No matter where your pharmaceutical or biotechnology product development process lies, a quality contract laboratory is vital. Selecting the appropriate bioanalytical services partner requires carefully considering both current and future needs, such as method development, transfer, and full-scale production.
Selecting a lab that fits both your strategic and tactical outsourcing requirements can reduce workload and accelerate timelines, so here are some helpful hints when choosing one for your project:
Experience is of utmost importance in the bioanalytical services industry. As a drug developer, you need a partner with extensive experience handling new chemical entities (NCE) for various phases of clinical trials as well as advanced technologies like HPLC and LC-MS/MS to ensure accurate results. Due to its highly regulated environment, potential partners must demonstrate compliance with SOPs, GLP, and GDP.
Pharmaceutical and biotech companies increasingly rely on contract development and manufacturing organizations (CDMOs) to assist them with the complex task of finding their next medical breakthrough, so they must find a trusted partner capable of providing quality, consistency, reliability, efficiency and cost-effectiveness. Many sponsors take a tactical approach when outsourcing bioanalytical components of studies; such engagements often serve to manage peak workloads or expedite studies more rapidly than they could internally.
Utilizing a bioanalytical services provider allows you to take advantage of their capacity, experience, and quality of service to expedite clinical development programs faster. Furthermore, this relationship gives you flexibility, global reach, and expanded capabilities that may not be offered through a single CDMO.
One of the primary considerations when selecting a bioanalytical services partner is their ability to develop and validate methods that quantify drugs and their metabolites in complex biological matrices such as plasma, urine, and tissue samples. To do so successfully requires both an in-depth understanding of these samples’ structures and functions as well as employing sophisticated techniques like support liquid extraction, solid phase extraction or protein precipitation.
An expert bioanalytical services company will be able to offer you a range of assays that can be utilized across multiple clinical development phases to generate comprehensive pharmacokinetic profiles; these measures provide endpoints for drug exposure and metabolism within humans that provide vital data that allow you to determine therapeutic equivalence or safety of new therapeutic agents.
Bioanalytical services companies must keep pace with the pharmaceutical industry’s rapid changes, so bioanalytical services companies must invest in cutting-edge technology to develop assays that meet all current regulatory requirements. This may involve adopting advanced mass spectrometry techniques like ion mobility to increase the analytical capability of their instruments and deliver higher-quality data faster; also using lab automation solutions to decrease costs and maximize efficiency.
Bioanalytical laboratories can take advantage of advances in bioanalytics by aligning themselves with appropriate partners and tapping their expertise for guidance during development processes. A top bioanalytical services company should have both the scientific expertise and technical know-how necessary to incorporate new technologies quickly and precisely into assays and clinical trial samples while having enough flexibility to adapt methods when new regulations or guidelines come into effect.
Specialized bioanalytical services companies can also speed up development programs by offering insights into what regulatory agencies may need from labs, allowing the laboratory to quickly adjust practices and speed up turnaround time for sponsors.
Bioanalytical services companies must offer fair prices. They should provide an outline of the costs involved with any proposed study as well as explain what factors contributed to its cost; such as staffing levels, equipment needs and reagent purchases or running the laboratory itself.
Finalizing their services, a reliable bioanalytical services company should offer open dialogues with clients and be able to show that they can keep their promises. This may involve anything from quickly turning around an assay, handling special challenges of an individual project with ease or supporting both small-molecule and biologic development processes – to simply providing quick turn-around times on assays!
Choose a bioanalytical services company with all of the relevant certifications to help ensure its success. Consider selecting one with a quality management system and compliance with regulatory standards such as ISO 17025, GLP/GMP or FDA CFR 210/211. That way, your data will be reliable and results accurate.
Bioanalytical testing can be complex and time-consuming, so having a reliable partner is essential to the success of any project. Partnering with a bioanalytical services firm with the capabilities and technical insight to meet your needs will save both time and money – they should have enough capacity to take on all of your testing as well as be capable of creating assays for various conditions and disease states.
Bioanalytical services are experiencing tremendous global growth. This surge is driven by rising prevalence of infectious diseases and increased outsourcing services to research institutions and pharmaceutical companies. Government initiatives to control outbreaks of viral diseases like coronavirus have further fuelled demand for bioanalytical services.
Alera Labs provides bioanalytical services to clients across industries, such as pharmaceuticals, biotechnology, agrochemicals, medical devices, cosmetics, and chemicals. Services provided include assay development, pharmacokinetic and ADME studies, toxicological assessments, biomarker analysis, and method validation; HPLC/LC-MS/MS techniques are utilized by Alera Labs to analyze small molecular weight compounds as well as protein peptides nucleic acids microbial analysis samples.
QPS boasts lab locations in the United States, Netherlands, and Taiwan that can offer strategic solutions for companies conducting trials abroad or seeking to conduct bioanalytical work there. Our facilities can handle samples containing biosafety level 2 agents such as human immunodeficiency virus (HIV), Hepatitis A, B, and C viruses, influenza viruses and coronaviruses. Bioanalytical testing services offered by us include cellular assays and immunoassays, among others. Our scientists are committed to providing you with quality results for your projects – so reach out today and discover more about how bioanalytical testing can accelerate drug discovery!
Bioanalytical services market growth can be attributed to pharmaceutical companies outsourcing their research & development activities. Focusing on core strengths, reducing time-to-market, and improving cost-effectiveness are driving forces behind this trend; furthermore, the increasing popularity of biosimilars and small molecule drug candidates are expected to fuel further demand over time.
When selecting a contract laboratory to provide bioanalytical services, it’s essential to look beyond capacity and experience. Consider how the laboratory interacts with sponsors; is their turnaround timely, are any promises kept, etc. A carefully developed partnership between the sponsor and the contract laboratory can lead to long-term success even during trying times.
As part of an overall laboratory evaluation process, it is also critical to assess the quality and team dynamics within the laboratory. A highly capable and experienced team is essential in meeting client needs timely and efficiently while communicating efficiently enables effective collaboration and problem-solving.
Finding the ideal bioanalytical services company requires taking into account how their contract laboratory responds to challenges such as unanticipated delays or sample availability issues, which may have an impact on project timelines and results. This consideration should not be overlooked; as failure could have dire repercussions for project results.
As the pharmaceutical industry evolves, so will the need for advanced bioanalytical laboratories. As creating drugs, vaccines, and biosimilars requires sophisticated bioanalytical analysis involving complex biological samples – contract laboratories are now equipped to handle small molecular bioanalysis as well as electrophoresis tissue bioanalysis titrimetric assays immunoassays among others – making this industry transformation inevitable.
Partnering with us for your bioanalytical study can make all the difference to its success, so contact us now to see how we can assist. Our laboratories are capable of processing samples up to biosafety level 2 agents such as human immunodeficiency virus (HIV), Hepatitis A-B-C-E viruses and influenza strains as well as coronaviruses like SARS CoV-2 MERS CoV-2 and COVID-19; all available through our global network.
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