Solution for Biotech Industries 

Bioprocess, Engineering & Project Management

Consulting Services 

We help our clients with:

  •  cGMP Manufacturing Processes,
  •  Technology Transfer,
  • Process Development,
  •  Process Validation (mAbs, Recombinant Proteins, Viral Vectors)
  • We provide GMP inspection readiness audits
  • GMP Training in partnership with Biotech Academy in Rome
  • We support all stages of investment projects from the decision-making process to facilities design and construction, in partnership with Nordika Engineering Group
  • We provide Business Development services based on our network of CDMOs
  • We provide Due Diligences service for M&A deals, in collaboration with Summit Partners
  • Pharma Broker and support in the search and selection of the most suitable API dossier (biosimilars, biologics, small molecules…)

International Experience Supporting Biotech Companies

BetaPro Consulting collaborates with Countries across the European Union, Latin America, Africa and the Middle East, while maintaining a daily partnership with the United States, Brazil, Chile, Denmark and UK.

Cell Line Engineering

Our team consists of experienced scientists and professionals with a proven track record in cell biology and biotechnology. With a wealth of experience, we bring valuable insights to your projects, ensuring a thorough and meticulous approach to Cell Line Development. Our consultancy offers tailored solutions for developing robust cell lines optimized to produce biotechnological products. We understand the unique requirements of your projects and work closely with you to ensure the development of cell lines that meet your specific needs.

We provide technical and scientific support for the choice of the right expression system for your recombinant product. We offer assistance in the evaluation of the compliance of your regulatory documentation to the relevant international guidelines (ICH Q5B, ICH Q5D). Our experts will guide you to critically review your Cell Line Development plan in order to fulfill the international industry standards.

Process Development

Benefit from our successful track record in optimizing biotechnological processes for diverse applications. Stay at the forefront of innovation with our forward-thinking strategies and solutions.

Navigate complex regulatory landscapes with confidence, ensuring compliance at every stage.

We believe in fostering strong, collaborative partnerships to achieve shared success.

Our team works closely with yours, ensuring transparency and effective communication throughout the consultancy process.

We offer:

Feasibility Studies: Rigorous assessments to determine the viability of your biotechnological product, helping you make informed decisions from the outset.

Optimization Strategies: Fine-tune your processes for maximum efficiency, reducing costs and accelerating time-to-market without compromising on quality.

Scale-Up Solutions: Navigate the complexities of scaling up your bioprocess to ensure a smooth transition from laboratory to industrial-scale production.

Quality Assurance: Uphold the highest standards of quality throughout your product's development lifecycle with our comprehensive quality assurance protocols.

Regulatory Compliance: Navigate regulatory landscapes confidently with our in-depth knowledge of industry guidelines and compliance requirements.

Technology Transfer

Harnessing the power of our experienced team, we offer a comprehensive suite of consultancy services tailored to meet the unique needs of biotech pioneers. Whether you are a research institution, a biotech startup, or an established player, our expertise spans the entire technology transfer journey.

  1. Strategic Planning:
    • Crafting tailored roadmaps for efficient technology transfer.
    • Identifying key milestones and potential hurdles.
  2. Intellectual Property Management:
    • Comprehensive analysis and protection of intellectual assets.
    • Licensing strategies to maximize revenue and impact.
  3. Market Assessment:
    • Through market research to gauge product viability.
    • Identifying target demographics and market trends.
  4. Regulatory Guidance:
    • Navigating complex regulatory landscapes for compliance.
    • Ensuring smooth transitions from lab to market.
  5. Partner Identification and Negotiation:
    • Identifying potential collaborators and licensees.
    • Conducting negotiations that optimize value for all parties.
  6. Commercialization Support:
    • Developing go-to-market strategies.
    • Providing ongoing support for successful product launches.

GMP Production

Our team of seasoned professionals specializes in GMP compliance for the production of biotechnological products. From monoclonal antibodies, recombinant proteins to viral vectors, plasmid DNA, mRNA, and CAR-T cells we understand the unique challenges posed by diverse biotech processes and are adept at crafting customized solutions. Forge a strategic partnership with us to ensure ongoing support, keeping your biotech production at the forefront of industry standards. We offer comprehensive consultancy services tailored to elevate your biotech manufacturing processes.

Service Offerings:

  1. GMP Compliance Audits: Rigorous assessments of your current manufacturing processes to ensure compliance with the latest GMP standards. Our detailed audits identify areas for improvement, helping you establish a robust foundation for biotech production.
  2. Process Optimization: Fine-tune your biotechnological production processes to enhance efficiency, reduce costs, and maximize yields. Our experts work closely with your team to identify optimization opportunities without compromising product quality or regulatory compliance.
  3. Quality Management Systems (QMS) Implementation: Establish comprehensive Quality Management Systems tailored to your unique biotech production requirements. Ensure adherence to GMP guidelines, streamline documentation processes, and foster a culture of quality throughout your organization.
  4. Regulatory Affairs Consulting: Navigate the complex regulatory landscape with confidence. Our regulatory affairs experts provide guidance on compliance with global regulatory requirements, submissions, and interactions with regulatory agencies, ensuring a smooth approval process.

Process Validation

At BetaPro Consulting, we understand the critical role that Process Validation plays in ensuring the safety, efficacy, and quality of biotechnological products. With our expertise and commitment to excellence, we offer comprehensive consultancy services tailored to meet the unique needs of your biotech ventures.

Our Service Offerings:

  1. Process Characterization: Collaborate with us from the conceptual stage to design robust and scalable biotechnological processes through Quality by Design approach.
  2. Risk Assessment and Management: Identify and mitigate potential risks associated with your processes, ensuring a proactive approach to validation.
  3. Validation Master Plans: Develop comprehensive plans outlining the validation approach for your biotechnological products, ensuring a systematic and strategic validation process.
  4. Qualification Protocols and Execution: Draft and execute protocols for equipment, facilities, and utilities qualification, ensuring the reliability and consistency of your processes.
  5. Cleaning Validation: Implement effective cleaning validation protocols to guarantee the removal of contaminants, preserving the integrity of your products.
  6. Process Monitoring and Optimization: Continuous monitoring and optimization strategies to enhance the efficiency and quality of your biotechnological processes.