By 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.

In-house capabilities:

• Target ID
• 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

NOTE: for Biological assays, see Capabilities by Disease Area

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.

In-house capabilities:

• 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

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.

In-house capabilities:

• Process optimization, COGs reduction, scale up support
• Comparability protocol development, Comparability studies
• 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. 

In-house capabilities:

• 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