While there are fundamental differences between pharma and biopharma, there exist many commonalities also. One of them being the vital importance of analytical testing.
As with small molecule drugs, chemical analysis is used to:
- control quality
- increase productivity
- optimize processes
- characterize compounds – in this case, biosimilars and biologics.
Biopharmaceutical Analytical Testing & Quality
For drug manufacturers, quality is an ever-present concern. Robust quality management is necessary to avoid problems – including capacity bottlenecks and product failures. Further reinforcing the importance of quality assurance, today’s regulatory environment emphasizes extensive product study to confirm quality optimization.
Biopharmaceutical analytical testing is an essential component of quality management. It includes the detection, separation, determination and purification of specific biopharma compounds. Without accurate analysis, quality issues are much more likely to occur.
Biopharma analytical testing mirrors small molecule analysis in many ways. For example, raw materials must be tested to confirm they contain the required components in the proper quantities. Additionally, the materials may be checked for contaminants that could alter product outcomes. Critically, testing must be performed in real-time, be well-planned and systematic to assure confidence in the analyzed substances.
Meeting the Demands of Process Analytical Technology (PAT)
According to the Food and Drug Administration (FDA), Process Analytical Technology (PAT) is defined as:
“A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.”
Since PAT’s launch by the FDA in 2001, the regulatory framework has been vital to the development and scale-up of processes required to synthesize biological active pharmaceutical ingredients (APIs). PAT offers an effective method of reaction-path monitoring, which leads to a more thorough understanding of process parameters. Ultimately, this results in more efficient and safer methods of synthesis.
Pharmaceutical Guidelines notes that the PAT system supports the FDA’s belief that “quality is not a question of testing but one of designing. Quality is designed into products, not tested into them.”
The FDA highlights two of PAT’s innovation-backing elements:
- Science-based tools and principles that encourage innovation.
- Strategic regulations that support bio/pharmaceutical innovation as a strategy for regulatory implementation that will accommodate new ideas, products, and methods.
The premise of PAT is not just batch-testing; instead, the principle opens the door for innovative approaches to the development, testing, and control of pharmaceutical products.
The FDA contends that:
“Pharmaceuticals continue to have an increasingly prominent role in health care. Therefore, pharmaceutical manufacturing will need to employ innovation, cutting edge scientific and engineering knowledge, along with the best principles of quality management to respond to the challenges of new discoveries (e.g., novel drugs and nanotechnology) and ways of doing business (e.g., individualized therapy, genetically tailored treatment).”
It is well understood that biopharmaceuticals are more complex than typical small molecule drugs. Drugmakers, often by necessity due to limited internal resources, focus attention on the key tasks needed to move products from the bench to the pharmacy shelf. This may sometimes come at the cost of forsaking secondary or tertiary activities which are nonetheless critical to success, such as analytical testing. To meet the demands of PAT, outsourcing your testing may be the best option.
Why Outsource Biopharmaceutical Testing?
Proper testing—although necessary—can consume enormous quantities of time, financial resources, and manpower. The staff assigned to the analyses must have expert knowledge and the time (and other resources) to complete the testing.
Many drugmakers – especially virtual-, small-, and mid-sized companies – lack these resources. Generally, this challenge has been magnified in the biopharma space, in which biomolecules are significantly more complex than their pharma small molecule counterparts. By using a trusted external provider to perform repetitive testing (and other, more complex, analytical or process development tasks), drug developers can focus attention on other organizational priorities.
Here are a few reasons why biopharma companies leverage outsourced analytical testing:
- Trusted expertise. It isn’t enough to build and launch an analytical testing department, it must also be staffed with experienced personnel. With outsourcing, companies have ready-made access to experienced analytical staff and facilities with proven track records – often with biomolecules similar to a company’s candidate.
- Cost. Outsourcing can help companies save money by decreasing spending and infrastructure investment. This is often the case with running and maintaining expensive analytical instrumentation which analytical methods may require – not to mention the cost of hiring, training and maintaining analytical staff and specialized testing facilities. These expenses can be managed (or better directed to other drug development efforts) through outsourcing testing.
- Lasting partnerships. Drug companies often need partnerships to accomplish their ultimate goals. Building relationships with external organizations allows drug companies to develop a go-to network of resources as additional testing needs arise across the drug’s lifecycle.
- Focus on core competencies. Companies can shift their focus back to core competencies which directly impact organizational success by outsourcing pharmaceutical testing.
- Increased competitiveness. In many cases, small pharmaceutical companies compete directly with larger organizations. However, the expense of testing facilities and qualified staff, along with regulatory filings & approval, can be exorbitant. Outsourcing pharmaceutical analyses grants smaller drug companies access to the human resources and expertise of a more experienced testing organization.
For many bio/pharmaceutical industry firms, today’s analytical testing needs have made the flexibility and efficiency of outsourcing indispensable.
Learn more about LGM Pharma’s standalone analytical testing services for drugmakers.