Considerations for Choosing a Protein Production Service Provider

Protein production, whether generating proteins using bacteria, yeast, insect cells, or mammalian cells, is a complex process that presents a number of challenges including incomplete processing, post-translational modifications, and protease susceptibility. Protein production service providers have extensive experience manufacturing proteins under precise guidelines and are increasingly utilized by biotech and pharma companies to produce recombinant proteins such as cytokines, growth factors, and enzymes for use in research, therapeutics, as well as diagnostics.

This article will focus on the benefits of partnering with a protein production service provider as well as how to select the best partner to ensure the successful production of your proteins.

Leading protein production providers tout a wide range of benefits including:

1. Quality and safety: Reputable GMP protein production services ensure that proteins are manufactured under precise guidelines, providing high levels of quality and safety

2. Customization: Services can usually be tailored to meet the needs of specific projects

3. Scalability: GMP protein production services can handle batches of varying sizes, many have the capacity to support mid-to-large scale production

4. End-to-end solutions: GMP protein production services often provide end-to-end solutions, including gene synthesis, protein expression, and purification, and they can work with template DNA, pre-optimized constructs, or stable cell lines provided by the customer

5. Regulatory compliance: GMP protein production services ensure compliance with regulatory requirements, including FDA submission, ISO 13485:2016, cGMP, and ISO 17025:2017 certifications, and cGMP-compliant environmental monitoring

6. Documentation and traceability: Comprehensive documentation, including lot-specific Certificates of Analysis, and traceability of production and quality control records are usually provided

7. Expertise: Partnering provides access to experienced teams with extensive knowledge in protein expression, purification, and analytical characterization, ensuring the highest quality proteins

8. Animal-free and animal component-free processes: Most vendors offer animal-free and animal component-free processes, ensuring that at no point in production are these products exposed to potential contamination by animal components or byproducts

9. Flexibility: Staff work with customers through every step from pre-clinical to GMP, offering flexible process development or tech-transfer of existing methods, custom assay development, and product-specific quality control analysis

10. State-of-the-art facilities: Services are typically provided in state-of-the-art facilities that support clients throughout the production process

Due diligence

Performing due diligence when selecting a protein production service provider is crucial for ensuring that the provider has the necessary expertise, quality control measures, and regulatory compliance to deliver high-quality proteins that meet the specific needs of your project. This process involves evaluating the provider's track record, technical capabilities, and risk management strategies. A thorough investigation can help make sure that you minimize the risk of errors, delays, and cost overruns, and ensure that you are partnering with a provider that can help you achieve your protein production goals in a timely and cost-effective manner.

The following considerations should be looked into as part of your due diligence in selecting a protein production service provider:

1. Quality control is of the utmost importance. Select a provider that is upfront about where and by whom your protein is generated.

2. While outsourcing protein expression services should result in cost savings compared to in-house operations, make sure to consider all costs, including those related to platform options, bulk costs for large quantities, and the ability to change your amount to meet growing demands at a lower cost.

3. Will you be able to tap into the skills and expertise of your partner to gain access to advanced reagents, technologies, and infrastructure. This can help ensure the viability of your projects and increase flexibility as your project progresses.

4. Research the provider's reputation, reliability, and experience in custom protein synthesis. Look for a provider with a proven track record of delivering high-quality, reproducible results.

5. Consider the provider's turnaround time and the level of support they offer. A provider with a quick turnaround time and responsive customer service can help streamline the entire process.

6. Look for a provider that offers customization and scalability in their services. This can help you meet the specific needs of your project, whether it's a small-scale custom batch or large-scale production.

7. Choose a provider with technical expertise in protein expression and purification. This can help ensure the success of your project and minimize the risk of errors or delays.

8. Ensure the provider complies with relevant regulations and quality standards. This can help minimize risks.

Finally, a first-rate protein production service provider will understand a wide array of projects to support its partners during all development stages. They also must possess the latest instrumentation and technology to facilitate the analysis of complex protein structures. Throughout the production process, all reporting and analysis must conform with safety and quality guidelines such as Good Manufacturing Practices and Good Laboratory Practices, while complying with and adhering to best-practice data integrity policies. This combination of expertise and credibility is essential toward generating trustworthy data for regulatory submission.