Amgen biotechnology manufacturing quality iconQuality from the start

High-quality and reliable biotech manufacturing is every bit as important as scientific innovation. The significant investment Amgen has made in state-of-the-art manufacturing facilities, robust processes,1,2 and an experienced and engaged workforce reflects our unwavering commitment to excellence in biotech manufacturing.

Amgen maintains this commitment because seriously ill patients count on our medicines for their treatment. The characteristics of biologic medicines are closely related to manufacturing processes and environmental conditions.3 With this in mind, Amgen builds in quality, beginning with the design of medicines, all the way through to their development, manufacturing, and distribution to patients. We include more than 250 quality checks and perform in-depth analysis of our manufacturing performance to continuously improve it.4

  1. Amgen Continues Manufacturing Expansion with Additional $1 Billion Investment in Puerto Rico. Press release. February 2006.
  2. Amgen to Make Significant Investment in Manufacturing, R&D and Commercial Operations Expansion. Press release. January 2006.
  3. Herman AC, Boone TC, Lu HS. Characterization, formulation, and stability of Neupogen (Filgrastim), a recombinant human granulocyte-colony stimulating factor. Pharm Biotech 1996;9:303-328.
  4. Data on file, Amgen; 2014.

Quality in action

Quality by Design (QbD) is a set of principles adopted by Amgen to ensure quality control in the manufacturing process. It's part of a regimen of important processes Amgen has developed to produce and deliver high-quality products that are both safe and compliant with regulatory requirements.

Amgen scientist preparing samples in the Chemistry lab.

Delivering High-Quality Products Through Quality Processes

Amgen, either independently or in collaboration with industry peers, has developed important processes for producing high-quality products in compliance with regulatory requirements. Additionally, Amgen has adopted the Quality by Design (QbD) principles, which further integrate quality control into the manufacturing process.1

For QbD, the product and process knowledge base must include an understanding of variability in raw materials, the relationship between a process and product’s critical quality attributes (CQAs), and the association between CQAs and a product’s clinical properties. Successful implementation of QbD concepts requires cooperation across a multitude of company teams, from R&D to manufacturing to quality control and regulatory affairs.2 By utilizing QbD principles and adhering to regulatory requirements, Amgen follows a systematic approach to the development of its medicines that begins with predefined objectives and emphasizes extensive product knowledge, process understanding and process control, based on sound science and quality risk management.1

Knowledge and experience gained from previous biologic medicine development is utilized to create a list of CQAs. Potential impacts on CQAs comprise many elements, including formulation components (excipients, buffer components, surfactant, raw materials impurities, and protein concentrations), solution conditions (pH, temperature, ionic strength), process conditions (freeze/thaw, transportation, photo exposure, mixing, hold time, ultrafiltration/diafiltration, filtration, filling, lyophilization, inspection), and components (IV bags, tubings, vials, syringes, stoppers, devices) is created and the effects of these parameters on CQAs are then studied. This knowledge and expertise allows Amgen to identify and understand quality variability during process development so they can be measured and controlled in real-time during manufacturing.1

Understanding the impact of attributes of aggregates/particulates in monoclonal antibody-based formulations on potential biomarkers of the innate and adaptive immune responses are important predictors of the potential immunogenicity of aggregates/particles in biotherapeutics.3 Given the association between protein aggregation (intrinsic to manufacturing and storage of biotherapeutics) and the increased risk of immunogenicity, Amgen scientists established a series of quality target profiles and continue to investigate the process inputs most likely to impact these attributes.

  1. Jameel F, Khan M. Am. Pharm. Review 2009.
  2. Rathore AS. Nat Biotechnol 2009.
  3. Joubert MK, Hokom M, et al. J Biol Chem 2012; 287(30).
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