Humor columnist Dave Barry once opined, “Without question, the greatest invention in the history of mankind is beer. Oh, I grant you that the wheel was also a fine invention, but the wheel does not go nearly as well with pizza.” Certainly, few biological concoctions have achieved that level of popularity — but with a little luck, your company will produce at least one invention with the potential for measurable success in its target market. But with success comes competition,…

The Business of Biotech

      Calivin Coolidge, who served as president of the United States from 1923 to 1929, is often misquoted as saying “The business of America is business.” According to historians, however, what he really said was, “The chief business of the American people is business.” And he went on in the same speech to say, “Of course, the accumulation of wealth cannot be justified as the chief end of existence.” So the real Coolidge (as opposed to the caricature…