How Bioanalytical Services Benefit Drug Development

Bioanalysis is a key aspect of drug development, often being one of the first R&D activities outsourced by pharmaceutical companies.

When selecting a contract laboratory for bio analytical services, look for laboratories with strong science capabilities, efficient processes and information technology systems, excellent regulatory compliance, quick turnaround times from sample receipt to report delivery, as well as an impressive portfolio of assays.

Cost-effectiveness

The global bioanalytical services market is expanding quickly, drawing in both newcomers to the industry as well as increasing competition among long-established CROs. New entrants to the field and long-established CROs alike are offering increased service capabilities and assay options to their customers, yet due to increasing costs associated with creating these assays some bioanalytical services are experiencing price hikes.

Pharmaceutical companies use bioanalytical outsourcing as a cost-cutting and efficiency strategy during drug development, and to focus on their core R&D function of bringing drugs to market and expanding product portfolio. Contract laboratories may reduce capital investments while eliminating staff expenses altogether.

Bioanalytical testing is an integral component of preclinical and clinical investigations of therapeutic molecules or their metabolites, including bioavailability/bioequivalence evaluations or nonclinical pharmacokinetic and toxicokinetic studies that require concentration data collection. Ultimately, the outcomes from such analyses help determine if therapeutics can be approved for commercial sale.

As part of any clinical trial, it’s essential to monitor the quality and consistency of bioanalytical data. Any discrepancies could result in delays or costly revisions of its final report; this can especially prove costly when working with small-molecule drugs that must adhere to stringent regulatory standards.

As it relates to bioanalytical testing, it’s vital that clinical research organizations (CROs) possessing full understanding of its full scope can deliver accurate, timely and consistent results. Furthermore, CROs should possess knowledge of FDA bioanalytical method validation guidelines as well as expectations from global regulators; this will ensure their assays meet regulatory review at every phase of a clinical trial.

Large organizations usually outsource bioanalytical services through a multidisciplinary team comprised of project manager, bioanalytical scientist and quality assurance representative. Smaller businesses may assign a single individual the task of selecting their contract laboratory provider – generally selecting according to capabilities, location and compatibility with other services offered by their organization.

Flexibility

As part of any drug development effort, fast, accurate and precise analytical methods must be utilized during every stage. Outsourcing bioanalytical testing to an organization with adequate expertise and equipment could prove crucial; without them, clinical trial data or the project itself could become jeopardized.

Bioanalytical services play an integral role in drug development, supporting nonclinical and clinical assessments such as toxicokinetics and pharmacokinetics assessments, bioavailability analyses, drug-drug interactions tests and other systematic evaluations. As a result, much of the work associated with pharmaceutical product development is outsourced to third-party laboratories.

Contract pricing models vary based on the nature of work being completed. Method development fees may include hourly charges based on estimates of time it will take to develop an assay that meets scientifically robust standards, while production bioanalytical testing typically offers flat rates per sample with variable fees depending on volume. No matter which contract pricing model is selected, it is vital that an outsourcer be highly experienced in your therapeutic area.

Bioanalytical laboratories must also have the capacity to quickly turn around projects. A quality contract research organization will be able to quickly design, validate and execute an assay tailored to your compound within weeks or days of receiving initial inquiries, giving you confidence when conducting preclinical PK / TK and DDI studies – giving the information needed for go/no-go decisions in a timely fashion.

Bioanalytical laboratories must also be equipped to handle large capacity needs over long periods, which is especially crucial when assessing vaccine efficacy and other immunogenic compounds. NJ Bio’s facilities in Exton, PA and Hayward, CA offer GLP-compliant quantitative mass spectrometry services at all stages of drug development for vaccine evaluation purposes – our LC/MS scientists perform ADME screening, human clearance predictions, protein binding assays and drug-drug interaction tests among others.

Bioanalytical services markets have experienced rapid expansion, drawing in numerous newcomers into the industry and providing much-needed competition between service providers – leading to more efficient operations with improved services at more reasonable costs.

Speed

As developing drugs requires significant investment of both time and money, pharmaceutical and biotech companies require support from an experienced bioanalytical lab in order to ensure their projects are successful. Specialist laboratories can develop methods, execute assays on compressed timelines and offer regulatory insights – helping reduce overall development costs and expedite the process.

No matter if you are testing antibodies, peptides, or small molecule drugs; accurate results with fast turnaround times are required for successful outcomes. Specialized labs employ high-performance liquid chromatography (HPLC) and LC-MS/MS techniques in their work to provide quality, reliable, and consistent results that can be applied across various applications such as formulation optimization, bioequivalence studies, quality control or quality management.

The global bioanalytical services market is expanding at an astonishingly fast rate, driven by rising pharmaceutical sales and research activities in the pharmaceutical sector. The market can be divided into several segments based on application, product provider and region – Oncology being the largest segment due to increased clinical trials as well as worldwide prevalence.

Bioanalytical services are an integral part of drug discovery from nonclinical to clinical stages. Without these services, understanding how a drug functions within the body and creating a comprehensive regulatory submission will not be possible – hence why big pharma often collaborates with specialized labs in order to develop, test and validate bioanalytical methods.

CROs and sponsors face several difficulties when working with bioanalytical laboratories, according to a survey conducted by Bioanalysis Zone. Some of the most frequent obstacles include unresponsiveness, lack of technical/scientific expertise and unmet timelines; these issues can be overcome through better communication, an agreement on expectations prior to starting projects and shared training programs. Furthermore, don’t compromise quality in order to save both time and money; challenge your labs instead to provide reasonable prices with good value!

Expertise

With drug development being such a complex endeavor, even top pharmaceutical companies requiring expert assistance need expert support in order to meet deadlines and regulatory expectations. Bioanalytical services company play a pivotal role in fulfilling CMC requirements for pharmaceutical and biotechnology companies seeking to bring therapeutic products to market quickly.

No matter if it’s clinical or preclinical PK/TK, ADA, NAb, protein binding or biomarker studies, having the right partner can make all the difference in project success. Working with an appropriate contract lab will reduce risks while speeding timelines while still giving your drug developer flexibility as your product evolves through development.

Consider their breadth and depth of expertise when selecting a CRO. A full-service CRO should offer support for all bioanalytical needs such as sample handling and QC; comprehensive assays should also be available throughout your clinical program; an experienced research team should work closely with both you and regulatory teams to ensure accurate results from assays performed by them.

As well, working with a CRO with experience developing sensitive and robust mass spectrometric methods can streamline preclinical and clinical studies significantly. Doing this saves both time and money because assay development doesn’t have to take place internally. Furthermore, having access to experts who conduct PK/TK and ADA studies across biological fluid types enables further time savings by using one test for multiple studies.

The global CRO market is experiencing rapid expansion due to the increasing need for lifesaving drugs to treat life-threatening illnesses and diseases. Cancer cases reached 19.3 million cases worldwide in 2020 – liver, breast, lung colorectal and prostate are among the most prevalent cancer types affecting patients worldwide. With so many people needing treatment for cancer-targeting drugs being developed by pharmaceutical firms; concurrent with biosimilar growth and continuous processing fueling more rapid, sensitive and accurate bioanalytical tests for diagnosis purposes.