Manufacturing Science & Tech Transfer

Manufacturing Science & Tech Transfer

We offer services to clients around Denmark and Europe within the area of Manufacturing Science & Tech Transfer.

Our expertise spans technology transfers and manufacturing scale-up, with a deep understanding of process science disciplines in biologics manufacturing, including quality control and cell bank management. We offer strategic consulting for agency interactions, support in CMO selection, regulatory document preparation, and in-plant assistance. Our team is skilled in manufacturing investigations, root cause analyses, manufacturing optimization, PPQ preparation and execution, microbial hold strategy assessments for process intermediates, chemical stability evaluations, comprehensive process data reviews, and thorough protocol and PPQ report assessments. Our comprehensive approach ensures quality, efficiency, and regulatory compliance in biologics manufacturing.

CIP/SIP Validation Specialist/Engineer

Our pharma experts provides service bridging all stages

We work closely with our clients to ensure that all quality related activities are carried out viably and effectively. We have In depth knowledge of:

      • Technology transfers and Manufacturing scale up
      • All process science disciplines involving biologics manufacturing
      • Quality control activities
      • Cell bank related work
      • Strategizing and consultation related to agency requests
      • We can support disciplines including 
      • CMO selection and assessments
      • Regulatory filing documents
      • Ad hoc person in plant, manufacturing investigations and root cause analyses
      • Manufacturing optimization activities
      • PPQ preparation and execution strategy including process intermediate microbial hold strategy
      • Process intermediate chemical stability
      • Process data review; Protocol review and PPQ report review/data review
      • Oversight of small-scale studies e.g. SDMQ; hold time studies, process characterization, resin life-time studies
      • Combination of Engineering, Quality, Compliance and MSAT support is an option

Contact Aptio Group

Do you need assitance in any area of quality and compliance? We’ve got you! Whether it is short or long term, do not hesitate to get in contact with us. Our consultants provide high quality services tailored to pharmaceuntical industry.

Fill out the form and we will get back to you as soon as possible.

Next Section: Medical Devices

Read more about our services within the area of Medical Device