MACS® GMP quality

MACS GMP quality

  • Compliant manufacture of cellular products according to GMP guidelines
  • Optimized combination of the CliniMACS® System with MACS GMP Products
  • Over 14 years of trusted experience in GMP manufacturing
The quality of starting materials dramatically influences the properties of the final cellular product. For the development of applications involving cellular therapies, strict procedures according to GMP guidelines are mandatory. All materials used, such as antibodies, antigens, cytokines, cell culture bags, and cell culture media, must comply with GMP specifications. 
Video

MACS GMP Products

Invest in your clinical research by using from the very beginning. A seamless transition between basic and clinical research avoids revalidation and saves time. Watch the video to learn more about Miltenyi Biotec’s world-class GMP manufacturing facility at Teterow in Germany.

Overview of GMP guidelines

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Webinar

GMP 101

Join Dr. Nicolas Danzenbächer and his webinar on Good Manufacturing Practice, explaining the guidelines in different countries and comparable regulations.

Complete manufacturing solutions

Complete manufacturing solutions
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Advanced integrated solutions to streamline cell processing workflows from sample preparation over cell separation, through cell culture to the final cellular product.



Highest standards

MACS® GMP Products are manufactured and tested under a quality management system (ISO 13485) and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. 
Every processing step from development to production and quality control (QC) testing is extensively documented.

  • Lot-to-lot consistency
  • Extensive stability studies
  • Assured supply
  • Vendor qualification of raw materials

MACS GMP Products support the transition from research to clinic and help make cell therapies a clinical reality.

Controlled processes

Our products are manufactured using the highest quality standards

Standardized and strictly controlled industrial manufacturing processes are followed, including automated aseptic filling, lyophilization, and finishing. All steps, from master cell banks to final filled products, are carried out on qualified equipment by qualified and skilled employees.

  • Produced in a modern GMP-certified facility, including a full quality management system according to ISO 9001 & ISO 13485
  • EU GMP certificates for manufacturing of monoclonal antibodies (phase I/II), infusion solutions and aseptic filling
  • FDA-inspected for the CliniMACS® CD34 System

Extensive QA and QC

Extensive quality assurance (QA) and quality control (QC): MACS® GMP Products are manufactured and tested under a certified ISO 13485 quality system. Stringent quality control tests are performed

The product-specific documentation includes:

  • Package Insert
  • Batch-specific Certificate of Analysis (CoA) including animal component free statement
  • Certificate of Origin (CoO)/TSE (transmissible spongiform encephalopathies)
  • Product Information File (PIF) and/or Master File cross reference for select products

Support and expertise

As an experienced provider of products for regenerative medicine and tools for cell therapy applications, Miltenyi Biotec caters to our customers’ needs with technical and regulatory support and long-term perspectives.

USA 
Type II Master File or Safety Master File (for cross-reference) for select MACS® GMP Products

Worldwide (ex USA)
Regulatory Support File (equivalent to Master File, for cross-reference

Company Information and Quality System
Self Survey and Customer Questionnaires as part of a customer vendor qualification program

Expert consultation
Miltenyi Biotec actively interacts with regulatory agencies and notified bodies. Please ask us about customized support for your clinical study.

For complete regulatory notices click here.

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