A One-Stop Solution For Biologics Services
For over 16 years, GenScript has been a world leader in generating high quality, application-driven, cost-effective custom services for biologics discovery and development. Their proprietary technology platforms in a variety of domains makes the company very competitive in the biologics space.
GensScript aims to serve as a one-stop provider from target discovery to IND application, maintaining conformity to the regulations for applications to regulatory agencies, such as the United States Food and Drug Administration (FDA), China Food and Drug Administration (CFDA), and the European Medicines Agency (EMA).
Leveraging GenScript’s in-depth understanding of industrial standards of biological drug discovery and development, world’s top pharmaceuticals and academic institutions use GenScript’s discovery and development services along with their GMP-compliant manufacturing services.
GenScript has 16+ years of experience in high throughput production of plasmid DNA with 5000+ organization-level customers. Their services are used in various sectors, including gene therapy, CAR-T cell therapy, vaccine development, biodistribution studies and bioprocess manufacturing applications.
GenScript offers the most affordable and high-quality GMP grade plasmid DNA production service to meet various needs with rapid turnaround time. Their capacity to produce GMP plasmids is flexible, with production scale ranging from micrograms to grams level. GenScript’s strengths include:
- High plasmid quality (with more than 90% supercoiled content)
- Short turnaround time
- Product safety, with no antibiotics and animal derived components
- High fermentation titers
GenScript’s development and manufacturing platform includes cell banking, fermentation, purification and strict quality study services. They are capable of producing lentivirus and AAV virus with high titers suitable for in vitro and in vivo experiments. Their typical turnaround time is 3 weeks.
For lentivirus production, GenScript can provide a one-stop solution from DNA synthesis to lentivirus production. Lentivirus systems with 2nd and 3rd generation are available with different promoters or tags. GenScript’s lentivirus production solution includes:
- Synthesis of genetic materials like cDNA, shRNA and miRNA
- Cloning the gene of interest into the lentivirus transfer plasmid
- Production of virus
- Purification and titration
GenScript’s excellent track record includes 5 IND cases and 1 CAR-T project in clinical trial.
GenScript’s biologics platform can provide one-stop service of chemistry, manufacturing and controls (CMC) for the biopharmaceutical target. GenScript works with sponsors to determine the lead sequence after early research into developability assessment and pre-toxicity studies, and then enters the CMC stage to provide preclinical data for IND applications.
GenScript is capable of providing all the services involved in pre-IND studies, including:
- Stable cell line development
- Process development of cell culture and purification
- Quality studies and method validation
- Formulation development
- GMP pilot production
- Bioassay development
- PK/PD and toxicology studies
The average clone titer of a GenScript-produced mAb is 3-6 g/L with guaranteed 50+ generation clone stability. Process development is compliant with QbD concepts to optimize critical process parameters (CPPs) and monitor critical quality attributes (CQAs) throughout the whole project to ensure robustness of cell culture and purification processes.
GenScript’s comprehensive analysis platform is equipped with state-of-the-art instruments to fulfill the needs of quality studies for biomacromolecule characterization and process impurity analysis. In addition, cell-based bioassays have been established for many immune checkpoints and are customizable for client-specific targets.
The qualified CMC service supports the IND application under FDA, cFDA and EMA. Generally, the entire CMC process requires 14-18 months, from gene to pre-IND phases. GenScript’s cGMP manufacturing capability will be available to meet the demand of Phase I trials (in 2019), and Phase II, Phase III and commercial production (in 2020-2021).
Therapeutic antibody drugs have recently experienced explosive growth. Within oncology research alone, more than 20 therapeutic antibody drugs received FDA approval for new treatments or indications during 2015 to 2017. Additionally, more than 300 therapeutic antibody drugs are in ongoing clinical trials. Most recently the success of cancer immunotherapy, by blocking immune checkpoint proteins such as PD-1 and CTLA-4, created a hope for a “cancer cure” and triggered a second revolution so that the majority of pharmaceutical companies are investing many research resources in antibody therapeutics.
Amidst fierce competition together with many unmet medical needs, there is an urgent demand for new therapeutic strategies, such as combination therapy, and novel modalities, such as bispecific antibodies.
GenScript’s proprietary SMAB (single-domain antibody fused to monoclonal antibody) bispecific antibody platform minimizes the immunogenicity and manufacturing concerns of current bispecific antibody platforms while enabling bivalent and multi-valent therapeutics.
Major advantages of the SMAB platform include superior bioavailability and excellent developability for high yield and stability. Molecules generated on the SMAB platform have the ability to bind to hidden epitopes, such as enzymes and ion channels. Also, the platform is flexible enough to enable construction of multivalent molecules in a plug-and-play fashion. SMAB bispecific antibodies have demonstrated high efficacy and and high affinity to target cells in many models.
To build a new Biologics GMP Facility, GenScript has invested $75 million to establish a modern biologics discovery, development, clinical and commercial manufacturing center in the city of Zhenjiang, Jiangsu Province, China. The Manufacturing Center is scheduled to come into use by 2020.