Certara leverages cutting-edge solutions to address the unique challenges of complex biologics, including CAR-T therapies, monoclonal antibodies, bi/multi-specifics, antibody-drug conjugates (ADCs), radiopharmaceuticals, oligonucleotides, gene therapies, and cell therapies. Our model-informed drug development approach integrates regulatory insight, pharmacometric expertise, and quantitative systems pharmacology to achieve program milestones efficiently. By tailoring each strategy, we help you navigate regulatory pathways and accelerate clinical development.
Complex Biologics Services
Expert guidance for developing novel modalities
With a proven track record in over 200 programs since 2018, we deliver model-informed strategies that enhance efficiency and success across novel modalities.
Learn more about Complex Biologics services
Revolutionizing complex biologics development
Expertise across multiple novel modalities
Our team brings deep expertise across multiple novel modalities. We ensure precision and strategic guidance to accelerate development across diverse therapeutic landscapes.
Regulatory mastery
We align your biologics strategy with global regulatory requirements, minimizing risk and enhancing submission success rates.
Model-informed strategies
Certara employs in silico modeling to optimize Phase II/III studies, reduce costs, and streamline post-marketing requirements.
Proven success
Having supported over 200 programs since 2018, our track record demonstrates unparalleled expertise in complex biologics and novel modalities, including bi/multi-specifics, ADCs, radiopharmaceuticals, oligonucleotides, and engineered protein development.
Trusted experience
Our team supported 23 oligonucleotide programs in just three years, delivering innovative solutions for RNAi, siRNA, miRNA, and antisense oligos.
Market success
Health economic outcomes research ensures competitive market alignment for your novel modalities.
Neurological disorder therapies
We linked plasma dosing with exposure and efficacy for therapies targeting neurological disorders, achieving optimal clinical outcomes.
Preclinical animal studies
Our team designed preclinical studies to enhance data sets for PK/PD modeling, predicting target engagement with precision.
Certara: Your trusted partner in complex biologics
and emerging modalities
Certara’s innovative approaches and deep expertise drive success in complex biologics and novel modalities. Explore our comprehensive solutions below:
Advancing novel modalities with proven expertise
CAR-T therapies
Accelerate CAR-T therapy development with deep expertise and advanced modeling & simulation, optimizing safety, efficacy, and regulatory success while addressing complex PK, biodistribution, and exposure-response challenges.
Monoclonal antibodies
Leverage industry-leading expertise in modeling & simulation, translational science, and regulatory strategy to accelerate the development of monoclonal antibodies (mAbs), optimizing their safety, efficacy, and commercial success.
Bi/multi-specifics
Apply advanced modeling & simulation, translational science, and regulatory expertise to accelerate the development of bi- and multi-specific antibodies, optimizing their efficacy, safety, and regulatory success.
Antibody-drug conjugates (ADCs)
Accelerate the development of ADCs by leveraging advanced modeling & simulation, translational science, and regulatory expertise to optimize dosing, safety, and clinical outcomes. Our data-driven approaches support efficient development, from preclinical modeling to regulatory submissions, ensuring faster time to market and improved patient outcomes.
Radiopharmaceuticals
Optimize dosing, predict safety, streamline regulatory pathways, and apply advanced modeling to enhance both therapeutic and diagnostic applications, ensuring faster time to market and improved patient outcomes.
Oligonucleotides
Partner with leaders in oligonucleotide therapeutic development responsible driving the success of the first FDA-approved oligonucleotide therapy and numerous other programs through advanced methodologies like in-silico clinical trial modeling, pharmacometric analysis, and strategic regulatory support.
Cell and Gene Therapies
Accelerate the journey from discovery to market access with an integrated approach and expert team, helping you anticipate risks, make informed decisions, and set your cell and gene programs up for success.
Meet our multidisciplinary team with unparalleled expertise in complex biologics and novel modalities development
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Experts
Kathryn Brown, PhD
Vice President, Clinical Pharmacology, Certara Drug Development Solutions
Dr. Brown leads the Complex Biologics Center of Excellence which specializes in providing clients with expert support in areas such as cell therapies, RNA technologies, gene therapies, fusion proteins, ADCs, bispecific antibodies, etc.
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Experts
Mirjam Trame, PharmD, PhD
Vice President, Certara Drug Development Solutions, Head of Pharmacometrics USA Division II
Dr. Trame has deep expertise across various modalities, with a specialization in Cell and Gene Therapy, including complex biologics.
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Certara’s Complex Biologics services provide expert guidance to navigate the intricate landscape of biologic therapy development and other novel modalities. From preclinical stages to regulatory submissions, our specialized support ensures optimal outcomes for your program.
Supported 90% of Biologics License Applications (BLA) in 2019.
Proven success in over 200 programs since 2018.
Recognized leaders in model-informed drug development.
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Frequently asked questions
What are complex biologics and novel modalities?
Complex biologics and other novel modalities include CAR-T therapies, monoclonal antibodies, gene therapies, and RNA-based treatments, among others. These innovative therapies face unique challenges in development, manufacturing, and regulatory approval.
How does Certara support complex biologics and novel modalities?
Certara provides model-informed development, regulatory guidance, and advanced computational modeling to optimize every stage of biologics and novel modality development, including cell and gene therapies, RNA-based treatments, and more.
What experience does Certara have in biologics?
Certara has supported over 200 complex biologics and novel modality programs and contributed to 90% of BLAs in 2019.
