Drug Substance manufacturing scale-up and first GMP production

Scope of work:

Chemistry Manufacturing Control Drug Substance development Project management Selection and supervision over a CDMO

The project focused on the scale-up and manufacturing of a lead molecule’s Drug Substance to support initial clinical development.

Implementation of a Quality Management System at a pre-clinical pharmaceutical company

Scope of work:

Project management Quality Management System

The project involved creating and implementing a new QMS for a pre-clinical pharmaceutical company.

Preparation of complete Modules 3.2.S. and 3.2.P. for a clinical phase 1 drug (IND filing at the US FDA)

Scope of work:

Chemistry Manufacturing Control Drug Substance development IND and IMPD for Clinical Phase Project management Selection and supervision over a CDMO

The project involved authoring and compiling the complete Module 3 for an innovative drug candidate.

Modernisation of the formulation development laboratory and the pilot plant

Scope of work:

Project management Quality Management System

The project aimed to reconstruct and modernise the GMP pilot production area and the formulation development laboratory with a total area of approximately 1,000 to 1,200 m2

Managing the development of the drug substance route of synthesis and manufacturing process for an innovative molecule in the preclinical phase

Scope of work:

Chemistry Manufacturing Control Formulation development Project management Selection and supervision over a CDMO

The project involved developing a manufacturing method for a drug substance that is a candidate for an innovative drug product.

Feasibility study for the use of 3D printing in the drug product manufacturing

Scope of work:

Formulation development Project management

The project involved examining the possibilities of using 3D printing in pharmaceutical technology.

Scale-up and implementation into commercial production of a technologically complex drug product.

Scope of work:

Formulation development

The project concerned scaling up and implementing the production of an oral film-coated tablet. Technical difficulties resulted primarily from the specific properties of the active substance, which constituted approximately 90% of the tablet composition.

Drug product formulation development with the protection of intellectual property.

Scope of work:

Formulation development Project management

The project included developing an oral delayed-release capsule (enteric).

Selected projects