Syner-G provides CMC solutions to address drug substance (DS) and drug product (DP) development challenges. Working closely with our clients, we enable CMC decisions for important topics such as the selection of API starting materials, identification of critical process parameters (CPPs), critical quality attributes (CQAs), in-process controls (IPCs), control strategies for genotoxic impurities, DS/DP specifications, stability protocols, Quality by Design (QbD) approaches to product/process design, and more. We excel in providing these services for early- to mid-stage biotech and pharma companies who use a virtual drug development model.
As your virtual CMC development organization, we are adept at handling the strategic planning and tactical oversight needed to ensure efficient and timely CMC pharmaceutical development.
We offer scientific and technical consultation along with project management support for process and product development, analytical method development, and selection and management of contract development, manufacturing, and testing sites for drug substances and drug products. Our experts have real world experience in applying the state-of-the-art scientific and technological approaches and quality standards to develop the right quality target product profile (QTPP) for your drug, and design the product and process using QbD principles.
Our Customized Solutions Include:
- Leading drug substance synthesis and chemical/process development
- Selection of appropriate API starting material(s) and supplier(s)
- Oversight of preformulation/formulation activities
- Development of control strategy for genotoxic impurities
- Dissolution testing/bioequivalence
- Analytical method development
- Identification, selection, and management of contract manufacturing and quality testing sites (CMO/CRO) for clinical and commercial drug substance/drug product
- Oversight of technology transfer/method transfer
- CMC project management support for outsourced activities
- CMC technical due-diligence support for in-license/out-license
- Technical review of routine cGMP documentation, e.g. batch records, stability protocols, validation reports, etc.
- Study design and data analysis to characterize critical manufacturing process parameters and integration into product specifications and overall control strategy
- Criticality/risk analysis and development of risk mitigation strategies to minimize the impact of unexpected results on project timelines
Development of Complex Biologics as Therapeutic Modalities
Syner-G provides CMC, quality and regulatory solutions to efficiently drive the development of complex biologics, including (but not limited to) monoclonal antibodies, recombinant proteins, plasma-derived proteins, antibody-drug conjugates, bi-specifics, peptides, vaccines, and cell and gene therapies.
Syner-G offers end-to-end, scientifically-driven technical expertise in biologics from early preclinical development through approval and post-approval. Covering upstream and downstream process development, optimization, scale-up technical transfer, and validation of manufacturing processes, we work seamlessly with your team. We are well-versed in risk assessments and comparability protocols that meet regulatory requirements for process and site changes. Additionally, our experts can help define phase-appropriate analytical assays and guide development, qualification and validation.
Our fields of experience in biologics includes:
- Plasma derived therapeutics
- Recombinant proteins
- Cell and gene therapies
- Monoclonal antibodies
- Antibody-drug conjugates
- Peptide therapeutics
Our biologics services include:
- Upstream and downstream process development and optimization
- Analytical method development (development, optimization, qualification, and validation)
- Tech transfer
- Scale-up manufacturing
- Process validation
- Formulation development
- Comparability assessment
- Preclinical and nonclinical toxicology assessment
- Generation (authoring and review) of risk assessments, INDs, IMPDs, BLAs, annual reports, meeting requests, orphan drug applications