Buy vs Build: Bioanalytical lab
Buying a bioanalytical lab vs. building one yourself – what do you need to consider?
With so many outsourcing/insourcing options across the drug development workflow, Pharma companies are faced with finding the right partner to fit all the needs of their unique molecule. Here are some criteria to consider:
- Time to Launch: timelines depend on the approach. A built-for-purpose project translates to long timelines due to all the parties involved. You need time to evaluate location, engineers, & architects. Return on investment and risk impact: both are dependent on the number of programs and the diversity of projects. To fully evaluate, you need to build utilization models to analyze and make predictions
- Staffing appropriately: the job market can be challenging to navigate, and it could prove to be challenging to find the right expertise and employees. Be prepared for this process to take time and be costly.
- Day to Day Logistics: there are a wide variety of permits & licenses needed for day-to-day operations. This regulatory environment can be complicated to navigate as you manage the applications, requirements and maintenance required.
If you are interested in learning more about permits & licenses specifically, check out our fact sheet: Guidelines to Importing & Exporting Biological Samples - And much more…
Explore our comprehensive guide that outlines the benefits & risks associated with buying or building a bioanalytical lab and see what choice is best for you.
Guidelines: Importing & Exporting Biological Samples
The United States government has a heavily regulated process for importing and exporting biological samples, and for good reason. These protocols are designed to prevent the transportation of exotic diseases and to inhibit the supply to illegal markets.
While understanding the reasons for the high regulation, it can still be extremely complicated to navigate the different governing bodies and acquire the correct applications or permits. Failure to follow the process also has dire consequences: samples can get held at customs, there may be fines involved, and your estimated drug development timeline just got much longer.
We know how frustrating delays in your development process are. Our comprehensive guide gives you the information you need to be confident that your samples will not be compromised, and your timeline will not be delayed. Download our comprehensive guide to learn how to properly import and export biological samples to avoid potential issues and stay on track.
Personalized therapy selection: Investigation of multiple immune-checkpoints
PD1 blockade has changed the immunotherapy approach against solid tumors – prescribing patients’ monoclonal antibody-based therapy yielded positive results. However, the number of patients that benefited was small compared to expectations, and lack of attention paid to immunohistochemistry could be responsible. Understanding the tumor microenvironment with a single biomarker is not accurate enough to predict the interaction of the drug with the site of action, or to predict the effectiveness of the drug for the patient.
In this application note, industry expert, Corinne Ramos, PhD, discusses how understanding the tumor microenvironment (TME) at the biomarker level is not enough to predict the interaction of the drug with the site of action. Her study performs a deep spatial profiling of biomarkers on two baseline non-small cell lung cancer (NSCLC) tissue samples. The population of gene expression was characterized with a focus on a specific region of interest on the tissue where she could draw conclusions on the TME.
Her research walks through:
- Immune infiltration
- How phenotype correlates with ICI response
- T-cell-inflamed gene-expression profiles
- Immune suppressive pathways that reduce ICI activity
- Tight immune checkpoint targeting.
Learn why the TME needs to be investigated at the molecular level to accurately prescribe the appropriate therapy.
Top 8 Benefits of Mass Spectrometry Imaging Early in Drug Development
Mass spectrometry imaging (MSI) is a groundbreaking technology that provides visuals of complex biological samples to study a drug’s distribution and understand its potential toxicity. MSI can unlock crucial data and give scientists additional insights into drug discovery, diseases, and personalized medicine.
MSI is beneficial in early development and murine models across many therapeutic areas and is especially suited to oncology due to the availability of tissue. With MSI you can:
- Speed up and optimize the drug discovery process
- Visualize drug distribution in tissues and tissue sub-compartments
- Analyze samples for thousands of compounds at once
- Eliminate sensitivity and chemical alteration concerns
- Know whether efficacy is possible based on distribution
- Locate and identify metabolites to understand potential toxicity
- Improve understanding of pharmacokinetics and pharmacodynamics
- Save money and provide a competitive development edge
Download our infographic to learn more about the benefits of mass spectrometry imaging in oncology.
BIOANALYSIS: Approaches and Techniques for Small vs. Large Molecules
Bioanalysis plays a crucial role in the evaluation of potential drug candidates and in understanding the drug’s pharmacokinetics and pharmacodynamic profile during early clinical trials. By documenting a drug’s behavior within the body, our specialists generate essential data that regulatory authorities rely on to determine whether the drug is safe for market release.
Before choosing a suitable testing technique, it’s important to understand three factors, type of molecule, unique properties of the drug, and its intended application. Regardless of the molecule size, it’s crucial to validate appropriate methods capable of measuring the drug’s concentration and bioactivity over time.
Download our infographic to learn more.
Importing and exporting biological samples: Dos and don’ts
To ensure that your drug program’s timeline stays on track, it is crucial to follow the strict guidelines for importing and exporting biological samples. Too often, there are several mistakes with execution that could have been avoided with proper planning, coordination, and communication. These errors not only lead to frustration but also can result in:
- Costly delays
- Project rework
- Logistic challenges
- Lost, delayed, or damaged samples
- Handling mishaps
Discover the 5 best practices and mistakes to avoid when navigating the import and export of biological samples.
Build a bioanalytical strategy that will ensure speed and agility
In order to build a robust bioanalytical strategy for your drug discovery program, it’s crucial to collaborate with a partner who possesses both industry expertise and a track record of operational success.
Aliri by the numbers:
- 48-hour turnarounds in discover
- 150 biological fluids & tissues
- 1 million samples analyzed
Our team of seasoned scientists, industry experts, program managers, and quality specialists can help you develop a successful bioanalytical strategy that will maximize the growth of your drug discovery investments. Work with us to gain access to a robust suite of mass spectrometry platforms, achieve quality data to quickly file your IND, NDA and CTA, and forecast potential roadblocks that may cause delays in your project’s timeline.
Download our factsheet to explore our offerings, platforms, compounds, regulations and more.
The Future of Small and Large Molecule Bioanalytics—Today
In bioanalysis, the future of small and large molecules offers exciting prospects for advancements in drug discovery, diagnostics, and therapeutics. With the increase of larger substances, emerging technologies, and new analytical approaches, drug developers are faced with both new opportunities to evaluate complex substances, and new challenges to address. Therefore, it’s important to learn which bioanalysis techniques are right for your drug.
In this white paper, you’ll learn about:
- Bioanalysis by molecular size
- Advancements in mass spectrometry
- Visualization and quantification of drug distribution
- The era of spatial imaging
- Novel technologies and adaptions
For more information about emerging technologies revolutionizing the field of bioanalysis, download our whitepaper today.
Common Approaches to Bioanalysis of Oligonucleotides
The significance of oligonucleotides (OGNTs) in drug development is increasing rapidly, as they offer promising and life-changing treatments that can improve patients’ lives. However, the promising and vast opportunities of OGNTs come with a unique set of challenges and nuances unlike other types of molecules.
Within bioanalysis, there are 5 main approaches for OGNTs to consider:
- LC/UV
- LC/MS/MS
- Hybridization LF/FD
- LC/HRMS
- Hybridization ELISA
Learn how to evaluate the pros and cons of each approach to decide what’s best for your OGNTs.
Validating the efficacy of a compound with spatial imaging
With the ever-changing drug development landscape, pharma and biotech companies have the challenging task to quickly and efficiently generate quality and unique data to file an IND. Spatial bioanalysis is a unique solution that can help you achieve this goal, while also enabling strategic and optimized decision making throughout your process.
Download this spatial bioanalysis white paper to gain insights from industry expert, Corinne Ramos, PhD. Discussion points include:
- Precision medicine development and added value
- Disease heterogeneity: Why is it? Why is it important? How do we visualize it?
Target discovery and development of composite biomarkers