Search results for " meeting" in Articles / App Notes
Article
Innovation vs. Capacity: How CMOs Compete
…hose segments, and capture market share are more crucial than ever for achieving healthy returns and meeting investor expectations.
Capacity-driven CMO outlook
The challenges are particular…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization.
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Hoare, “(302c) Injectable, Degradable Thermoresponsive ploy(N-isopropylacrylamide) Hydrogels,” presentation at the 12th Annual Meeting of the AIChE (2012).
7. X.-Q. Dou et al., Soft Matter 8, pp. …
Article
Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
By Cynthia A. Challener
Biopharmaceutical manufacturing involves a series o…
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
According to the agency, to participate in the new FDA program, applicants must submit a written request for a Type C meeting to CDER-ETT@fda.hhs.gov. Requests can include an explanation of the new te…
Article
GMP Challenges for Advanced Therapy Medicinal Products
The meeting also acknowledged that the term “GMP grade” meant different things to different groups, according to an EDQM report on the conference (5).
Adapting GMP implementation based on risk
S…
Article
Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…