This interview features: Raphael Gübeli, PhD, Head of Marketing, c-LEcta. Dr. Raphael Gübeli, Head of Marketing at the German enzyme manufacturer c-LEcta will discuss recent trends related to the manufacturing of cell and gene therapies and how DENARASE® and other GMP enzymes can play an important role.
This interview features: Claes Gustafsson, Co-Founder and CCO, ATUM. Launched only a few years ago, the Leap-In Transposase platform has rapidly become an industry standard technology for the generation of CHO cells for the manufacturing of antibodies and other biologics. This presentation will highlight achievements and case studies of the platform including high titer MAb manufacturing, rapid anti-COVID responses, and some novel, next generation, applications. Speaker Bio: As ATUM’s Co-Founder and CCO, Dr. Claes Gustafsson oversees most of the…
This interview features: Mark Schofield, PhD, Senior R&D Manager, Pall Biotech. Schofield was interviewed at BPI West 2023 by Informa Connect Life Sciences Producer, Anna Brown about his talk on process intensification of monoclonal antibodies. Description: Streamlined process intensification of MAb production can provide a reduction in cost and increase accessibility. Here, a multifaceted approach is taken to address the process intensification of a biosimilar. Design of Experiments (DoEs) spanning sequential unit operations focused on the interconnectivity of the process,…
With proliferating modalities entering and moving through the biopharmaceutical industry’s development pipeline, drug presentations are expanding and diversifying to accommodate. Even “traditional” biologics such as monoclonal antibodies (MAbs) have evolved in their formulation and packaging, with the emergence of highly concentrated drug products, prefilled syringes, and devices that enable patients to inject themselves at home rather than visiting a local clinic for drug infusion. Patients, clinicians, and payers are demanding convenience and cost-effectiveness as well as safety, quality, and efficacy…
The first event that we editors attend each year usually is the annual WCBP (Well-Characterized Biopharmaceutical Products) conference hosted by CASSS, formerly the California Separations Science Society. Held in Washington, DC, each January, the meeting is prefaced by a day-long offering of two CMC Strategy Forums. The combined event brings together scientists and regulators from around the world to explore current issues in biopharmaceutical development from a chemistry, manufacturing, and controls (CMC) perspective. Presentations often include updates and progress reports…
Pharmaceutical companies and regulatory agencies strive to foster scientific excellence in drug development and evaluation so that members of the public can access the high-quality medicines that they need. Recent European Medicines Agency (EMA) approvals for COVID-19 vaccines highlight those organizational accomplishments and showcase the application of risk-based chemistry, manufacturing, and controls (CMC) flexibilities that are embedded within the European Union (EU) regulatory system. Many of the CMC flexibilities outlined herein were established for PRIME (priority medicine), a scheme that…
For many life-science researchers at universities and other institutions, documenting and disseminating discoveries through publication is the natural culmination of their work. It is the process by which researchers, a group that includes principal investigators (PIs), postdoctoral researchers, and graduate students, advance their careers. It is a core piece of their continual efforts to secure funding for future work. Most researchers are rewarded for the number and quality of their publications, which are judged, in part, by their impact factor…
Human medicinal product manufacturers face complexity and uncertainties regarding operational performance. Effective training management plays a major role in support and implementation of a pharmaceutical quality system. The minimum regulatory requirement is to employ adequately trained personnel with sufficient knowledge, skills, and experience. Software-based e-learning training methods are used widely across pharmaceutical companies. Achieving quality compliance depends significantly on several factors, from training preparation to assessments. To comply with the current regulatory requirements, pharmaceutical companies need to implement learning management…
Failure to detect breaches in chromatography column performance can be disastrous during large-scale commercial manufacturing. Our company uses algorithm modeling for near–real-time monitoring of column packing quality and sensitive detection of column-integrity breaches. The approach enables us to mitigate risks early on, save cost and time, and thereby deliver consistent product quality and purity during manufacturing. Here we discuss three case studies in which predictive algorithm modeling using moment analysis and direct transition analysis (DTA) helped us monitor column integrity…
According to the World Health Organization (WHO), more than 350 million people worldwide are chronic carriers of hepatitis B virus (HBV) (1). Around 25% of carriers develop liver cirrhosis and/or carcinoma, making HBV responsible for the deaths of one million people annually (1). The virus has a spherical shape with a lipoprotein coating mostly of HBV surface antigen (HBsAg) (2). Knowing that, drug developers have created recombinant HBV vaccines based on HBsAg synthesized in yeast or mammalian cells (3, 4).…