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How can you purify biopharmaceuticals more effectively?

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Biopharmaceuticals are drugs derived from biological sources, such as cells, tissues, or microorganisms. They have many applications in medicine, such as vaccines, antibodies, hormones, and enzymes. However, biopharmaceuticals are also complex and sensitive molecules that require careful purification to ensure their quality, safety, and efficacy. In this article, you will learn about some of the challenges and strategies for purifying biopharmaceuticals more effectively.

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Paul Palmer

Helping Head of Quality / Quality Directors Transition from Crisis Managers to Strategic Leaders with the Core…
Meghal Mistry

General Manager | Business Development & Strategy Lead for Biosimilars, Vaccines, and Novel Assets | Driving Growth…
Abd Hannan B. Abd Rahman, MSc, AMRSC, AMIChemE

Graduate Process Engineer at Aibel Singapore Offshore Oil and Gas Company || MSc Chemical Engineering Graduate of…

1 What are the main goals of biopharmaceutical purification?

The main goals of biopharmaceutical purification are to isolate the desired product from the impurities and contaminants that are present in the production process. These impurities and contaminants can include host cell proteins, DNA, endotoxins, viruses, and aggregates. They can affect the stability, activity, immunogenicity, and pharmacokinetics of the biopharmaceutical, as well as pose health risks to the patients. Therefore, biopharmaceutical purification aims to achieve high purity, yield, and recovery of the product, while minimizing the cost, time, and environmental impact of the process.

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Abd Hannan B. Abd Rahman, MSc, AMRSC, AMIChemE

Graduate Process Engineer at Aibel Singapore Offshore Oil and Gas Company || MSc Chemical Engineering Graduate of National University of Singapore || Volunteer at Singapore Red Cross Humanitarian Youth Organization
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The true objective of purification is to enhance the product's safety while preserving its effectiveness within the market. The danger of using any pharmaceutical treatment is weighed against the potential advantages of using that medicine. It will never be used if the potential danger is greater than the potential advantages. It is necessary for purification to have the ability to tilt the balance of these features in order for the product to be worth applying.

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Paul Palmer

Helping Head of Quality / Quality Directors Transition from Crisis Managers to Strategic Leaders with the Core Competence System | LMS | PQS | GxP
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The real goal of purification is to improve safety while retaining efficacy of the product. Any medicinal product is judged based on the risk versus benefits of use. If the risk is higher than the benefits it will never be used. Purification must be able to tip the balance of these characteristics to make it worthwhile using the product.

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2 What are the main steps of biopharmaceutical purification?

The main steps of biopharmaceutical purification are capture, intermediate purification, and polishing. Capture is the first step that separates the product from the bulk of the impurities and contaminants in the crude feed stream. This step usually uses a chromatographic technique, such as affinity chromatography, that exploits the specific binding properties of the product. Intermediate purification is the second step that further removes impurities and contaminants that are similar to the product in size, charge, or hydrophobicity. This step usually uses a combination of chromatographic techniques, such as ion exchange chromatography, hydrophobic interaction chromatography, or size exclusion chromatography. Polishing is the final step that eliminates any remaining traces of impurities and contaminants that can affect the quality and safety of the product. This step usually uses a filtration technique, such as ultrafiltration, diafiltration, or virus filtration.

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Paul Palmer

Helping Head of Quality / Quality Directors Transition from Crisis Managers to Strategic Leaders with the Core Competence System | LMS | PQS | GxP
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It's true these are the main steps, however any individual drug substance is processed by selecting the techniques which are effective. Biopharmaceuticals are special since they vary so much its often difficult to select the right options. Therefore analysis of the output is an important part of the qualification when selecting which technologies to use in each step.

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3 What are the main challenges of biopharmaceutical purification?

The main challenges of biopharmaceutical purification are the complexity, diversity, and variability of the biopharmaceutical products and the impurities and contaminants. Biopharmaceutical products can have different structures, functions, and properties, depending on their source, expression system, and post-translational modifications. Impurities and contaminants can also vary in their nature, quantity, and quality, depending on the production process, culture conditions, and downstream operations. These factors can affect the performance, selectivity, and robustness of the purification methods, as well as the scalability, reproducibility, and regulatory compliance of the process.

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Paul Palmer

Helping Head of Quality / Quality Directors Transition from Crisis Managers to Strategic Leaders with the Core Competence System | LMS | PQS | GxP
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The main challenge in the purification of Biopharmaceuticals is removing the unwanted contaminants and potential infectious agents without reducing the efficacy and potency of the drug substance. The process isn't as simple as that used in a small molecule. For example ; a sterilising filter could remove the drug substance and disrupt the conformational structure rendering the product non-viable.

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4 What are some of the strategies for purifying biopharmaceuticals more effectively?

Some of the strategies for purifying biopharmaceuticals more effectively are to optimize the upstream and downstream processes, to use novel and innovative purification methods, and to implement quality by design and process analytical technology principles. Optimizing the upstream and downstream processes can reduce the impurities and contaminants in the feed stream, improve the product yield and quality, and enhance the process efficiency and productivity. Using novel and innovative purification methods can increase the specificity, capacity, and resolution of the separation, as well as reduce the cost, time, and waste of the process. Implementing quality by design and process analytical technology principles can enable the systematic design, monitoring, and control of the process, as well as the identification and mitigation of the critical process parameters and quality attributes.

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Paul Palmer

Helping Head of Quality / Quality Directors Transition from Crisis Managers to Strategic Leaders with the Core Competence System | LMS | PQS | GxP
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The simplest strategy to make purification more effective is testing options of the parameters used. For example pH is often critical similarly osmolality even processing temperature. These need to be verified as part of QBD to get the right combination to ensure the product remains viable.

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Meghal Mistry

General Manager | Business Development & Strategy Lead for Biosimilars, Vaccines, and Novel Assets | Driving Growth, Innovation, Licensing and Strategic Partnerships
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Leveraging novel chromatography and selective downstream purification approaches in the production of biological products represents a paradigm shift in enhancing efficiency and product quality. Take monoclonal antibodies (mAbs) production as a case study. Selective downstream purification approaches, like affinity chromatography tailored to the specific properties of the target molecule, enable a more streamlined and efficient process. For instance, Protein A chromatography is commonly employed for mAbs purification due to its high specificity for antibodies. This strategic use of advanced methods not only improves the purity but also contributes to cost reduction by minimizing the number of steps and resources required in the downstream.

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5 How can you learn more about biopharmaceutical purification?

If you are interested in learning more about biopharmaceutical purification, you can explore various online and offline resources, such as books, journals, courses, webinars, podcasts, and blogs. You can also network with other professionals and experts in the field, such as chemical engineers, biochemists, biotechnologists, and pharmacists. You can also participate in industry events, such as conferences, workshops, symposia, and exhibitions. By learning more about biopharmaceutical purification, you can enhance your knowledge, skills, and career prospects in this rapidly growing and evolving sector.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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How can you purify biopharmaceuticals more effectively?

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1 What are the main goals of biopharmaceutical purification?

2 What are the main steps of biopharmaceutical purification?

3 What are the main challenges of biopharmaceutical purification?

4 What are some of the strategies for purifying biopharmaceuticals more effectively?

5 How can you learn more about biopharmaceutical purification?

6 Here’s what else to consider

Chemical Engineering

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