HEJNAES CONSULT

is a consulting company within the field of biopharmaceutical Chemistry, Manufacturing and Control (CMC).

Our aim is to assist clients to develop and manufacture GMP quality drug substances and products for clinical trials, phase I+II in a safe and ethical manner.

Hejnaes Consult has specialized in sponsor projects outsourced to Contract Service Organizations offering contract manufacturing services, fill-finish, analytical support and regulatory applications. Focus is on high level project management with the aim of providing sponsor with a continuous project oversight (finance, timelines, deliverables, documentation and risk mitigation).

SERVICES

Due diligence

Evaluation of the target company's CMC strategy to assist investor in decision making

Project strategy

Define the CMC strategy for development and manufacture of the target protein drug substance and drug product

Financial support

Prepare CMC budgets, cash flows and continuous overview of real time expenses

Documentation

Establish and maintain the CMC repository supporting regulatory applications and funding

Project Management

Overall project management aiming on timely delivery of materials for pre-clinical studies and clinical trials

Protein chemistry

Assistance in process design, unit operation optimization, formulation and trouble shooting based on more than 40 years of protein chemistry experience

Regulatory filing

Assist in preparation of regulatory applications such as IMPD and IND

Risk assessment

Activities are associated with GAP analyses and risk assessments to support sponsor decision making

ABOUT

Hejnaes Consult was founded in 2011 by Kim Hejnaes with the aim of servicing the biotech industry within the field of Chemistry, Manufacture and Control (CMC). Although the main activities have focused on assisting newly started biotech companies with their CMC packages, Hejnaes Consult has also serviced investors, mid-size and large biotech companies with specific tasks such as due diligence, tech transfers and strategies.

NETWORK

Hejnaes Consult has a worldwide network comprising CMC consultants, contract organizations, biotech companies and universities.

Hejnaes Consult has entered into a collaboration with Bioneer (https://bioneer.dk/) and CMCassist offering early development services in the fields of cell line, process and formulation development.

CURRICULUM VITAE

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Kim Hejnaes (M. Sc. in Biochemistry from University of Copenhagen) has worked in the biopharmaceutical industry for more than 35 years as a protein chemistry principal scientist, project director, chief operating officer and chief executive officer hereof 20 years with Novo Nordisk and 5 years with CMC Biologics.

Kim Hejnaes is the co-founder of several biotech companies and served as an adjunct professor in Biotechnology at University of Aalborg, Denmark, from 2006 to 2016. Further, Kim Hejnaes is the co-organizer, speaker and trainee on outsourcing workshops associated to leading conferences, such as the World ADC, San Diego 2015 and PDA, Munich 2017.

Since 1998, Kim Hejnaes has been involved in all aspects of Chemistry, Manufacturing and Control (CMC) operations with solid involvement in more than 50 international biotech projects (peptides and proteins) over the years. The current focus is on outsourcing of CMC activities from early development to delivery of products for pre-clinical studies and clinical phase I-III trials. The solid protein chemistry background combined with 20 years of experience in project management and outsourcing has contributed to timely deliveries and projects executed on budget and makes Kim Hejnaes one of the leading experts within the field.

Kim Hejnaes is the founder and CEO of Hejnaes Consult servicing biotech companies and international investors within the CMC area.

CONTACT

Hejnaes Consult AB
Baarared 904
SE 31397 Simlaangsdalen
Sweden

Kim Hejnaes, CEO
kim@hejnaes.dk
+46 761908090