BioPharm

www.biopharminternational.com March 2018 BioPharm International eBook 31 Outsourcing Resources Analyzing Biologics for biologics. Recognizing this, out- sourcing partners have invested heavily in both expertise and tech- nology to analyze biologics within full compliance of all regulatory requirements. This concentration of scientific expertise and capital- intensive specialized technologies are making earlier and broader bio- logics-based testing more efficient at contract development and man- ufacturing organizations (CDMOs) than it has been previously. Many of these companies now have the technical capability and capacity to bring some analytical testing for- ward in the development timeframe and to progress biologic candidates into clinical testing very rapidly. Kapetan (Eurofins): There are many benefits of outsourcing that our cus- tomers recognize. On a more basic level, outsourcing analytical services can provide temporary relief if the customer's in-house [quality control] QC lab is experiencing high back- logs due to fluctuating workloads. In these cases, it can be very conve- nient to have a trusted laboratory to outsource overflow work to in order to decrease the volume for the in- house lab, thus facilitating the abil- ity to meet tight turnaround times. On a more strategic level, having a long-term outsourcing partnership can not only minimize overhead costs (i.e., staff, capital expenditures for specialized equipment, etc.) but the right testing partner can also provide access to scientists with expertise in various areas for tar- gete d met ho dolog y a nd ma n- agement of high priority projects that cannot otherwise be handled in-house. Outsourcing analytical services can also help to eliminate conflict of interest by separating the QC testing from the in-house manu- facturing operation. BioPharm: Which analytical ser- vices are requested most often by bio/pharmaceutical companies? Pan and Merges (Catalent): Our biologics partners are often look- ing for full turnkey analytical solu- tions to assist with the development of their new molecules. The most requested niche capability is bioas- say development. In the small-mol- ecule area, the pharma outsourcing model has changed in recent years. Traditionally, big pharma only out- sourced late-phase and routine programs to analytical testing labs and retained early-phase method development projects and problem- solving activities in-house. Recently, however, we have noticed that our partners are transitioning many of their bench scientists from lab work to direct management of outsourc- ing activities and are outsourcing their analytical work at much earlier phases of product development. CHALLENGES IN BIOLOGICS BioPharm: What challenges in ana- lytical testing have developed in recent years? How can companies address these challenges? Kapetan (Eurofins): The biggest challenge in recent years has been ensuring compliance with the most up-to-date regulations specific to data integrity. This has required that companies perform gap analysis for each individual software system, including but not limited to: audit trail management, data backup, sys- tem security (i.e., passwords, access rights, etc.), and incident report- ing and change management. The gap analysis is intended to identify remediation activities required for each individual software system, and then those remediation activi- ties will need to utilize the industry standard ALCOA [attributable, leg- ible, contemporaneous, original or true copy, accurate] principles identi- fied in recent MHRA [UK Medicines and Healthcare products Regulatory Agency] and FDA guidances around data integrity. This process has been and continues to be time consuming and will require significant resource investment throughout the industry. Pan and Merges (Catalent): There are a few challenges that come to mind. The first two are the veloc- ity at which technology is evolv- ing and the increased volume of data being generated. Technical advances by instrumentation ven- dors and follow-on capital invest- ments have allowed Catalent to reduce a na ly t ica l test i ng t ur n- around time in many cases whilst prov iding more extensive data packages. The additional challenge is in training and retaining quali- fied scientists. Catalent places a lot of emphasis on scientific training, collaborative problem solving with partners, and continuous education, including through participation in conferences and trade shows. BioPharm: How has the surge in biologics development affected the analytical services you provide? Kapetan (Eurofins): The surge in biologics development has led to an increased demand for rapid test- ing methods, as well as the setup of automation systems, in order to meet tight turnaround times and cost-effectiveness in biopharmaceu- tical analytical testing. The rapid testing comprises impurity test- ing methods, such as sterility and mycoplasma testing, as well as ELISA [enzyme-linked immunosorbent assay] and cell-based bioassays by qualified automated systems. Off- the-shelf methods and platforms are available and can be adapted to the requirement of each biopharmaceu- tical molecule. Pan and Merges (Catalent): Pharma companies have tried shifting their own key internal resources from small molecule to biologics programs, but the skill sets required for per- forming niche biologics analytical services such as bioassays are scarce. Using bioassay as a further example,

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