Author Archives: BPI Contributor

eBook: Advances in Single-Use Platforms for Commercial Manufacturing

This special report from Sartorius Stedim Biotech explores recent advances in single-use process platforms for commercial production of biopharmaceuticals. Enormous developments have been made in single-use systems, allowing biomanufacturers to adopt the technology in critical applications within their commercial-scale facilities. The authors illustrate how companies can work with teams of experts from supplier organizations to implement end-to-end single-use bioprocesses at scales up to 2,000 L by carefully considering the approach from the earliest stages in process development. Finally, the report…

eBook Download: A New Paradigm in Process Development

  As the need to accelerate biopharmaceutical development around the world continues to grow, biomanufacturers face a host of challenges so they, too, can grow. Increasing process productivity, reducing cost, mitigating risk, and bringing products to market faster are just a few of the issues frequently addressed. But with support in process development, cGMP manufacturing and training, accelerating bioprocess development can become less challenging. Several biomanufacturers have successfully navigated these issues in collaboration with GE Healthcare’s Fast Trak Services. Whether…

Planova BioEX: Leading the Next Generation of Virus Filters

This webcast features: Daniel Strauss, PhD, Principal Scientist, Research and Development group at Asahi Kasei Bioprocess America Virus filtration is a critical unit operation in the manufacture of biotherapeutic products owing to its capability to remove a broad range of viruses. Selection of virus removal filters based on filterability and virus removal performance over a range of process conditions ensures predictable processes. The Planova™ BioEX filter shows high flux with minimal flux decay for some of the most challenging products…

Digitization of Biology to Revolutionize Lab Productivity

Biological research is limited by a technical barrier that exists between scientists and lab hardware. Each piece of hardware has its own software, its own file format and its own eccentricities, which the user needs intimate familiarity with to get the most from the machine. Using Antha, a user-friendly but hugely powerful software platform, gives biologists sophisticated, flexible and integrated control over lab hardware. This enables experiments and lab workflows to be rapidly automated, with data automatically integrated and linked…

Dynamk Capital Invests in Envisagenics to Advance AI Drug Discovery

Dynamk Capital, a recently launched life sciences venture capital fund, today announced an exciting new investment in early drug discovery by adding Envisagenics, Inc. to its growing portfolio. Dynamk’s portfolio companies provide technologies and services that enable biopharmaceutical companies around the world to develop therapeutics faster and produce them more economically. Dynamk Capital invested $500,000 in Envisagenics, leading the $2.25 million seed round alongside other investors. Envisagenics, a life science company applies artificial intelligence to the genetic sequence of patients…

Flavivirus Vaccine Production Accelerates with Modern Bioprocess Tools and Solutions

As with all viral vaccines, the complex nature of flaviviruses makes process development technically challenging. In addition, vaccine production can be both costly and difficult to scale to meet market demands. In egg-based vaccine production, for example, 100–300 vaccine doses can be produced from one fertilized hen’s egg. However, the eggs used for production need to be supplied from special pathogen-free chicken flocks, limiting availability of eggs and making vaccine production difficult to scale up. To meet the needs of…

Pfizer Collaborates to Accelerate Approval of Biosimilar MAbs in China

In their pursuit of developing therapeutics, biopharmaceutical companies face many challenges, including pressure to meet aggressive timelines, reduce risk and cost, and increase speed to market. Addressing these challenges is especially critical for biosimilar manufacturers, who face fierce competition and an expanding footprint in emerging markets (1). The global biosimilars market is growing rapidly and is expected to exceed more than US$6 billion by 2020 (2). This case study describes how Pfizer is collaborating with GE Healthcare to achieve regulatory…

Roivant Sciences Accelerates Process Development to Speed Orphan Therapy to Market

Although the demographic of orphan therapies is small, making therapies for rare diseases available has a huge impact for the affected patients. Cooperation to expand capacity and expertise during process development and manufacturing for preclinical and clinical phase studies is one way to increase speed to market. This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies. Frequent communication between the Fast Trak…

MAbxience Optimizes and Accelerates Downstream Biosimilar Process Development

Biosimilars represent an innovative solution that can benefit both patients and healthcare systems by reducing the burden of rising treatment costs. To improve the availability, price, and access of medicines, many countries are implementing strategies to establish their own production capacity. To support such development, MAbxience (a Spanish biotechnology company specialized in research, development, and manufacture of biosimilar drugs) is committed to provide the manufacturing of high-quality products and processes that meet regulatory and technical requirements in all countries where…

Single-Use Automation: Unlocking the True Potential of Single-Use Technology

When single-use technology first arrived on the scene in the late nineties, the processes that it was applied to were relatively simple and low risk. These included simple filtration and storage applications of buffers and cleaning solutions. With these filtration steps typically involving lower value, non-blocking solutions of easy to dissolve salts, automation would have been seen as an unnecessary over- complication. It was thought sufficient to have an operator watch the process to make sure nothing became disconnected, a…