Search results for " development" in Articles / App Notes
Article
Establishment of New Modern Plasma Fractionation Facilities in Asia
Neil Goss, an international consultant in biotechnology and plasma fractionation, past director of Research and Development at CSL BioPlasma, Australia, and co-author of Production of Plasma Proteins …
Article
Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
Korea, Japan, and Singapore, in particular, have a well-established biopharma industry with development and manufacturing capabilities that compete with businesses in North America or Europe at eye le…
Article
Reconciling Sensor Communication Gaps
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors and probes. Single-use systems …
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Poor stability of monoclonal antibodies outside their natural environment, however, is one of the major challenges in product development (2–6). A number of non-optimal formulation, manufacturing, or …
Article
Managing Risk in Raw Material Sourcing
IPEC has developed standardized templates and materials to help simplify supplier evaluation and auditing, as well as the development of quality agreements, and to ensure consistency. Having additiona…
Article
Fluid Handling in Biopharma Facilities
BioPharm International spoke with Max Blomberg, director of operations at Meissner; Luis Tissone, director of life sciences at Trelleborg Sealing Solutions; Todd Kaap, sales and market development man…
Article
Aseptic Processing: Keeping it Safe
…hort heat stress in BFS may be acceptable, as long as it has been evaluated and addressed during the development process—but the long-term compatibility concerns remain. Systems can be added to a sta…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Risk Assessment Tools
BioPharm: What current tools are used in risk assessment and mitigation in biopharma manufacturing? Are there tools in development?
AstraZeneca: We often use a modified v…
Article
USP Publishes Monoclonal Antibody Guidelines
…at would be more amenable to a “platform approach” both in terms of manufacturing and analytical development.
USP has been involved in developing quality standards for biologics as part of its ex…
Article
Labeling of Biosimilars
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has reached a key stage in the lengthy process of creating a regulatory framework for the development and…