Implementing an Integrated Biologics Solution Can Improve Your Firm’s Process Efficiency
The biologics field has been dealing with pressures on multiple fronts lately. Sometimes they come in the form of potential regulatory changes that could affect patent protections. Other times, life sciences companies might face competition from rivals in the business of developing cheaper alternatives. In order to thrive in today’s crowded market, firms must take a hard look at their organizations and identify areas of improvement. Chances are, more often than not, the one area that could benefit from a boost is process efficiency.
The Benefits of Process Efficiency for Your Biologics Company
The external pressures mentioned above aren’t the only problems life sciences firms must contend with today. Many organizations must also deal with new price constraints, growing global competition, increased product complexity and more challenging therapeutic areas.1 Taken together, we would assume that keeping costs down would be the priority—and it should be. As the market tightens, companies will need to do all they can to maintain profit margins and protect their bottom line.
In reality, however, process efficiency goes hand in hand with keeping costs down. The old adage, “Time is money,” has never been more applicable than now. By ensuring that the different stages of the release cycle are efficient from start to finish, biologics firms can free up both human and instrumental resources. However, because the discovery and development phases often constitute the bulk of R&D costs, more focus is typically given to the manufacturing stages to keep costs down. The strategy is sound: a streamlined manufacturing facility that runs smoothly can offer resources to new products or provide extra capacity in the case of unexpected product demand.2 However, this doesn’t mean that the earlier stages should be ignored. In fact, biologics discovery and development can benefit from improving process efficiency as well.
Integrated Technologies Will Streamline Workflows Rather than Complicate
We currently live in age where we solve problems by adopting new technologies. After all, technology is meant to make our lives easier. Why wouldn’t we assume that it would do the same for the various stages of biologics R&D? Unfortunately, many organizations adopt technological solutions as separate pieces, without any thought as to how they work together. As a result, life sciences companies find themselves with disjointed software applications and disparate processes. For example, by having separate technologies for the respective discovery, development and manufacturing phases, we can end up with “walled-off” stages. Instead of a streamlined, harmonized workflow that supports continual improvement, decisions are made in isolation, without consideration of how they may affect other steps before or after.
Today’s organizations have devoted much energy into adopting solutions that allow them to identify potential problems earlier in the process. For example, a company may have software that lets them screen large numbers of potential drug candidates for optimal target suitability as well as developability in the earliest stages.3 But what happens next? Vast amounts of characterization data are obtained during the discovery phases. The problem, however, is that this information often remains in isolated databases, making it difficult to track project status in real time. To further compound the problem, these databases may store important pieces of information in incompatible file formats. In these cases, rather than making the process more efficient, disjointed applications may add time, forcing organizations to fall back on outdated solutions such as manual transfer. Along with inefficiency, such methods introduce the potential for human error into the equation. Given the fact that regulatory agencies are increasing their oversight of biopharmaceuticals, the prospect of adding error is one life sciences companies should avoid.
The ability to assess potential drug candidates in the earliest stages has other advantages. If key decision-makers can determine whether there’s a risk of downstream problems, such as potential manufacturing upscaling issues, the inverse is also true. They can pinpoint which candidates feature the best chance of binding to target activation sites. If an organization maintains an integrated, streamlined workflow, these promising compounds can be easily pushed down into the development pipeline without delay.
The BIOVIA Biologics Solution is an integrated solution for life sciences organizations that streamlines workflow. It supports their efforts to remain competitive in a crowded market in spite of challenges posed by the global economy, scientific complexity, and regulatory agencies. It provides tools that process high volumes of data related to cell lines or antibody candidates and can analyze sequence and activity information together. Most of all, the solution offers collaborative tools that boost process efficiency by allowing scientists to share crucial data models with registration, assay management, and compliance systems. Please contact us today to learn more.
- “Operational Excellent: More Than Just Process Improvement,” October 1, 2013, http://www.biopharminternational.com/operational-excellence-more-just-process-improvement ↩
- “Upstream Efficiencies, Economic Forces, and Changing Technologies Complicate Separation and Purification,” October 16, 2014, http://www.bioprocessintl.com/downstream-processing/separation-purification/upstream-efficiencies-economic-forces-changing-technologies-complicate-separation-purification/ ↩
- “Drug Discovery and Biotechnology Trends: Recent Developments in Drug Discovery: Improvements in Efficiency,” February 7, 2014, http://www.sciencemag.org/site/products/ddbt_0207_Final.xhtml ↩