Analytical Advances: Calibration Management of Outsourced Calibrations

Publication
Article
BioPharm InternationalBioPharm International-02-01-2002
Volume 15
Issue 2
Pages: 63-64

By Jim Erickson, Blue Mountain Quality Resources, Inc., pp. 63-64. In the fast-paced biopharmaceutical manufacturing environment, "speed to market" is the hallmark catch phrase. Many companies are focusing only on the processes that add the most value and are outsourcing the rest. This focus on core competencies has some biotech companies reevaluating their calibration practices. Many are contracting more of that workload, from both laboratory and production facilities, to calibration service laboratories.

To view a PDF of this article from the BioPharm International archives, click this link

Articles in this issue
Using a Model and Tools to Standardize the Preparation for a Preapproval Inspection
Using a Model and Tools to Standardize the Preparation for a Preapproval Inspection
Sale of Your Product Can Prevent Patenting: How to Avoid the On-Sale Bar
Outsourcing Outlook: Reaping the Benefits of E-Procurement
The Immunogenicity of Therapeutic Proteins
Analytical Advances: Calibration Management of Outsourced Calibrations
High-Throughput Biopharmaceutical Drug Development: Meeting the Coming Challenge
Inside Washington: Costs and Controls Challenge Manufacturers
21 CFR Part 11: (Un)Expected Added Value
Recent Videos
Lee Cronin, founder and CEO of Chemify
Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech | Image Credit: BioPharm International
Related Content
3d rendering. Empty blank black metal sphere balance scale on white background. | Image Credit: ©PATARA – stock.adobe.com

Comparability in Accelerated or Stressed Stability Studies Using a Quality Range

Richard K. Burdick
December 4th 2024
Article

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

Human cells segregating exosomes. Exosomes are extracellular vesicles, that are involved in physiological processes like coagulation, waste management and intercellular communication. | Image Credit: © Juan Gärtner - © Juan Gärtner - stock.adobe.com

Extracellular Vesicles and Fluorescence Excitation-Emission Matrix Spectroscopy

Lyufei Chen
November 25th 2024
Article

Fluorescence spectroscopy offers unique advantages for characterizing EVs.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Abzena Launches GMP Cell-Based Potency Testing in US and UK Sites, Boosting Analytical Capabilities

Feliza Mirasol
November 22nd 2024
Article

The company will now include GMP cell-based potency assays at its Cambridge, UK, and San Diego, Calif., sites expanding its early and late phase analytical capabilities.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

BioPharmaSpec Launches Three New R&D Facilities in Europe

Feliza Mirasol
November 20th 2024
Article

The new European facilities located in German, Italy, and Lithuania will specialize in drug discovery and R&D services.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Avantor Launches New Innovation Center in New Jersey to Tackle Challenges in Life Sciences

Feliza Mirasol
November 14th 2024
Article

Avantor has launched its new, expanded Innovation Center in Bridgewater, NJ, with integrated workflows under one roof and purpose-built collaboration spaces.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Tosoh Bioscience Opens Expanded Headquarters in Germany

Susan Haigney
November 5th 2024
Article

The expanded offices in Griesheim, Germany, feature a demonstration and training area.

© 2024 MJH Life Sciences

All rights reserved.