BioProcess Technology Consultants, Inc. Helping Clients De-Risk Biopharmaceutical Development Since 1994

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1 , Inc. Helping Clients De-Risk Biopharmaceutical Development Since 1994

2 Who We Are The biopharmaceutical and biotherapeutic development experts We are a team of results-oriented professionals assisting clients since 1994 to advance and de-risk the biotherapeutic development process, address unmet medical needs and increase patient access to novel medicines We have completed over 1,000 consulting projects with more than 300 companies in the last 5 years, including assisting with over 100 global regulatory submissions As subject matter experts with real-world industry experience, we deliver cutting-edge, solution-oriented consulting services customized to our clients needs From Clone to Commercial 2

3 From Clone to Commercial 3 Expert Advice and Guidance Throughout Development Process & Analytical Development Quality & Regulatory Services Early and Mid-Stage Development Cell Line Development CMC Regulatory Strategy Phase-appropriate Process Development Design and Manage Quality Systems Ready for Validation and PAI Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Develop and Validate Analytical Methods Compliance Audits Risk Assessments Validation Planning and Support Preparation of Global Regulatory Submissions Manufacturing Strategy & Operations Make vs. Buy Supply chain Options Facility Conceptual Design/Validation Identify and Manage Service Providers Project Management and Communications

4 Business Services to Support Strategic Initiatives biotrak Reports Due Diligence Biannual reports providing regular updates and analysis of global manufacturing capacity Understand the biopharmaceutical product pipeline Valuable tool for assessing product markets Support mergers and acquisitions Critically review CMC status and probability of regulatory success Define critical steps and activities for product advancement Process Economic Modeling Market & Technology Analysis Assess Cost of Goods and capability of current manufacturing to meet anticipated forecasts Evaluate economic impact of new technologies or process changes Assess relative costs of manufacturing options to inform manufacturing strategies Identify market opportunities and client/customers needs Competitive intelligence and market research Analyze trends to identify unmet needs and assess hurdles for acceptance of new products or technologies From Clone to Commercial 4

5 From Clone to Commercial 5 Client Demographics % of Total Our clients include venture-backed, early-stage biotech companies, cell and gene therapy companies, fully-integrated pharmaceutical companies, investors and service providers Distribution of Projects by Client Type Product Co Vendors/Suppliers Others 9% 12% 54% 5% 20% Large Bio/Pharma Mid-size Bio/Pharma Small Bio/Pharma Supplier/CMO Other

6 From Clone to Commercial 6 Client and Product Distribution BPTC has supported biopharmaceutical and biotherapeutic companies throughout the world with major clients in the US, Europe, Asia and Australia Distribution of Products Supported in Five Year Period rproteins Mabs Vaccines Cell/Gene Other

7 BPTC: The Clear Path to Success Making the right choices for Product and therapeutic development from IND to commercialization Transitioning from clinical development to PAI success Launch and post approval changes Access a team with unparalleled knowledge and experience with biopharmaceutical development, manufacture and supply services Committed to staying at the forefront of knowledge Providing straightforward guidance through a complex technical and regulatory environment From Clone to Commercial 7

8 Thank You! For more information, please contact: Al Doig, Inc. 12 Gill Street, Suite 5450 Woburn, MA p: m: