BioNTech

Support for SARS-CoV-2 vaccine production

The project at BioNTech is of high urgency due to the Corona Pandemic. Despite the associated enormous pressure, the quality of all work and production processes must not suffer as a result.

Consistent support from our experts makes sense both in the run-up to an intended project and during implementation. This gives you the information you need to make important decisions.

No project without changes. However, changes must never be implemented “on demand”. Our specially developed change management system has already proven itself in several projects as user-friendly and uncomplicated. In this way, you always have control and an overview of all requested and approved changes and their impact on costs and deadlines.

Risk and Opportunity Management

Being able to use project management software is not enough for professional risk management. It takes experience to correctly assess the probability of risks occurring and to derive appropriate buffer times or budgets from this. In cooperation with Behrens project management, you will find out in advance which events can affect your schedule or significantly increase your costs. So you are prepared for many eventualities.

However, projects not only harbor risks, but also opportunities. Evaluating these and monitoring their occurrence is also part of our expertise.

Who leads a pharmaceutical bulk packaging project?

For Boehringer Ingelheim, we took over the project management for bulk packaging with the content of inventory, risk analysis, as well as ensuring quality and compliance with regard to pharmaceutical packaging, sampling aids and packaging aids.

In addition, Behrens Projektmanagement got hands-on-training internal employees and the suppliers management.

Merz

Who can step in at short notice?

Merz Pharmaceuticals GmbH Frankfurt was at the beginning of a complex development project for a dermal filler (medical device according to MPG / ISO 13485) when a vacancy in project management arose. Consistent support from our experts makes sense both in the run-up to an intended project and during implementation. This gives you the information you need to make important decisions. No project without changes. However, changes must never be implemented “on demand”.

Our specially developed change management system has already proven itself in several projects as user-friendly and uncomplicated. In this way, you always have control and an overview of all requested and approved changes and their impact on costs and deadlines.

Risk and Opportunity Management

Being able to use project management software is not enough for professional risk management. It takes experience to correctly assess the probability of risks occurring and to derive appropriate buffer times or budgets from this.

In cooperation with Behrens project management, you will find out in advance which events can affect your schedule or significantly increase your costs. So you are prepared for many eventualities. However, projects not only harbor risks, but also opportunities. Evaluating these and monitoring their occurrence is also part of our expertise.

Installation, commissioning, qualification and more

A large company like CSL Behring always has many different projects from different areas running simultaneously. In order to meet these demands, CSL Behring employed several Behrens project management employees who were deployed in different areas and projects, for example in the installation, commissioning and qualification of systems. This included coordinating the trades involved, carrying out FATs and SATs, supervising engineering runs and planning and carrying out system qualifications.

Other areas of responsibility for the employees of Behrens Projektmanagement at CSL Behring were scheduling, cost and resource planning, project controlling and the establishment of a PMO.

Who coordinates the multi-project management in the ​​R&D area?

The simultaneous management of three projects (solid drugs development including packaging, manufacturing of hard gelatine capsules and a packaging project) contracted with Catalent Manufacturing requires an overview through clear structures.

Behrens Projektmanagement took on these tasks, with a strong focus on costs and tracking deadlines. A very particular challenge was managing the stakeholder with external and internal customers, in order to achieve to the maximum the project goals agreed.

Who optimizes the stability program?

Behrens Projektmanagement updated and optimized the stability program on site, according to international guidelines.

The tasks of Behrens Projektmanagement were recoring the current situation and evaluating the validation status of the analytical methods used in quality control. Furthermore, we took over the planning and supporting of validation activities in the field of serology, microbiology and physical chemistry.

Who supports in groundbreaking decisions? 

Clarity of decisions is required for projects of investment. In order to bridge personal bottlenecks, external specialists are required who can get quickly into the deeper mindset of each topic needed.

Dynavax managing director Dr. Eric Frings: "When it comes to GMP-compliant production, Detlef Behrens has so much experience and know-hows, that he was able to familarize himself with our structures in a very short period of time. That's a good things, because a deeper understanding of the interrelationsships is a basic requirement for anyone who takes responsibility. We have clearly benefited from his know-hows as well as from the employeeds of Behrens Projektmanagement GmbH not only in our investment projects for new process equipment, but furthermore at supporting engineering and quality management."

Who maintains a steady overview of things?

Efficiency in project management is a decisive success factor, especially in large companies where the most diverse projects and locations intertwine.

The explanation is easy to follow: In addition to their own projects, employees also have to keep an open eye on key interfaces in other areas and their related functions. In most scenarios, this cannot be achieved in a day-to-day business. Head of External Manufacturing Biotech, Dr. Karsten Kattmann: "I wanted to enhance the projects at Bayer Pharma with structure in order to optimize their efficiency. That's why I got the support of an experienced project manager, Detlef Behrens, who significantly improved the output, especially regarding to transparency, deeper planning structures, as well as identifying and avoiding risks. An employee from Behrens Projektmanagement regularly trained our employees on site from risk analysis up to effectively controlling a project, using our very own project examples which already existed in project structure planning. The benefit for Bayer Pharma is therefore the optimum."