Safety Assessment
In contrast to most chemical drugs, biologics are complex compounds made from living cells with highly complex structures that are not easily characterized or replicated. As a result, small differences can have unexpected or harmful clinical outcomes for patients. Toxicity can occur if the drug is administered too rapidly or in too high a concentration or amount. The purpose of safety assessment in preclinical studies is to determine the safe amounts and timing for our agents and to ensure that for adults and even newborns or pregnant women, the probability of an adverse event resulting from a biologic drug is reduced. Along with our biologics development and manufacturing services, BOC Sciences offers a comprehensive range of biosafety testing services. We have built a reputation for our biosafety services by maintaining an excellent record of execution and compliance. At BOC Sciences, our highly trained scientists work with an efficient project management team to provide unprecedented safety assessment services to our clients.
Figure 1. The author presents an augmented safety triangle that can help ensure a holistic and integrated approach to product safety. (Plavsic, M. 2016)
Our Services
To make it easier and better for researchers, BOC Sciences provides safety assessment service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs.
General Toxicology
We perform general toxicology studies to support pharmaceutical development programs:
- Study types
Acute/single dose
Sub chronic
Chronic
- Routes of administration
Oral (Gavage/intubation, tablet/capsule, dietary)
Parenteral (IV injection/infusion, intramuscular, intraperitoneal, subcutaneious, intradermal)
Topical (dermal, ocular)
Other routes (Intravenal, intranasal, intravesicular, vaginal, rectal, brain implantation)
Safety Pharmacology
Our team offers the following types of safety pharmacology studies in both large and small animal species:
- Cardiovascular system
- Respiratory system
- Supplemental safety pharmacology studies
- Special safety studies
- Ion channels
- Medical device safety evaluation
- Natural product safety evaluation
- Pharmacology efficacy studies in multiple animal species
Immunology and Immunotoxicity
BOC Sciences’ preclinical immunology team supports immunotoxicity evaluations and preclinical development of biopharmaceuticals. Our technology platforms supports mmunochemistry, immunohistochemistry, flow cytometry, HELISA, qPCR and next generation sequencing services. Test articles include antibody, recombinant protein, peptide, ADC, antisense oligonucleotide, siRNA, vaccine and reengineered cells.
- Biopharmaceutical dose formulation analysis
- Biopharmaceutical PK and TK
- Immunogenicity
- Immunophenotyping
- T-cell Dependent Antibody Response (TDAR)
- Tissue Cross Reactivity (TCR)
- Biomarker analysis
Figure 2. Illustration of the biotherapeutics safety triangle. (Plavsic, M. 2016)
Raw Material Test
Our biosafety lab offers a series of tests to help our clients better evaluate and reduce the risk from raw materials
- Sterility
- Bioburden
- Mycoplasma
- Animal-derived adventitious virus testing
Viral Clearance Studies
Throughout the project development cycle, our highly trained and experienced viral clearance team helps our customers design viral clearance protocols and align them with downstream purification protocols and regulatory submission requirements
- Monoclonal antibodies
- Bispecific antibodies
- Fusion proteins
- Recombinant proteins
- Peptide products
Pathology
BOC Sciences’ pathology team provides pathology evaluation and interpretation, offering comprehensive interpretation of pathology data and full report preparation
- Clinical Pathology. Clinical chemistry, hematology, coagulation, urinalysis
- Autopsy
- Histology.
- Histopathological evaluation by in-house pathologists
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of safety assessment at competitive prices for global customers. Personalized and customized services of safety assessment can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Plavsic, M. An integrated approach to ensure the viral safety of biotherapeutics. BioPharm International. 2016.
