Successful Steps for Outsourcing the Manufacture of Clinical Trials Materials - To map a smooth road to the clinic, consult early with your manufacturing partner about the trial design, location,


Successful Steps for Outsourcing the Manufacture of Clinical Trials Materials
To map a smooth road to the clinic, consult early with your manufacturing partner about the trial design, location, size, and timelines.

BioPharm International

An area often overlooked in considering the final product container is the issue of filling validation. If the clinical trial material is to be supplied by the CMO in its final dosage form, then the CMO must undertake a filling validation to provide assurance that it is able to fill the requisite number of containers in an aseptic manner. The validation must also demonstrate that the correct volume of product is dispensed into each container, within an agreed and defined tolerance level.

Conflicting Demands of Robustness and Speed

There are always lively discussions between process development professionals and those on the business side who are overseeing the clinical development. It is understandable that the sponsoring company will be anxious to deliver the clinical trial material to the clinic as fast as possible. Many biopharmaceutical companies' entire business model is based on speeding a therapeutic candidate into the clinic as quickly as possible to establish the safety of the product and to confirm proof of principle, with the intention of partnering with a larger pharmaceutical organization to take the candidate forward into later-phase clinical trials (and hopefully through to commercial manufacture).

Compounding this need for speed is the fact that regulatory authorities do not insist on manufacturing early-phase clinical trial material using a fully validated manufacturing method. Everyone knows that validation will need to be performed for later-phase clinical trials (and certainly for commercial manufacture), but it can be tempting to avoid any extraneous expense and time in process development for a Phase 1 clinical trial.

The antidote is to use the services of the Qualified Person (QP) within the CMO to prepare for a clinical trial. The QP will help ensure that compliance is built into the manufacturing process for clinical trial material and avoid any nasty surprises with the regulators. The QP can advise on whether the proposed manufacturing strategy and proposed design of the clinical trial will be likely to be acceptable to the regulatory authorities.

Working with a QP will ensure that the trial design and manufacturing are appropriate for the stage that the therapeutic candidate has reached. The payoff is that you avoid any nightmare scenarios in which a sponsor has gone through cGMP manufacture of clinical trial material, but regulators have picked up some issue with regard to manufacturing, testing, or packaging that cannot be resolved. In the worst case, this could lead to the need to remanufacture the whole clinical trial investigational medicinal drug product, which would be a catastrophic waste of money and time.

Susan Cameron is a commercial scientist at BioReliance, Ltd., Glasgow, UK, +44.(0).141.579.3265,


1. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J Eur Communities 2001 Jan 5; L121:34-44.

blog comments powered by Disqus



Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
November 26, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
Author Guidelines
Source: BioPharm International,
Click here