Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative
approach. The author analyzes a project for an injectable drug for which a new drug application was submitted to FDA. The
project required collaboration in development, manufacturing, and technology transfer; resource allocation of scientific and
manufacturing staff; project management; and the resolution of related technical issues.
A generic injectable drug was to be developed and manufactured in two strengths and supplied in flexible bags for sale in
Canada, Australia, Europe, and the United States. The client planned to submit a new drug application (NDA) for FDA approval.
This submission required demonstrating to FDA that the contract manufacturing organization (CMO), Laboratorios Grifols, was
capable of manufacturing highly safe medicines of the quality demanded by the US market. The challenge of manufacturing a
product that would be submitted for FDA approval involved adapting the existing quality system to FDA requirements.
All the CMO production facilities had implemented the same quality management system (QMS), and parametric release was authorized
in 2007. The QMS includes European Medicines Agency (EMA) GMPs for medicines, ISO certifications, and FDA GMPs for medical
devices. The challenge was to incorporate FDA GMPs for medicines into the QMS with as little upheaval as possible. The dilemma
was adapting the QMS to FDA requirements concurrent to developing the medicine, which required teamwork between R&D, manufacturing,
and quality assurance departments to, for example, improve master batch records, implement changes in manufacturing procedures,
and improve deviation management.
Fortunately, the FDA inspection of the CMO’s facilities did not require the company to modify any of the production processes,
other than those modifications already contemplated for the project. Some secondary non-crucial working procedures did require
some adjustments, which were completed over a two-month period.
Establishing the team
One of the major hurdles required Grifols to be flexible and to incorporate the client’s requirements with a minimum impact
to the company’s own structure and working procedures. This meant adapting to the customer without compromising the company’s
own work philosophy. Third-party project management requires the same amount of dedication and commitment as for one of the
company’s own products, because this is the only way to transmit integrity, inspire confidence, and establish clear and honest
communication with the client.
Grifols needed to bring together a multi-disciplinary team of professionals. Each member of the team would have to be highly
flexible and fully committed to the assignment; they would need to adopt a proactive attitude, have the ability to recognize
the pitfalls that would inevitably arise, and provide adequate solutions. The first step was to decide upon a team that would
guarantee agile communication with the client and that would respond effectively throughout the different stages of the project
from the early development stages to placing the product in the market. The team included the following profiles: