Focused on your needs, our specialists provide exceptional precision bioanalytical services, and comprehensive research support for a wide range of study types — working with you to accelerate development, meet your milestones, and ensure compliant, on-time regulatory submissions for your drug candidates.
We offer a full range of bioanalytical services conducted in state-of-the-art, purpose-built laboratories at our locations in the U.S. and Canada, with designated containment Level 2 areas for work with Risk Group 2 pathogens. Staffed by highly-skilled analysts, and shifts running 24/7 (as needed), our bioanalytical services can process over 60,000 study samples per month. Precision bioanalytical services are available as stand-alone, or part of a package of services.
For additional information on our Bioanalysis Solutions, consult our Fact Sheets:
Our bioanalytical services subject matter experts are responsive and flexible throughout all stages of your drug development pathway. Our unique array of platforms and large list of validated assays ensures the most effective methods for your individual programs.
- 100+ highly trained regulatory bioanalysis specialists
- 25+ research and development scientists
- Capacity to accommodate 60K+ study samples per month
Our preclinical and clinical laboratory space in both the U.S. and Canada includes designated containment Level 2 (CL2) areas for work with Risk Group 2 (RG2) pathogens. Because of our work with NHPs, our preclinical site has BSL2 designation for various species. Our bioanalytical services analysts are available 24/7 depending on your program needs, to ensure that we process your samples within agreed-upon timelines.
Our team of dedicated bioanalytical scientists works with the latest equipment to provide bioanalytical services from discovery to preclinical and clinical pharmacology, in accordance with GLP and current FDA/EMA guidelines for both small and large molecules, including immunogenicity and biomarkers. Each bioanalytical validation and bioanalytical phase for sample analysis has an assigned Bioanalytical Principal Investigator.
We have experience with a wide spectrum of biological matrices in both animal species and humans, including serum, plasma, blood, urine, feces, tissues, cerebrospinal fluid, and vitreous humor. Our capabilities include supporting microsampling (Mitra® VAMS®) and dried blood spots for preclinical and clinical programs.
Assigned bioanalytical services study personnel maintain open and constant communication with key stakeholders through regular conference calls and data sharing, adjusting, and managing the project progression as needed.
SMALL MOLECULE BIOANALYTICAL SERVICES
Our over 20 years of experience with small molecules has provided an extensive in-house database of over 680 assays, with more being added all the time. We have delivered customized, unique solutions in derivatization, chiral separation, drug stabilization, and labile and multiple metabolite quantitation, using state-of-the-art instrumentation and protocols to achieve low quantitation limits with limited sample volume. Some small non-biological complex drugs (NBCD) such as iron sucrose are more suitable for our Ligand Binding platforms.
LARGE MOLECULE BIOANALYTICAL SERVICES
We are renowned for our vast experience in LC-MS/MS and Ligand Binding bioanalytical platforms. We evaluate each request and provide customized workflows to allow accurate quantitation using appropriate platforms (mass spectrometry and/or ligand binding). Our experienced and dedicated research and development scientists develop validation-ready assays, customized to your needs, using advanced instrumentation.
The quality of bioanalytical services and methods is an integral part of ensuring the success of gene therapy medicinal products (GTMPs). Robust bioanalytical methods for quantification of DNA or RNA transgene, the vector, as well as the expressed gene moieties and assessment of their immunogenicity are critical elements in the understanding of pharmacokinetics (PK), pharmacodynamics (PD), and safety/toxicity.
How we Support your Program
Our bioanalytical Principal Scientists have over 20 years of industry experience. We collaborate with your team and offer guidance on:
- Necessary steps to advance your GTMP program
- Appropriate technology to utilize in the analysis of your GTMP
- Subcontracting the generation of critical reagents, such as positive control for assays
From initial animal studies to human bioanalysis, Altasciences’ experts are available to partner with you, and share their knowledge in the sensitivities and changing landscape of gene therapy development.
- Study design and work scope planning
- Nucleic acid purification from blood or tissues
- Protein extraction
- qPCR, RT-qPCR, ddPCR
- mRNA and protein expression
- Flow cytometry
- PK assays
- Multiple matrices and tissues
- Method transfer or full method development
- Qualification or fit-for-purpose validation
Altasciences has invested in scientific experts and state-of-the-art instrumentation to provide gene therapy-related services that address sponsor needs through every phase of development. Our scientists leverage our vast experience with polymerase chain reaction (PCR), flow cytometry, and all related genetic therapy services, such as NAb assays, common adeno-associated viruses (AAVs), and Lentivirus, to support GTMP development programs.
Our bioanalytical team has extensive experience with analysis across viral vectors. We test for neutralizing activity against the gene therapy vector, as well as against the gene insert.
Our laboratories are designed to deliver a full gene therapy program, from analysis of the virus, biodistribution, quantification of the mRNA expression, and finally bioanalysis of the expressed protein.
Our PCR laboratory provides space and time separation of pre- and post-PCR activities, with equipment in distinct, pressure-controlled rooms. We follow strict anti-contamination protocols, and control for external factors regarding clothing, equipment, environmental and reagent sterilization, etc., to deliver clean and reliable data.
Our teams use the latest equipment, including Biotek readers, flow cytometry, MSD, CFX96™ real-time PCR detection systems, QX200™ droplet reader and automated droplet generator, LC/MS, and other instrumentation to conduct gene detection, gene analysis, genetic variation analysis, and array data validation.
Our bioanalytical services teams are experts in working with biomarkers that aid in the translational of preclinical results to the clinic. Our bioanalytical scientists collaborate with our toxicologists and clinical pharmacologists to select the most suitable biomarkers that will provide fit-for-purpose results.
Research Support Services
Our comprehensive full-service ancillary offering complements preclinical and clinical services to best meet your needs. We are committed to providing accurate, rapid, and reliable results.
We can help you navigate the program development landscape and prepare a study design that best accommodates your specifications and goals, while meeting the requirements of corresponding authorities. Our preclinical and clinical staff works in close collaboration to define your program needs and ensure successful transitions between preclinical and clinical.
We work with you to translate your clinical study design into the protocols and technical execution that drive effective study conduct.
High quality project management is key to the success of your preclinical and clinical trials. Our project management team has extensive expertise in a wide range of study types and therapeutic areas.
We deliver comprehensive data management services using efficient and meticulous processes, coupled with state-of-the-art technologies to ensure your clinical trial data is managed with precision and accuracy.
Our biostatisticians and statistical programmers work in synergy with internal colleagues and departments to provide you with timely, high quality statistical services, in accordance with regulatory requirements.
As part of our preclinical offering, we perform comprehensive formulation and analytical services, and have the expertise to ensure your method development is compliant and reproducible. We provide a full range of analytical support ranging from characterized assays to meet pre-GLP lead optimization needs, to feasibility, method development, method transfer, method validation, and sample analysis for both preclinical and clinical phases of development. We understand the importance of properly evaluating your test article and are here to provide you with key analytical support to drive your small or large molecule forward.
Our scientists have extensive experience determining the relationship between the toxicological effects and the exposure of a new therapeutic entity in rodent and non-rodent species. Whether your test article needs to be detected by chromatography or ELISA, our broad range of GLP analytical services offered in our laboratories complements our in vivo capabilities to provide the exact data that you need.
Our range of services includes histology, histopathology, light and electron microscopy, immunohistochemistry, immunofluorescent staining, and cell morphometry. Our professional teams include histologists, who perform comprehensive histology services compliant with good laboratory practice (GLP) regulations, and highly experienced board-certified pathologists to provide expert histopathologic tissue analyses, scientific reporting, and study consultation.
Our clinical pathology laboratory staff has extensive knowledge of animal hematology (protocol-driven, ~17 parameters available), coagulation, clinical chemistry (~40 parameters), and urinalysis (dozens of parameters available, depending on study protocol). Specialized pathology laboratory services, such as thromboelastography (TEG) are available to meet your program assay or biomarker development needs. We design the clinical pathology component of protocols to optimize the opportunity to achieve study objectives so that all data generated can be interpreted with confidence in the relevant species.
We offer state-of-the-art, GLP-compliant archiving solutions in a purpose-built, stand-alone facility that can archive both dry and wet tissue samples.
Our Archiving services include:
- Experienced and dedicated staff, including Lead Archivist
- Archive Management Database for tracking all materials and original hard copy records
- Secure transfer services for paperwork, specimen and cold storage samples
- Secure destruction for all materials onsite
- Duplicate CDs to maintain integrity of electronic data
- Annual verification of materials through a facility audit
We offer the following GLP-compliant archiving solutions within an HVAC-controlled environment:
|Material Storage Capabilities||Security Specifications||Facility Assets|
Altasciences has a team of highly experienced, well-trained CRAs to expertly oversee all the relevant aspects related to conduct of your study. Their individualized attention ensures compliance with your protocol and GCP as well as securing patient safety and data integrity. Our CRAs are dedicated to monitoring all the details of your study, from initiation to final close-out, including the following:
- Site selection and qualification according to established criteria and subject population
- Initiation of study centers to the study protocol and plan
- Performance of source document verification to ensure GCP, patient safety and data integrity
- Review of on-site regulatory documents to ensure compliance
- Review of the eCRF between visits
- Preparing timely, comprehensive correspondence and site visit reports
- Effectively working with sites to close-out the study, resolve outstanding queries, and return IP
We work with the study site to foster excellent performance through training, mentoring, and managing study personnel. Our clinical monitors oversee the progress of your study, ensuring strict adherence to protocol and regulations, safety of subjects and accuracy of visit reporting. Our monitoring plans can include standard on-site monitoring, central monitoring, risk-based monitoring, or a combination of approaches to meet your needs.