With the marketing authorisation of the first pharmaceutical product produced by gene technology in the 80s, a new era of biopharmaceutical and biotechnological development and manufacturing started. By 2007, already 20% of all newly released pharmaceuticals were biopharmaceuticals.
Future pharmaceutical products based on biotechnology and the biosimilars (biogenerics) will become more and more important and represent a higher share of pharmaceutical products.
But the way from product development to manufacturing of biopharmaceuticals, biosimilars and biologics is complex, time-consuming, risky and cost-intensive. The pharmaceutical industry’s strategy to retreat operationally from this market segment should encourage small and mid-sized biopharmaceutical companies to look for convincing and profitable product candidates.
Furthermore, this development provides contract manufacturers with good prospects for developing and manufacturing biological products. The time aspect should not be underestimated – 8-12 years from the beginning to product launch is a general rule.
What are the possibilities to speed up and optimise the process of development to manufacturing? Do modern methods in analysis and microbiology provide the chance to save time and costs? Further, are QbD and Process Validation benefits or constraints?
During the two day conference ‘Vaccines and Biologics’ in Dessau-Roßlau, near Leipzig, Germany, from 22-23 November, you will become acquainted with examples and strategies to develop, transfer and manufacture vaccines and biologics. Experts from authorities and industry will give you an insight view in their experience with:
- Regulatory Requirements
- Inspection and Findings
- Challenges in Development of Biologics
- Disposable Manufacturing Processes
- Optimising of Development Processes
Special site visit
A special visit to IDT Biologika’s manufacturing site on the occasion of its 90th anniversary will close the gap between theoretical background and practical implementation.
Biopharmaceutical companies and vaccine manufacturers
This conference addresses responsible authorities and associates of biopharmaceutical companies and vaccine manufacturers who are involved in product development, process development, scale up and manufacturing of biologics as well as in analytical contract laboratories.
The European Compliance Academy (ECA)
The ECA is the leading independent European membership organisation with regard to pharmaceutical Quality Assurance and GMP compliance. It has almost 4,000 members in more than 60 countries.
Register and save €100
The ECA offers a preferential rate to Cleanroom Technology readers and visitors. Register at www.vaccines-conference.org with the code ct2011 and you will receive a €100 rebate on the registration fee. Please make sure to mention the code in the comment field.
