Chemistry · Manufacturing · Control
Hejnaes Consult is committed to the principle of safety first.
Hejnaes Consult AB is a Swedish limited company offering consulting services within the area of biopharmaceutical Chemistry, manufacture and Control (CMC).
The objective is to assist small scale biopharmaceutical companies to prepare the project plan and associated activities required for raising capital, writing requests for proposals, preparing timelines and budgets, etc. - a necessary background for initiating the demanding and complex CMC development and manufacturing program.
The services are handled by the founder and CEO, Kim Hejnaes.
Hejnaes Consult is committed to the principle of safety first.
Consequently, the services will be executed in due respect of ICH guidelines having product safety, quality and stability as the first priority.
KIM RY HEJNAES (M. Sc. in Biochemistry from University of Copenhagen) has worked in the biopharmaceutical industry for more than 40 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 (now AGC 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 was 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 60 international biotech projects (peptides and proteins) over the years. The solid protein chemistry background combined with 25 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.
The transformation of a scientific discovery into a biopharmaceutical project is a very complex exercise executed by experts in the field. Today, a great part of the projects is handled by startup biotech companies outsourcing their activities to selected partners such as contract manufacturing organizations. One of the first activities to be outsourced is the development and manufacture of the biopharmaceutical drug for pre-clinical studies and clinical trials (the CMC part). Clinical trials cannot start before approved GMP quality drug product is available, Consequently, the CMC part of the project is on the critical path.
It is the ambition of Hejnaes Consult to assist the Client preparing for the CMC program and to identify gaps having impact on the risk assessment. The aim is to ensure timely delivery on budget by preparing a comprehensive CMC project plan and associated documents specified under Services. The combined package and information herein will be used for vendor identification, requests for proposals, quotation negotiations and further activities required to execute the program.
Contact ↓A solid project plan is a prerequisite for the services listed.
The project plan is a thorough description of the activities required to run the project. The plan serves as a template for writing accurate requests for proposals, creating timelines, budgets, and GAP analyses. The plan also serves as an indicator of project matureness - too many GAPs make it more difficult to raise capital and to define the scope of work to be carried out by the outsourcing partners.
The project plan will be prepared from the tech transfer information.
Future service partners need well-structured and precise information about sponsors requested scope of work and documentation. Hejnaes Consult can assist in writing requests for proposals to ensure that the resulting quotations are accurate and in a quality for creating timelines and budgets.
In the biotech industry, where the CMC development and scale up program is both time consuming and expensive. Unrealisitic timelines will almost certainly lead to costly delays and missed opportunities and sometimes project failure. Realistic timelines must take process robustness, process scalability, product quality and product stability into consideration to minimize the risk for rejection of regulatory applications.
Hejnaes Consult aims to present timelines building on safety, product quality and stability.
A trustworthy budget and cash flow is a prerequisite for timely delivery of drug substance/product for pre-clinical studies and clinical trials. Unrealistic budgets can lead to project cancellation if investors choose not to refinance the project. The cash flow will be based on a combination of budget data and timelines.
Be prepared!
CMC budgets comprise not only the items listed in vendor quotations, so solid CMC background knowledge is required to make the complete budget and cash flow (input from several vendors are often required).
In this context the GAP analysis identifies important gaps in the project plan having an impact on project execution, product safety, quality and stability.
The high-level risk assessment will be prepared using information from the project plan, timelines, quotations, budget, and GAP analysis.
Contact
Kim Hejnaes
Founder and CEO · Hejnaes Consult AB