Quality

The three pillars of a successful Drug Approval are Efficacy, Safety and Quality. We offer full service to secure highest Quality of your Product.

Selection of Contract Development / Manufacturing Organization – your drug is unique

For a fast and successful development of a drug it is mandatory to select the right partner with broad experience in formulation and specialized drug delivery technologies tailor made for you molecule. Working within a global network of companies with high expertise in drug development, Schaeffler PharmaConsulting will identify the ideal partner to accelerate the development, avoid costly rework and reduce the risks / improve the Clinical outcomes through proprietary formulations dedicated for your drug candidate.

Development of Drug Substance and Drug Product

Development includes all dosage forms needed for Biologics, New Chemical Entities or Life-cycle projects. Main expertise covers solid oral forms, pulmonary and sterile products (both injectable and ophthalmic), modified release products and combination products.

Exploratory / early phase development / Pre-formulation study design

A dedicated exploratory /early phase development program that applies a broad range of pre-formulation testing and technologies will help to bring your drug candidates into first-in-man studies faster.

For New Chemical Entities for example, it is very often needed to overcome the low solubility and /or the low oral bioavailability of your molecule prior to the initiation of a Clinical Study. Therefore, the solubility needs to be improved to maximize oral bioavailability.

Typically, exploratory development of NCE for oral use includes salt synthesis, salt form selection and polymorph screening, further solid / solution state stability and pH and temperature dependent degradation /solubility profile. For the selection of the best formulation also in-depth knowledge on adsorption/desorption and compatibility with excipients and Container/closure compatibility is mandatory.

For formulation research and development of biopharmaceutical drugs such as proteins, peptides, monoclonal antibodies, nucleic acids and vaccines the challenges during development are completely different. Process understanding and formulation expertise, in combination with analytical know-how are key for a successful lyophilizate formulation and process development. Beside others focus is here for example on the stability of your candidate, avoidance of aggregates and retaining the biological activity.

Formulation and analytical method development and manufacturing process development / optimization

During the entire R&D process of your drug candidate, the dose to be administered, the formulation, the analytical test procedure and the manufacturing process need to be adapted and optimized. With the long lasting experience and proven track record, Schaeffler PharmaConsulting will safely navigate your candidate through the following phases:

          PreClinical (GLP toxicology)

          Prototype formulation screening studies

          Investigational Medicinal Product Manufacture for “First in Man” and Phase I –III Clinical studies

          Formulation/process optimization

          Scale-up/technology transfer

          Manufacturing Process validation

          Commercial manufacturing support

The development of the best (ideally proprietary) formulation and manufacturing process for your candidate is our passion to secure

          Best Clinical outcome through ideal drug release profile (modified release dosage forms)

          High stability

          Reproducible, reliable and validated manufacturing processes

          Approval of your Clinical Trial Applications (CTA) and Marketing Authorization Applications (MAA)

We will continuously monitor the different steps during development and advise your company accordingly.

For your late stage formulation “Quality by Design” according the principles of ICHQ8, ICHQ9 and ICHQ10 needs to be applied: As you development candidate is unique, the definition of a Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters and finally of the Control Strategy is key for a successful and fast development and early market entry.

Quality Assurance

We can support you with

          Setting up of a new or working within your existing GMP QA system needed for the conduct of a Clinical Study

          GMP Audits /Inspections at the selected Contract Development/Manufacturing Organization

          Technical / Quality Agreements with your partners

Dr. Achim Schäffler is a “Qualified Person” pursuant to §14 German Drug Law and EU directive 2001/83/EC (article 49).

 

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