Akron at Phacilitate 2015: Raw Materials Control for Bioassay Consistency

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From 26-28 January, Akron attended the 11th Annual Phacilitate’s Cell and Gene Therapy Forum, which brings together bioleaders from the regenerative medicine and cell therapy fields to discuss issues relating to manufacturing, product characterization, logistics, R&D and regulatory challenges and outline paths forward for the industry.

Akron’s Dr. Claudia Zylberberg participated in the Manufacturing and Product development panel sponsored and chaired by Dr. Jiwen Zhang from GE Healthcare alongside Margarida Menezes Ferreira, Member of the Committee for Advanced Therapies (CAT), and of the Biologics Working Party at the European Medicines Agency (EMA) and Robert Preti, PhD., President of Progenitor Cell Therapy (PCT) and CEO of Neostem.

Questions discussed included process compatibility when moving from 2D to 3D cell culture, considerations and insights into serum-free processing options, new developments in 3D bioprinting for the production of personalized tissues or organs for transplantation.

One important topic that the panel also discussed is raw material control and compliance from a regulatory and manufacturing  point of view. Quality standards needed for raw materials used in a process vary for different regulatory agencies. For instance, the EMA does not have drug master files like FDA does in the US.

Akron Biotech has long championed the critical importance of raw material qualification, and at Phacilitate, we discussed at length the implications that such control – or the lack thereof – has.

Raw materials for cell therapy are in itself a complex concept and it is recommended that a minimum Quality Managment System be in place to control and allow traceability. The requirements that will allow compliance and assist with the claims of the final cellular product should be agreed between the manufacturer and the user. The main issue with biological raw materials is consistency and performance, which makes qualification of batches critical.

Akron’s stance on raw material control and its implications on bioassay also stresses some important points:

Because cell therapy products are often linked to the biological performance of a living entity often characterized in terms of a biological assays (such as for cytokines and growth factors), the implications of bioassay consistency is important.

When developing cytokine bioassays, while raw material control is important, it is not the only determining factor for cytokine activity.

Bioactivity of cytokines depends on two main factors:

  • Consistency of raw materials
  • Cell behavior in culture and assay

Users should, firstly, ensure that raw materials and the corresponding suppliers are qualified across multiple batches and that, at the time of use, there is consistency in age and nature of the raw material.

Having said this, while consistency in raw materials helps ensure consistent cell processing, raw material consistency does not in and of itself guarantee consistent cell behavior.

Cells respond to multiple factors – raw materials being one – when in culture. These are protocol-related (such as manual processing), age of the cells, freeze/thaw conditions, environmental conditions and many more.

Finally, the bioassay conditions, which involves both cells and cytokines as well as assay materials, must be qualified in the same way – this includes everything from assay reagents qualification, instrument calibration, to data analysis, to reaction conditions control and finally analytical equipment maintenance.

In short, users should ensure raw material consistency by strictly qualifying all materials, but also be aware that the same level of control must be maintained across the entire process.Contact us to learn more : info@akronbiotech.com

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