Chemical characterization is an integral part of the life sciences industry. It factors into all aspects of pharmaceutical and medical device development, from preclinical research and early risk analysis to post-marketing surveillance of end products. The approach varies, though the methodology largely remains the same. Specialist workflows are used to identify and quantify the chemical constituents of a material or product to assess viability, analyze risks, determine efficacy and safety, support regulatory approvals, and more. This complexity can be challenging to manage, particularly for companies attempting in-house chemical characterization. Here, we will explore some of the pain points associated with in-house testing and suggest solutions based on outsourcing chemical characterization laboratory services.

Pain Points

1. Lack of In-House Expertise

Chemical characterization requires specialized knowledge and experience. Many companies, especially those with limited R&D budgets, lack the personnel with the necessary expertise. This can lead to inaccurate results, non-compliance, and potential safety issues. Without a team of experienced scientists and technicians, conducting thorough chemical analysis and interpreting complex data is challenging.

Outsourcing chemical characterization provides access to teams of experienced scientists and technicians. These professionals specialize in various analytical techniques and have extensive experience with complex materials.  Jordi Labs, an RQM+ company, has over 40 years of experience in polymer systems and is highly regarded for our extractables and leachables (E&L) testing. Our expertise ensures accurate and reliable results, minimizing risks and enhancing product safety.

2. Equipment Costs

The analytical equipment required for chemical characterization is expensive. High-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), and other advanced instruments represent significant capital investments. For companies with limited budgets, acquiring and maintaining such equipment is often impractical, leading to reliance on outdated or inadequate tools that compromise the quality of analysis.

Service providers invest in the latest analytical equipment, ensuring high-quality results and a broad range of testing capabilities. We utilize proprietary, multi-detector approaches and maintain an extensive database for better identification and quantitation. Our advanced tools and methodologies eliminate unknowns and reduce response factor variation, providing more accurate and comprehensive analysis than typically possible in-house.

3. Time Constraints

Conducting in-house chemical characterization can be time-consuming. The process demands meticulous sample preparation, analysis, and data interpretation. For companies juggling multiple projects, dedicating time and resources to chemical characterization can detract from other critical business activities, delaying product development and time-to-market.

Outsourcing chemical characterization is often more cost-effective than maintaining an in-house lab. Companies can avoid the high costs of purchasing and maintaining advanced analytical equipment. Additionally, outsourcing frees up internal resources, allowing companies to focus on their core competencies and accelerate product development. We offer streamlined processes and dedicated resources, resulting in faster turnaround times and improved efficiency.

4. Regulatory Compliance

Regulatory requirements for chemical characterization are stringent and vary across regions. Ensuring compliance with standards set by bodies such as the FDA, ISO, and AAMI requires deep understanding and continuous monitoring of regulatory changes. Without proper expertise, companies risk non-compliance, which can lead to costly delays, fines, and potential product recalls.

Service providers are well-versed in regulatory requirements and ensure that testing complies with relevant standards. We lead in developing and improving standards as members of AAMI and ISO committees. We also offer extensive support for regulatory submissions, helping companies navigate pre-submission and submission issues with the FDA and other notified bodies.

Other Benefits of Outsourcing

1. Flexible Service Options

Outsourcing provides flexibility with customizable testing packages tailored to meet specific client needs. Whether for one-off projects or ongoing support, service providers can adapt to varying demands. We offer a comprehensive suite of services, from biological evaluation and toxicological risk assessments to material characterization and polymer analysis, catering to diverse industry requirements.

2. Faster Turnaround Times

With dedicated resources and streamlined processes, service providers can often deliver results more quickly than in-house labs. We leverage our expertise and advanced methodologies to provide timely and accurate results, reducing the time-to-market for new products and ensuring compliance with regulatory timelines.

Interested in Laboratory Services?

Outsourcing chemical characterization laboratory services offers numerous benefits, from access to specialized expertise and state-of-the-art equipment to cost savings and regulatory compliance. By addressing the pain points associated with in-house characterization, companies can enhance their product development processes, ensure safety and efficacy, and remain competitive in their respective industries. Partnering with a reputable service provider like us at Jordi Labs, an RQM+ company, can significantly improve the quality and efficiency of chemical characterization, driving innovation and success.

Read the blog 👉 "New FDA Dataset Marks a Transformative Leap for Chemical Characterization"

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