Positioning Cell Therapy Manufacturing for Success - Ensuring Quality and Consistency Part I

January 26, 2021

Stem cell therapy is a promising advancement in modern regenerative medicine. Cell therapy manufacturing processes are tasked with creating consistently safe and efficacious drugs for clinical trials and beyond, as healthcare professionals discover new and better ways to use cell therapy to support tissue regeneration and combat exaggerated immune responses. 

Successful cell therapy manufacturing will involve using quality materials to create quality drugs and carefully monitoring variation among products.

How to Identify Critical Quality Attributes and Critical Process Parameters

Critical quality attributes (CQA) and critical process parameters (CPP) are part of process validation, a necessary measure to ensure FDA compliance, manufacturing line productivity, and final product quality. 

CQA refers to the chemical, physical, biological, and microbiological characteristics of a pharmaceutical product that must fall within a range to meet quality standards. During the process design stage, your company should establish satisfactory limits of CQAs.

Deciding upon rules to measure and analyze CQAs in your product is also important to do during the first stage of validation, and you’ll continue to fall back on these protocols throughout cell therapy manufacturing processes down the road. 

CPPs can affect CQA, so it’s important to determine which process parameters are critical during the early stages of product development.¹ CPPs should be strictly controlled and monitored to minimize losses from products that don’t meet your quality standards. 

CPPs may include the pH, rotation speed, cooling rate, or temperature on the manufacturing line.

Determine the Quality Target Product Profile (QTPP)

The QTPP summarizes the product’s attributes that affect its quality. This can include elements like dosage strength and form, delivery system, container, stability, purity, and sterility. You should also consider the safety and efficacy of the product. 

Implementing quality by design (QbD) in cell therapy goes hand-in-hand with QTPP. QbD refers to rigorously testing the quality of your product during early development stages.² Rather than waiting to test your nearly shelf-ready product, testing product quality early can help you identify the underlying causes of current or potential quality issues. 

Most of the time, QbD requires you to pinpoint causes of variability within the product development that could cause inconsistencies and quality issues. 

Respond to Variability

There is tremendous variability in cell therapies, which comes with benefits as well as negative implications for product consistency.³ While donor variability can improve the accessibility of materials necessary for cell therapy manufacturing, it can ultimately lead to product variability. This, in turn, can lead to inconclusive clinical trial results and products that are only sometimes effective or safe.

Reducing the variability in your product or service is an important key to quality control. The donor is the primary source of variability in stem cell products, so standardizing products requires technologies that can purify the stem cells at the time of collection and down the road. 

As your stem cell material progresses through the collection, purification, and processing steps, it’s important to monitor the steps and prevent unnecessary complications and variations that could impact the final quality of the product. There is more time and distance between the steps of stem cell therapy manufacturing than other manufacturing processes, making a comprehensive understanding of CPP all the more important. 

High-Quality Cell Therapy Products Start with High-Quality Raw Materials

Quality stem cell therapies start with quality collection. This means your collections should strike the delicate balance of retrieving yields large enough to be useful while still remaining pure enough for consistency purposes. 

Planning according to prospective client quantity needs should account for expected losses during cell purification and manufacturing processes necessary for cell therapy product production. 

The Cell Therapy Manufacturing Process

After starting with high-quality material, strong and standardized manufacturing processes are necessary to promote product quality and consistency. Cell therapy manufacturing companies are responsible for ensuring quality from collection to production to shelf life. 

Allogeneic cell therapy manufacturing promotes consistency by using a single cell source to create a cell bank to be used in all the cell therapy products.⁴ 

Implementing GMP-compliant processes and following the regulatory guidelines can help manufacturing companies keep their products consistent.  

Outsource to a Certified Manufacturing Organization

Many pharmaceutical companies work with CDMOs to create high-quality products that meet regulatory standards and improve patient outcomes. A CDMO can take over the manufacturing processes from early development to clinical trials to aseptic fill and finish. 

Final Thoughts

BioStem Life Sciences is an experienced cell therapy manufacturer. We’ve worked with biomedical research institutions and pharmaceutical companies to create products for clinical trials and scalable production. 

To learn about how our proven manufacturing processes can support the consistency and quality of your stem cell therapies, contact our sales team.


(1) Loewe, Daniel, et al. "Forced degradation studies to identify critical process parameters for the purification of infectious measles virus." Viruses 11.8 (2019): 725.

(2) Lipsitz, Yonatan Y., Nicholas E. Timmins, and Peter W. Zandstra. "Quality cell therapy manufacturing by design." Nature Biotechnology 34.4 (2016): 393-400.

(3) Osafune, Kenji, et al. "Marked differences in differentiation propensity among human embryonic stem cell lines." Nature biotechnology 26.3 (2008): 313-315.

(4) Pigeau, Gary M., Elizabeth Csaszar, and Aaron Dulgar-Tulloch. "Commercial scale manufacturing of allogeneic cell therapy." Frontiers in medicine 5 (2018): 233.

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