Operations and Quality Oversight of CMOs

Publication
Article
BioPharm InternationalBioPharm International-05-15-2017
Volume 2017 eBook
Issue 1
Pages: s4-s7

Effective communication between contract manufacturing organizations and pharmaceutical company clients relies on well-defined master service and quality agreements.

CMO partnerships can be challenging both for the CMO and the product owner. The article maps out optimal organizational designs for CMOs and product owners that increase the likelihood of a successful partnership and ensure consistent, reliable, and quality supply of drug product.

 

Download BioPharm International's

2017 Outsourcing Resources eBook

.

 

 

 

 

Articles in this issue
Wellspring_225.jpg
Customer Relationship Management in Contract Manufacturing
ColdChain_225.jpg
Preparing an Approach to Cold Chain for Cell- and Tissue-Based Therapies
TechTransfer_2251495479190893.jpg
Getting Biopharmaceutical Tech Transfer Right the First Time
CMOs_225.jpg
CMOs Tackle New Challenges
Biosimilars_225.jpg
Gearing Up for Biosimilars
InsourcingOutsourcing_225.jpg
Insourcing vs Outsourcing: Choosing the Right Strategy
Operations_225.jpg
Operations and Quality Oversight of CMOs
QualityMetrics_225.jpg
Quality Metrics and CMO Agreement
Audits_225.jpg
Key Considerations in Outsourced “On-Site” Audits as Part of Supplier Qualification
Recent Videos
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Related Content
Cancer in the blood outbreak and treatment for malignant cells in a human body caused by carcinogens and genetics with a cancerous cell as an immunotherapy and leukemia or lymphoma symbol and medical | Image Credit: © freshidea - stock.adobe.com

Multiple Myeloma Treatment from Regeneron Gets FDA Accelerated Approval

Patrick Lavery
July 2nd 2025
Article

Linvoseltamab-gcpt, marketed as Lynozyfic, is a bispecific antibody designed to facilitate T cell activation and cancer cell killing.

Drug Solutions Podcast: Considering Biologic Drug Development and Manufacturing Holistically

Drug Solutions Podcast: Considering Biologic Drug Development and Manufacturing Holistically

Felicity Thomas
May 25th 2023
Podcast

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

EDQM Announces Digital Version of the European Pharmacopoeia

Susan Haigney
June 26th 2025
Article

EDQM is providing the 12th edition of the European Pharmacopoeia as an all-digital, redesigned, user-friendly issue.

BIO 2025: Speeding Up Development of Next-Generation Biologics

BIO 2025: Speeding Up Development of Next-Generation Biologics

Patrick Lavery
June 23rd 2025
Article

Matthew Stober and Campbell Bunce of Abzena talk about the CDMO’s role in accelerating the path of newer and more effective modalities to market.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

EMA Conditionally Authorizes Stem Cell Therapy for Blood Cancers

Susan Haigney
June 23rd 2025
Article

The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).

UAE flag waving in the sky, national symbol of UAE | Image Credit: © Freelancer - stock.adobe.com

Abu Dhabi Health Department's US Mission Yields Multiple Strategic Agreements

Patrick Lavery
June 20th 2025
Article

The department’s newly announced partnerships were part of a weeklong visit that included discussions held at BIO 2025.

© 2025 MJH Life Sciences

All rights reserved.