WHY GRIFOLS

What sets us apart from other CDMOs?

Grifols Partnership stands out from other CDMOs through our commitment to the well-being of patients and their quality of life. Safety is elevated above regulatory obligation and is coupled with our holistic approach to quality. This Grifols philosophy encompasses not just our products, but also permeates our internal manufacturing, communication, and operational procedures.

Our commitment to quality has engendered a robust, dependable quality system, establishing Grifols Partnership as an ideal strategic partner.

Our Philosophy in Action:

  • A vertical integration model, which allows us to oversee the entire process from inception, ensuring the highest quality standards for our partners.
  • In-house development and production of flexible bags which delivers the perfect match between a drug and its container.

Safety through Quality

We manufacture our products to stringent GMP standards and the requirements of the US and European Pharmacopeia, targeting excellence in the finished product.

The production of sterile parenteral products requires not only a culture of quality, but effective quality systems to consistently meet the highest safety standards. Our culture of quality is reflected in our commitment to continuous improvement, and underscored by our integration of quality into manufacturing processes from the outset.

Adhering to a quality-by-design (QbD) methodology and complying with parametric release requisites stand as two pillars of a successful and effective quality program.

Safety, Quality and Efficiency

While safety and quality are central to everything we do, our partners also demand efficiency. Our innovative manufacturing processes substitute inefficient manual operations with extensively automated, multifaceted processes which elevate quality and increase productivity.

Quality Control

Activities performed at each production site

We work diligently to ensure the highest levels of quality in our production processes. A team of more than 60 professionals at our sites manages quality control activities through the Quality Control Area.

Murcia Site

  • WFI and environment monitoring
  • Plastic materials control
  • Bioburden
  • In process control
  • Secondary packaging materials

Barcelona Site

  • Raw materials control
  • APIs control
  • Bioburden
  • Primary and secondary packaging control
  • Final product control
  • In process control

Accreditations

We continually enhance our quality systems, earning top accreditations and certifications. Grifols secured AEMPS authorization for parametric release of parenteral solutions in glass and flexible containers at our Spanish manufacturing plants, making us a European pioneer in this achievement.

  • EMA
  • FDA
  • UE GMP
  • FDA GMP
  • GMP Canada
  • ISO 13485
  • ISO 14001
  • ICE
  • Parametric release

Parametric Release for Sterility

Parametric release ensures product quality through data collected during manufacturing, complying with good manufacturing practices. Our rigorous quality system at Laboratorios Grifols earned us this recognition, guaranteeing product sterility without additional sterility tests.

Safety isn't just regulation, it's our philosophy at Grifols. It applies to our products and internal processes, from manufacturing to communication.

Enhanced Quality Control through Vertical Integration

Grifols Partnership exemplifies the advantages of vertical integration with form-fill-seal technology. This automated process creates polypropylene containers (bags) by forming, filling, and sealing them in a single step, free from human interaction. Grifols manufactures components like ports and stoppers, and employs equipment developed by Grifols Engineering to ensure complete control.

Grifols Engineering

Grifols Engineering, a subsidiary of Grifols, designs pharmaceutical production facilities, processes, and machinery for Grifols and other pharmaceutical manufacturers. As part of a pharmaceutical company, it possesses deep knowledge of quality and compliance requirements for pharmaceutical production and facility design.

Through vertical integration, Grifols maintains end-to-end control, ensuring uniform high-quality standards throughout the manufacturing process. This dedication to quality extends across all company activities.

Expertise in Injectable Drugs

Grifols is a leader in the Spanish pharmaceutical market for large volume parenteral solutions. The company has over 100 years of experience in the parenteral solutions field.

Experts in development and contract manufacturing (CDMO), with long-standing satisfied customers.

Experts in formulation, filling, terminal sterilization, labelling and packaging in flexible container (PP bags) and vials.

Our Services and Capabilities

Our Team

Grifols' history reflects a team that has grown with new members joining our project. While some contributions to the team are particularly decisive, the final outcome results from the cooperation and teamwork of everyone at Grifols.

We take pride in being part of a company where honesty guides decision making, and where we each contribute to Grifols' reputation in society.

Oriol Prat

Director Contract Manufacturing &
IV Solutions

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Marga Viñes

Senior Business Development Manager
Contract Manufacturing

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Estela Llorens

Director of Research & Development

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Marta Serra

Technical Director Laboratorios Grifols

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Ricardo Bernabé

Director of Manufacturing Murcia Facility

Oriol Argemí

Managing Director Laaboratorios Grifols

Lluc Mercadé

Director of Manufacturing Facility in
Parets del Vallés

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Àngels Romero

Director of Finance Laboratorios Grifols

Carla Mössinger

Business Development Manager
Contract Manufacturing

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Our Approach to Customers

Grifols Partnership actively pursues projects with small, big, and emerging pharma companies, spanning human and veterinary markets, both globally and domestically.

Successful project completion hinges on aligning commercial strategies between organizations which is why we provide integrated project management for product development and supply.

Our team includes experts from all relevant areas who implement new processes and products at manufacturing sites. We meticulously plan and track each project, ensuring you are informed every step of the way.

Our Flexibility

We understand that what works for one company may not suit another. We are solutions focussed, providing insights into how process or product design changes can affect final product acceptance.

This knowledge is valuable for drug manufacturers looking to distinguish their small molecule parenteral products, whether introducing a new branded therapy in a glass vial or extending the life cycle of a generic premixed solution in flexible plastic packaging.

Supporting Partners at all Stages

Pharmaceutical and Analytical Development

  • Selection of ingredients and container closure system
  • Manufacturing and sterilization process development
  • Pharmaceutical development studies
  • Analytical and microbiological method development and validation
  • Analytical transfer and verification
  • Stability studies

Scale-up, Engineering and Registration batches

  • Scale-up and manufacturing engineering batches
  • Sterilization process validation
  • Compatibility studies
  • Manufacturing of clinical and registration batches
  • Manufacturing process validation
  • Container closure integrity
  • Risk assessment procedures (elemental impurity, residual solvent, nitrosamines)
  • ICH stability studies
  • Shipping studies

Commercial Manufacturing

  • Analytical control (raw materials, in process control, final product)
  • Commercial manufacturing of industrial batches (small and large scale)
  • Labelling and packaging
  • Batch record review
  • Analytical and conformance certificate
  • Serialization
  • On going stabilities

Regulatory compliance

As outlined above, we oversee every process step, including regulatory compliance. Grifols Partnership includes regulatory support in our sterile contract manufacturing solutions, supplying customers with technical documentation, safety sheets, and certificates of analysis for registration in selected markets.

Contact our experts to discuss your manufacturing needs.

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