Stem cells have potential as a readily available, consistent source of many differentiated cell types. This unique property can be leveraged both for therapeutic purposes and for facilitating and improving a number of drug discovery and development processes. Large-scale, “industrialized” production of human stem cells in tightly controlled conditions will be required to deliver the quantity and quality of cells needed to support clinical trials and drug discovery development activities (Figure 1). Achieving this level of production while meeting rigorous…
Friday, October 1, 2010 Daily Archives
Increasing Biopharmaceutical Quality Through Packaging Partnerships
Containers and administration devices are integral to the safety and efficacy of biopharmaceutical therapies and must be key considerations for all new drugs coming on the market. By partnering with packaging manufacturers early in development, biopharmaceutical manufacturers can increase efficiencies in their production processes while gaining expert advice and counsel throughout a drug’s lifecycle. Such an alignment can also improve product quality, enhance regulatory compliance, and contribute to the overall state of control by preserving biopharmaceutical stability, ensuring sterilization, and…
How to Choose an Industrial Cation Exchanger for IgG Purification
Cation-exchange chromatography is the third most used industrial method for antibody purification after anion-exchange and protein A affinity chromatography. It is most commonly used as an intermediate step but continues to attract attention as a capture method. This offers obvious cost and cleaning advantages over protein A but also imposes some sacrifices, all of which are discussed in a number of recent articles (1,2,3,4,5). Whichever application may be intended, end users seek a common set of performance characteristics.…
Minimizing the Environmental Footprint of Bioprocesses
Part 1 of this two-part article introduced the need to reduce the environmental footprint of bioprocesses and evaluated the impact of solid-waste disposal. Part 2 continues by describing the effects of the remaining elements of the bioprocess footprint: wastewater, electricity, and air emissions. Wastewater Process Waste Streams: Generally, raw materials to produce and purify biopharmaceuticals fall into one of the following categories: inorganic/organic salts, sugars/polyols, trace elements, vitamins, amino acids, surface active agents, or complex (undefined)…
Formulation Effects on Opalescence of a High-Concentration MAb
Monoclonal antibodies (MAbs) are increasingly formulated at concentrations >100 mg/mL as a means to deliver a high dose in a low volume (1,2). Such high-concentration solutions are commonly opalescent (3,4), an undesirable characteristic of biopharmaceutical products for several reasons. Although it may be only aesthetic, opalescent products are not considered pharmaceutically “elegant.†Of more serious concern, opalescence may be a precursor to aggregation and indicate a propensity toward decreased product stability or quality. The term opalescent refers to…
Rapid and Scalable Microplate Development of a Two-Step Purification Process
High-throughput screening and process development methods are becoming more widely used in the biopharmaceutical industry. Recent development of high-expression (high–target-titer) recombinant culture methods has enhanced the need to also develop more effective separation products, methods, and processes (1). Part of the solution would be chromatographic resins offering higher capacities and flow rates. However, developing an optimized purification process that involves several chromatographic steps can consume significant time and samples. In addition, a purification process developed…
Global Marketplace
Automated Osmometry Product: Advanced 20G high-throughput osmometer Applications: Cell culture process development and optimization Features: The Advanced 20G high-throughput osmometer combines state-of-the art osmometry technology and robotics within a parallel sample processing scheme. Samples can be analyzed in a 96-well format within 35 minutes with the same accuracy as stand-alone osmometers. The 20G system supports osmolality testing in even the most demanding cell culture process development schemes in the biopharmaceutical industry. Contact Advanced Instruments Inc. www.aicompanies.com UV Calibration Product: Calibration…
IBC’s Sixth Annual BMD Summit Biopharmaceutical Manufacturing and Development Streamline Facility and Capacity Management, Minimize Downtime, and Mitigate Raw Material Risk
The BMD Summit comprises two in-depth tracks, a combination of programming that will help you increase your manufacturing agility, reduce process variability, and achieve your manufacturing and development goals. Tracks and Session Topics Preconference Workshop: “Mitigating the Risk and Impact of Viral Contaminations: Technical Aspects” (new this year) Track #1, Enabling Efficient Facilities: This track provides you with insights on how to achieve scale and product flexibility. You will hear perspectives from major biopharmaceutical companies on when and where to…
30th Anniversary of Smallpox Eradication
May 2010 marked the 30th anniversary of the World Health Organization’s declaration that the world had won freedom from smallpox. An intensive two-year search had discovered no evidence of the disease since the last case on 26 October 1977. It was a historic moment — no disease had ever before been eradicated. Smallpox had terrorized humans for more than 3,500 years and in the 20th century alone had been responsible for 300 million deaths. The success of the…
Preclinical Immunogenicity Assessment
Protein therapeutics can potentially elicit immune responses when administered in humans. These antidrug antibodies could result in partial or complete loss of drug efficacy and other complications that have the potential to cause severe adverse effects in the patient. In this webcast, Philippe Stas, Head of Applied Protein Services at Lonza, discusses the benefits of preclinical immunogenicity assessment, including:
• Early-stage Risk Assessment
• Improved Quality and Safety of Drugs
• Reduced Attrition Rate in Drug Development Programs
View this webcast to learn more about managing drug-induced immune responses at the earliest possible stage to produce safer and more cost-effective protein therapeutics.