Search results for " production" in Articles / App Notes
Article
Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
Article
N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
By Aled Jones
Protein glycosylation, the addi…
Article
The Tide Stays High
Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.
By Jim Miller
A year ago, the outlook for contract services was a little uncertain. Equity markets’ appeti…
Article
Technology solutions simplifying chromatography unit operations
Chromatography operations typically involve steps such as resin slurry preparation, column packing, cleaning, unpacking, and resin storage. While each of the aforementioned steps can potentially be …
Article
Reporting Quality Metrics to FDA
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
By Siegfried Schmitt
Q: We are a contract manufacturing organization (CMO), sp…
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
By Caroline Hroncich
On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discuss…
Article
E. coli growth and Dab expression in single-use and stainless steel fermentors
coli domain antibody (Dab) production process developed for a stainless steel fermentor. Cell growth,
cell density, and Dab expression levels were assessed and compared between the two production…
Article
High-Throughput Process Development in an Historical Environment
As an example of their utilization, Chris Daniels from Merck presented work with design and commissioning of a BSL-2 HTS platform for process development of viral vaccine production, where all liquid …
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
Changes are needed to maintain US biopharma innovation leadership.
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both…
Article
A Platform Approach for the Purification of Domain Antibodies (Dabs)
This Application note describes a three-step purification process of a domain antibody (Dab) expressed in the periplasm of E. coli. First, a capture step using Capto™ L was used to reduce E. coli host…