With experience in all phases of product development for a range of biotherapeutics and commitment to advance the products through development, STC Biologics is your preferred strategic partner. We take pride in our ability to become an expert on your product, to go above & beyond in order to drive it through various stages of product development and ultimately successfully tell the story of your product in regulatory submissions.
Preclinical Development Phase
During preclinical development of novel products, molecule selection showing efficacy and good safety profile as well as“developability” are the key milestones. STC Biologics can provide an integrated solution from target ID to transient production of materials for preclinical testing and in vitro assays for safety and efficacy evaluation.
Biological and immunological assays for efficacy and specificity assessment
Biomarker assay development
Sequence design, humanization and de-immunization
Transient expression and production of early material for feasibility and POC studies
Cell line development
Early formulation development to support pre-clinical studies
Once a preclinical proof of concept is demonstrated, we help our client to reach the clinic on expedited timelines.STC Biologics will apply a systematic approach to CMC development along with its experience with a wide range of biotherapeutics to move your product through the IND-enabling phase. Even though STC Biologics utilizes a MAb development platform to expedite process development and analytical development, we pay special attention to product differences and potential issues that may be product specific; we understand that no one drug is similar enough to apply the same platform technology. Parallel formulation and analytical development activities reveal the product characteristics and risks, which then focus our efforts on minimizing those risks to progress your product.
Stable cell line development and oversight of cell line characterization
Upstream and downstream development of the drug substance manufacturing process
Pre-formulation and clinical formulation development
Analytical development of release and stability assays, product characterization and in-process testing in support of process development
Production of materials for toxicology and other non-clinical pharmacology, safety and efficacy studies.
Stability studies to support toxicology studies, initial retest date for IND submission, and test article labeling, shipment, handling and storage conditions
Process transfer and support of GMP production of clinical supplies
Assay qualification, analytical transfer and support of GMP testing
Bioanalytical assay development for PK, efficacy, and safety assessment
Preparation of pre-IND briefing book and regulatory agency meetings
Support of Investigation Brochure, in-use studies, product labeling and packaging
Preparation of CMC section of IND and IND submission
Clinical Development Phase
During Phase I and Phase II clinical studies, attention is turned to the development of Phase III and commercial process and product. STC Biologics can support your strategic product planning, process and analytical optimization, refinement of dosage form, and process characterization studies to define process validation criteria.
Prior to or during pivotal Phase III clinical studies, STC can manage CMOs by reviewing process validation protocols and execution results and process clearance studies; STC can support pharmaceutical development studies (e.g. ICH photostability studies, shipping validation) and full product and impurities characterization.
Process optimization, COGs reduction, scale up support
Process validation protocol development and oversight of CMO for execution
BLA-enabling studies, including full product/impurities characterization, photostability, shipping validation, and commercial specifications.
Preparation for pre-BLA meetings and authoring CMC sections of the BLA/NDA
Following NDA/BLA submission, the company needs to be ready for pre-approval inspections at the GMP facilities.Even upon approval, there are generally a number of post-marketing commitments and continuous process verification that require full attention to the design and execution of those studies.
Partnering with CMOs and sponsor for pre-approval inspection readiness (Gap analysis, preparation for filling gaps and answering questions)
Response to regulatory agency questions
Conduct of studies for post-approval CMC commitments
Comparability Protocols and study execution
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