Manufacturing Concepts: Invest and Optimization

Evaluation: Situation, requirements, project scope and objectives

Capacity: Optimization, current facility expansion, new facility

Modelling: Capacity increase and manufacturing cost optimization

Concept Designs: New facilities and expansions

Future Work

Analysis: Activities, actual capacity utilization, quick wins

Requirements: In-depth interviews, personas for funtional roles

Quantitative framework: Activity-Based-Working, zoning, new facility

AWB zone concept: Supportive environments per activity type

Implementation concept: Mood boards, requirements, layout drafts

CMC Consulting

External Head of CMC

CMO-Management

Mitigation of operational CMC risks

Clinical Operations Support

Manufacturing Consulting

We advise and support our customers in all aspects of biotech and pharmaceutical production. Covering the entire product life cycle, from process development to process transfer, investments and production optimization.

Our services include:

CMC management for small biotechs and CDMOs
Consulting for tech transfer of APIs and drugs
Factory planning from investment concept to start-up and qualification
Process engineering
Operational excellence and optimization of production as well as intralogistics
Project management
Strategy consulting for CMC, technology development and investments

Clients

Our focus industries are pharmaceuticals and biotechnology. Here we have extensive technology and process knowledge, many years of consulting experience and cooperate in an established network of experts.

Our clients are as diverse as our consulting services: Biotech startups, mid-sized companies and corporations – drug development companies, contract development and manufacturing organizations and equipment manufacturers.

Approach

Consulting as we understand it has no standard blueprint:

For each challenge defined with our clients, we develop custom-made solutions that build upon the company’s current situation and support its strategic goals.

Custom-made

Effective consulting is individual and tailored to client needs, it does not follow a rigid scheme. We always start with the specific strategic, technical and organizational challenges of our customers, prioritize them jointly and then develop effective solutions.

Complementary

We utilize the know-how of the client organization and supplement it with proven methods and functional expertise. In small but empowered client-consultant-teams, joined by additional experts, suppliers or end users where needed.

Systemic

Every company is shaped by people with diverse skills and beliefs. Behavioral patterns, interactions and other success factors are not always openly revealed. We use systemic approaches to get to the bottom of problems and find solutions.

Team

gregor@dudziaknetwork.com

Dr. Gregor Dudziak · Managing Partner

Gregor knows from firsthand experience how process development, factory planning and production intertwine for a successful product launch. Utilizing more than twenty years of extensive experience in biotech and pharmaceutical companies and as a consultant, he develops individual technical and organizational solutions for and with his clients, for development and production, quality systems and capital investment projects.
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santiago@dudziaknetwork.com

Santiago Gómez Scholz · Senior Consultant

As a consultant, Santiago is already well on his way to being a generalist for technology projects – with lots of experience particularly in process technology, plant/equipment safety and project management. In addition to a number of concept designs he has already managed important parts of a 220 m€ investment project.
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ulrike@dudziaknetwork.com

Ulrike Wieborg · Senior Consultant

As an expert for biopharma invest projects, Ulrike adds a broad range of experience from concept design to implementation and qualification. She gained expertise in process engineering and clean room design and is well versed in project management.
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julia@dudziaknetwork.com

Julia Hagemeister · Analyst

Julia adds her knowledge as a bioengineer as well as her experience from laboratory and project work to our company. She supports our projects as an Analyst.
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pedro@dudziaknetwork.com

Pedro González · Analyst

Pedro, a native of Caracas, Venezuela, graduated with a master’s degree in Bioengineering, focusing on biopharmaceutical process engineering. His interest in innovative therapeutic approaches and the potential of biotechnology motivates him in his work as an analyst at D&N.
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Network

We work in a network with experts and companies, with whom, in many cases, we have a long-standing working relationship. With this network we can further expand our core competencies and advise our clients comprehensively in a broad field of challenges.

Martin Graw · Biotech Manufacturing Consulting

Due to more than 20 years of experience in process engineering and manufacturing, Martin has extensive experience in the design, qualification and commissioning of production facilities for biotechnological drugs – complemented by the know-how to build production teams.
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Christian Hinrichsen · Strategy and Organizational Consulting

Christian is an architect for organization and governance: He uses his 20 years of experience as founder, project lead, turnaround manager, strategy consultant and systemic coach to design and build indivual solutions for companies of all sizes. From strategy development and an effective organizational model to a pragmatic steering approach and the coaching of leaders and their teams through the change phase.
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Dr. Alrik Koppenhöfer · Business Development and Marketing Consulting

Alrik Koppenhoefer offers consulting services to executives and investors in the biotech industry since 2004. He has been working in the Life Science industry and academia for over 20 years, conducting more than 50 projects. He is the founder of the Life Science Consulting Network (LSCN) and was involved in setting up several new companies.
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Dr. Manfred Papaspyrou · Business Development and CMC Management

With over 30 years of experience in the biopharmaceutical industry, Manfred advises his clients in business development and sales for new and established products and services – in development, technology transfer and GMP production of drug substances and products. Thanks to his own experience as entrepreneur, he is familiar with many of the challenges that biopharma start-ups and technology companies are facing.
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Values and Principles

Quality

It is our aim to work with our customers on a long-term basis in a trusting partnership. We achieve this through the quality of our services.

We usually advise our customers over several years – continuously or repeatedly in different projects. As a matter of fact, we have been working with over 80% of our clients for one year or longer.

Diversity

We are committed to diversity, because we believe we can find better solutions from a wide variety of complementary perspectives. For our customers and for our company.

Sustainability

Our preferred means of travel is by train. Whenever we need to fly or use a rental car, we offset the CO2 emissions.

We optimize our travel and work from wherever we can support our clients and colleagues best. When we meet in our Heidelberg office, we use public transport or come by bike.

Our office is part of a low energy coworking space constructed according to the passive house standard and located close to Heidelberg main station.

Distributed Working

We work in a self-determined and customer-oriented manner in a wide variety of places: At home, at our customers‘ sites, in our office in Heidelberg, while traveling, and sometimes completely elsewhere.

References

Affimed
Amgen (inhouse)
Bayer (inhouse)
Beiersdorf
BIBITEC
Boehringer Ingelheim
CatalYm
EVER Pharma
Glycotope (Celonic)
KyooBe

Merck KGaA
Minaris Regenerative Medicine
Nordmark Pharma (1) (2) (3)
Northway Biotech
Octapharma
PHARMAQ
Rentschler (inhouse)
Syntegon
Wacker Biotech
WALA

D&N References · Personal References