Eurofins Lancaster Laboratories can mitigate risk and reduce regulatory scrutiny of biologics raw materials
by Andrew D. Schaefer, Principal Scientist/Group Leader; Terry Schuck, Manager, Bio/Pharmaceutical Biologics Raw Materials
The emergence and significant clinical success of cell-based therapies, and the multifaceted clinical utility of targeted antibodies, have led the pharmaceutical industry to shift an increasing share of their focus toward the biologics market. As new therapies begin to receive agency approval, there is a need to ensure product efficacy, process efficiency, and cost effectiveness. The high manufacturing costs of the requisite bioprocesses, and an ever changing regulatory landscape, have created new challenges in managing biologics raw materials.
Ensuring product efficacy with process efficiency requires significant forethought and planning. The economies of scale benefits associated with conventional small molecule manufacturing are not applicable. As a result, an obvious conclusion is to maximize efficiency by using manufactured pre-packaged reagents. This has led to an ever-growing consumption of proprietary media and sera, recombinant enzymes and trademarked resins needed as raw materials for various bioprocesses and purifications. Due to proprietary restrictions, the manufacturers of such reagents may only provide redacted information about the composition of many of these complex mixtures. As these therapies move towards Phase 3 testing and marketed release, the compliance risk associated with accepting a manufacturer’s Certificate of Analysis for quality release may no longer be a relevant option.
With no established test procedures and very little compendia based guidance, there is an obligation to establish suitable test methods for QC release of these materials. Since the information about the base composition of the proprietary formulation is often unknown to the user, test methods must be developed to gain a better understanding of the attributes of the materials used in processes and establish quality controls around those attributes.
Eurofins Lancaster Laboratories is well versed in evaluating the identity, purity, potency and quality of a diverse range of materials used in a wide array of bioprocesses. Platform methods can be used to quickly establish a suite of quality control tests in any phase of production, in a cost effective manner. Custom assays and residual methods can be developed to pinpoint critical material attributes that require monitoring. This combination of rapid turnaround platform QC tests with robust custom methods enables clients to promptly meet or preempt regulatory agency scrutiny.
Our 20 years of biochemistry experience, dedicated teams of scientists, and state-of-the art instrumentation heighten our comprehensive lab capacity to proficiently advance projects of any size, phase, or complexity. Using established GMP platform methods, as well as customized methods developed to fit unique client needs, compliance and business risk can be mitigated. Eurofins Lancaster Laboratories understands the needs of the industry and is prepared and equipped to meet those needs.