CMC Services

Biopharmaceuticals are an unprecedented success story. Due to their outstanding efficacy and safety and their high potential to address unmet medical needs, biopharmaceuticals are by far the fastest-growing part of the industry and are already making up 20 percent of the global pharma market.

But the effort and amount of technological skills required for the development and production of these complex molecules are both challenging and evolving rapidly, and so are the associated expectations of the regulators. Therefore, it is essential to account for regulatory requirements early on in development and to carve out the most efficient path to approval to ensure commercial success.

Based on a broad global project experience, we at PharmaLex recommend an integrated solution combining our scientific, technological and regulatory expertise to meet your specific support needs, both for specific aspects or for the complete development process.

The product types we support include:

• Recombinant proteins (e.g. mAbs (and derivatives), hormones, enzymes, fusion proteins)
• Tissue, cell and gene therapy products / ATMPs
• Biosimilars
• (Non-recombinant) biologicals isolated from living sources
• Peptides
• Antibody drug conjugates (ADC)
• Vaccines (recombinant proteins, live attenuates and recombinant vector vaccines)

Our services include:

• Development and regulatory strategy considering regional requirements (e.g. US, EU, Canada, Japan, Emerging Markets)
• Gap analysis / Due diligence
• Scientific and technical writing and compilation of regulatory documents
• Scientific advice and other Health Agency meetings
• Risk assessment
• Preparation of Target Product Profile (TPP)
• Comparability exercises
• General ‘troubleshooting’, including investigations and root cause analysis and support for CAPA
• Deviation and change control preparation / review
• Method / process validation
• Process characterization
• Project management

Chemistry Manufacturing and Controls (CMC) compliance is an important component in the lifecycle of a medicinal product, but is one that is continually challenged by many factors, including Merger and Acquisition (M&A) programs, increasingly complicated networks of internal and external manufacturing sites and insufficiently robust internal processes within an organization to manage complexity and cross-functional interfaces.

These factors often lead to compliance issues, which may have serious consequences from a delay in product approval requiring corrective actions up to product recalls and the loss of marketing authorizations. It is clear that the impact of non-compliances identified through Health Authority inspections can be extremely costly and can irrevocably damage a company’s reputation.

A strong partnership is required between the Regulatory and Quality functions with the necessary inputs to support the implementation of transformed systems and processes within an organization, which can ultimately provide a sustained CMC compliance outcome for a business.

Our team of CMC and Quality experts will help you make your compliance proactive and in line with Health Agencies’ requirements, supporting the uninterrupted supply of medicines to patients. Besides broad experience, we bring a standardized approach and ready-to-use templates for compliance gap analysis and remediation to the table. And we can provide the needed resources to manage such projects even under high time constraints.

Our services include:

• CMC Due diligence (e.g. in-licensing activities) / Gap analysis
• Product / patient impact assessment
• Development and implementation of risk-based gap remediation plan
• Root Cause Analysis of gaps in CMC information
• Preparation for regulatory health authority inspection (incl. CAPA-management)
• Optimization of the supply chain