Business

Seamless Transition from R&D to Manufacturing

Fast and cheap: These criteria are becoming ever more urgent drivers for manufacturers of biologics, faced with increased scrutiny on the costs of developing novel drugs, the lengthy timelines for delivering these drugs to patients, and the tightening competition to capitalize on new targets. The challenge for manufacturers is further heightened by the expectations to deliver on quality as well. Although development and production of molecules such as monoclonal antibodies (MAbs) have greatly benefited from the “platformization” of core technologies…

BioProcess Insider BPI Theater @ BIO 2018 Interviews – Tuesday

BioProcess Insider brings the news as it breaks. At the BPI Theater @BIO, editor Dan Stanton conducted a series of interviews live on stage to report on the latest movements in the biomanufacturing industry to start each busy day of dealmaking in Boston. Below we summarize his DAY ONE conversations with a number of biopharmaceutical executives on Tuesday 5 June 2018. You can watch the full interviews online at www.bioprocessintl.com/BIO-Theater-2018. Andy Topping, Chief Scientific Officer, Fujifilm Diosynth Biotechnologies Gene therapies show…

Therapeutic Modalities: Business and Manufacturing Strategies Influencing Decisions to Develop One Therapy Type Rather Than Another

Moderator Patricia Seymour, with John Lee, Michael Kaufman, Jennifer Michaelson, and Weichang Zhou Following introductions of the panelists and their companies’ technologies, moderator Patricia Seymour began the discussion about challenges related to choosing different modalities and addressing related manufacturing concerns. Targeting Modalities Michaelson began by describing how Cullinan Oncology selects its targets and modalities, how it approaches those early phase decisions, and what its primary driver is to get into the clinic as quickly as possible. She talked about challenges…

BioProcess Insider Interviews at the BPI Theater @ BIO 2018 – Mass Bio and Bioasis

At the BPI Theater @ BIO, editor Dan Stanton conducted a series of interviews live on stage to report on the latest movements in the biomanufacturing industry to start each busy day of dealmaking in Boston. Below are the videos from conversations with David Lucchino, chairman, Mass Bio; and Mark Day, president and chief executive officer, Bioasis. Massachusetts: Secrets to Success Lucchino explains that when you have a set of companies in an area, it lays the groundwork for growth…

eBook: Biopharmaceutical Training – Train Your Team to Meet Evolving Industry Needs

Welcome to this year’s focus on industry training programs. In the past three years we’ve brought this information to you in several forms: as a full supplement issue (2016), a featured report (2017) – and now this ebook. Each program that we’ve profiled offers its unique approach to training present and future biotechnologists. The best of the programs offer hands-on training with current equipment provided by supplier partners and with up-to-date approaches to documentation and regulatory requirements. Many university- and…

Demand for Capacity Drives China’s Biomanufacturing Expansion

Over the past year, most of China’s biomanufacturing facilities have been engaged in active facility expansion. Based on our research of facilities under active construction, that growth has expanded total capacity in China by over 10%. Our research updates the Top 60 Biopharmaceutical Manufacturers in China directory from BioPlan Associates (1) and shows a continuing increase in new bioprocess capacity. This trend is unlikely to abate. As well as contacting our top 60 biomanufacturers, in fact, we contacted a number…

Statistical Properties of WECO Rule Combinations Through Simulations

The practice of quality control is promoted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). A number of process control charts are used in many biopharmaceutical companies to increase production and lower process costs. Here we focus on performance of three commonly used control charts: Shewhart control charts with WECO and supplementary rules, monitoring charts with exponentially weighted moving average (EWMA), and cumulative sum (CUSUM) charts. WECO rules got the name from a quality control…

Innovators and Biosimilar Companies: Experts Predict Intense Conflicts Ahead

CPhI Worldwide (organized by UBM) announced last fall the final section findings of the fifth edition of the CPhI Annual Report. Presented live at the meeting in Frankfurt, Germany, the report is now available online. It highlights immediate and long-term trends in pharmaceutical data, regulation, generics, and biosimilars. Four experts gave their views. They warned that the US Food and Drug Administration’s (FDA) approach to achieving six-sigma (nearly perfect or 99.9997% defect-free) quality is failing in respect to the pharmaceutical…

Your Brand Is the Patient’s Experience

The future success of biopharmaceutical businesses will depend at least partly on their ability to create meaningful brand experiences from the start of a drug program. By “brand,” I don’t mean logos and taglines. I’m talking about meaningfully unique experiences that directly affect clinical and patient needs — specifically, to address the growing demand for self-administered injectable therapeutics. Whether you are a biosimilar developer trying to carve out differentiated value or a market leader looking at your patent protection in…

Cost Analysis of Cell Therapy Manufacture: Autologous Cell Therapies, Part 1

Cell therapies are a growing area of interest for the treatment of a number of indications such as neurological, cardiovascular, and ophthalmological maladies that are refractory to other more conventional drug therapies. A number of cell-based therapy products currently are undergoing clinical trials. The most common target is oncology, which represents 46% of all cell-based therapies through the use of traditional blood-cell and immune-cell–based therapies. For treatment of various cancers, immune cells, lymphocytes (natural killer cells, T cells, and B…