Business

Activatable Immunoconjugates for Target Cancer-Cell–Specific Diagnosis and Therapy

In cancer treatment, early diagnosis and targeted therapies are assumed to yield the highest cure rates. However, most current methods are limited by their low sensitivity to early disease and a lack of specificity for targeted cell killing. Newly developed, activatable immunoconjugates assist in the accurate detection of cancer through in vivo imaging with high target-to-background contrast (1,2). They also provide for the possibility of highly specific, light-mediated treatment with minimal effects on healthy cells surrounding tumors (3). In fact,…

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,…

Accelerating Purification Process Development of an Early Phase MAb with High-Throughput Automation

    Monoclonal antibodies (MAbs) are the fastest growing segment in the biopharmaceutical industry because they are potentially efficacious in the treatment of diseases such as cancer and autoimmune disorders (1,2). With steadily increasing demand for efficient and affordable therapies, speed to clinic/market is important, and biopharmaceutical companies push multiple drugs into development each year to ensure business sustainability (3,4,5,6). Downstream purification process development for therapeutic MAbs is a critical step on their path to reach clinical trials and beyond…

Single-Use, Continuous Processing of Primary Stem Cells

Many potentially therapeutic products involve the culture of stem cells. Their commercial success depends on the development of scalable good manufacturing practice (GMP) technologies that can both robustly and cost-effectively produce very large numbers of cells. Through many improvements and innovations in bioprocessing operations over the years, fed-batch suspension culture has remained the most common mode for large-scale biopharmaceutical manufacturing. However, some recent events suggest that may be changing (1,2). For the culture and expansion of stem cells, large-format adherent…

Bioprocess Advances Drive Vaccine Manufacturing in Developing Countries

Advances in bioprocessing technology hardware and genetic engineering are expanding the geographic options for biologics manufacturing to include developing and emerging economies. Such advances are beginning to permit biopharmaceutical production in regions that previously lacked the technical expertise or quality processes to permit complex operations, monitoring, record-keeping, and oversight. Global demand by countries for in-country production of biological vaccines is increasing, so those products tend to be leading the way in terms of adoption of modern bioprocessing in developing countries.…

Evolving Biologics Demand Spurs New Facility Needs

In the era of biologics manufacturing, chemical medicine production facilities are becoming the dinosaurs of the life sciences sector. Traditional chemical facility development and management systems are simply unequipped to support the highly sensitive — and highly regulated — process of developing and producing biological and biosimilar medicines. Renovating or building such facilities anew is a mammoth undertaking by any measure. All signs point to the value of evolving facility design and management to house more sophisticated biologic laboratory services.…

Innovation in Biopharmaceutical Manufacture

The following is a report from a workshop on innovation in biopharmaceutical manufacturing held at the Annual bioProcessUK Conference in Bristol on 29 November 2012. The aim of the workshop was to access the experience of practitioners in the United Kingdom so as to understand better the challenges and opportunities for innovation in this sector. The workshop addressed the drivers that influence the implementation of process improvements and novel technologies in biopharmaceutical manufacture from the perspective of both manufacturers and…

Optimizing for the Future

The 2013 biennial meeting of the European Society for Animal Cell Technology (ESACT) was in Lille, France this past June. While there, BPI editorial advisor Miriam Monge (vice president of Biopharm Services Ltd.) interviewed ESACT executive committee member Hitto Kaufmann, PhD (vice president of biopharmaceutical process sciences for Boehringer Ingelheim). They talked about some scientific developments being discussed at this year’s ESACT conference as well as Boehringer Ingelheim’s recent announcement about setting up in China and Kaufmann’s own thoughts on…

Outsourcing Facility Safety for Biomanufacturing

As the life-science industry increasingly outsources noncore functions, some companies are finding that managing the expanding web of safety and environmental requirements associated with various functions is, in turn, growing vastly more complex. As multiple third parties handle numerous noncore activities, the risk — and headaches — of monitoring them effectively is a growing challenge by any standard. At first glance, the lowest-risk solution for many organizations may seem to be managing associated safety programs with in-house personnel and programs.…

A Sustainable, Single-Use Facility for Monoclonal Antibody Production

Pierre Fabre, the second largest independent pharmaceutical group in France, recently opened a new facility to expand its monoclonal antibody (MAb) production for clinical supply. The Antibody Biotechnology Unit (ABU) facility was designed to provide needed flexibility for adapting to various process and capacity changes, so it includes state-of-the-art single-use technologies. The facility was also built with sustainability in mind to minimize the company’s environmental footprint. The company integrated this plant into an existing antibody research and development (R&D) center,…