BioProcess Technology Group. Helping Clients De-Risk Biopharmaceutical Development Since 1994

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1 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 and biotherapeutic development processes, 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 6 years, including assisting with over 100 global regulatory submissions In 2017, gene and cell therapy was our fastest growing sector We are subject matter experts with real world industry experience who deliver cutting-edge, solution-oriented consulting services directed specifically to our clients needs and mission From Clone to Commercial 2

3 From Clone to Commercial 3 Expert Advice and Guidance Throughout Development Early and Mid-Stage Development Ready for Validation and PAI Process & Analytical Development Quality & Regulatory Services Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Cell Line/Stem Cell Development CMC Regulatory Strategy Phase-appropriate Process Development Quality System Design and Management Analytical Method Development and Validation 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 From Clone to Commercial 4 Business Services to Support Strategic Initiatives biotrak Database Due Diligence How much API manufacturing capacity is there? Who is investing in capacity? What do product pipelines look like over time? How to identify CDMOs to meet complex product requirements? Support biopharmaceutical manufacturing market assessments 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 Estimate manufacturing costs Evaluate economic impact of new technologies or process changes Assess relative costs of manufacturing options Make or Build vs Buy decisions Identify market opportunities and client/customers needs Competitive intelligence and market research Evaluate technology trends and tools

5 Our Clients and Services BPTG has supported biopharmaceutical and biotherapeutic companies throughout the world with major clients in the US, Europe, and Asia Our clients include venture-backed, early-stage biotech, including cell and gene therapy companies to large fully integrated pharmaceutical companies, investors and service providers Company type Large Mid Small Investor Supplier other 5

6 BPTG: 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 6

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