Tech transfer and programme management are our specialty. We can help with your most challenging projects.
Tech transfer and programme management are our specialty. We can help with your most challenging projects.
Offer support for the preparation of CMC-related documentation required for submission (US and Europe).
Skillshare
How the physical and chemical properties of a drug substance can be tuned and tailored to increase the chances of a successful bioequivalence study.
Identify the personal competencies that are vital for successful project management
A must-have competency for 21st century employees at all levels. Check the details
This course will focus on the challenges of generic solid dosage form development. More information here.
An intensive introduction to tabletting and associated processes. More details here.
Technology transfer and troubleshooting: the key determinants in the success of a project. Check details here.
Some Feedback
Site Director Haupt Pharma Latina
I have worked with Laura on important projects of product supply. The way she managed the CMO/Client relationship has been outstanding and impressive in terms of trust and willingness to finalize always win-win solutions.
Aenova Group
Senior Vice President (Generics, Specialty and Biosimilars)
Your contribution was tremendous in the past. We now continue to progress.
Lupin Pharmaceuticals
Scientific Director, Head of Technical Integrators
Thank you Laura, reflecting on the last 2+ years, you really applied the powers of Proteus to Janssen Vaccines. In a way, the AdVac platform is like the Protea flower; present in variety of shapes, sizes, hues and textures, where you operated with grace and beauty within a diverse team with various backgrounds. You end now your stay with contributions to two approved vaccines, Ebola and Covid, also embodied within the name “Laura”, as the symbol of victory, honor and fame. Wish you all the best with your next projects, and already am looking forward to our future collaborations.
The Janssen Pharmaceutical Company of Johnson & Johnson
Senior Life Science Consultant
With you as a lead, the team will always be an ACTUAL TEAM!
Avertim
Product Technology and Transfer Manager
The trainer's expertise and preparation were great. The questions from the participants and the answers/discussions from the trainer were very helpful
Zentiva
Drug Product Subject Matter Expert
The trainer was very knowledgeable about the topics and was able to answer all questions.
Pfizer
Feel free to contact us to find out what Protea can mean for you.
Our latest blog posts
Lately I hear more and more people complaining about the burden of meetings and actually stating that meetings are the no.1 barrier to productivity.
Even worse a lot of people claim to leave a meeting without a clear idea on what to do next. The result? More follow up meetings… Adding to the frustration, many meetings are simply used to disseminate information (couldn’t it have been an email?). As a consequence, we are ending up hating them so much that they are ineffective even for social aims, like collaborating with colleagues, brain storming or decision making.
How to solve this? There are serious studies on the topic as well as more humorous ones. The reality of organizational life in contemporary organizations involves many contradictions and the meeting load paradox is one of them. People need meetings. Teams need meetings. However, there are costs associated with having more or fewer meetings. It is these costs that organizations, their leaders, and their employees need to consider. At what point does the meeting load become a burden to employees and managers rather than lift them to better heights?
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing.
As the biopharmaceutical market continues to expand and reliance of SU manufacturing rises, demand for SU consumables (i.e. bags, containers, filters etc) is also increasing. A key driver for that growth is the fact that SU consumables come pre-sterilized and ready-to-use, making step and changeover from one product to another much quicker and easier. Single-use systems enhance flexibility, scalability and efficiency. Single-use facilities boast the benefits of shorter facility development and deployment timeframes.
However stainless steel is expected to remain in use for some time. Stainless steel retains its relevance for certain products. Universal block-buster, such as treatments for cancer, diabetes and others in which large volume is required, will keep on being produced in stainless steel. Stainless steel bioreactors can support manufacturers across a variety of higher volumes, including those between 10.000 and 20.000 L. Though stainless steel has a higher upfront costs, if you have a blockbuster drug, it could provide more long terms savings because of its durability.
Is there a best choice then? Choice is totally dependent on each biomanufacturer’s unique scenario. Factors to consider can include molecule type, cell density, demand stage (pre-clinical, early phase, late-phase, clinical, commercial etc), patient population, quantity of product,, single-product versus multi-product facility and new versus existing facility. All these together (and more) will help make a best choice from both an economical and environmental perspective.
In conclusion, a comprehensive evaluation always has to be made at design onset.