Background Hydrocyclones (HCs) have been recently extensively evaluated for their application in the separation of mammalian cells in perfusion bioreactors. The high centrifugal force derived within hydrocyclones is the key mechanism for cell separation inside such small-sized simple devices. This is usually accompanied by a very short residence time of the cells inside the separating equipment, usually not more than 0.2 s. Moreover, they have other specific characteristics, which highly recommend their application for the production of pharmaceutical products in perfusion cultivation bioreactors. They are characterized by their high performance, robustness, lack of movable parts, ease of in situ sterilization and suitability for cleaning-in-place processes.

Fusion proteins with a targeting function

作者: Schmidt, Stefan R.

A review.In this article the fusion proteins with a targeting organs and its functions, intracellular delivery, oral delivery are discussed.

Fusion proteins for half-life extension

作者: Schmidt, Stefan R.

A review.This article introduces the various fusion protein based concepts to modify the excretion of proteins in order to extend their plasma half-life.Half-life extension through size, recycling and increase of hydrodynamic radius was discussed.

项与 Rentschler Biotechnologie GmbH 相关的新闻（医药）

2023-09-13

·BioSpace

Rentschler Biopharma’s ATMP facility in Stevenage, UK, receives MHRA approval

UK site now set for clinical production of adeno-associated virus (AAV) vectors for gene therapy Highly experienced team ready to support ATMP innovators at all stages Offering comprehensive range of services from early process and analytical development through cGMP manufacturing for clinical trials STEVENAGE, United Kingdom and LAUPHEIM, Germany, Sept. 13, 2023 (GLOBE NEWSWIRE) -- Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), today announced that it has received the cGMP Manufacturing Compliance Certificate, following the successful inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) at its UK site. The ATMP business was announced in early 2021 and the facility is located in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage. Dr. Robert Panting, General Manager of Rentschler Biopharma’s ATMP business, said: “MHRA’s approval marks a major milestone for Rentschler Biopharma, and we are excited to offer our services from process and analytical development through cGMP manufacturing. Our team is highly knowledgeable, bringing years of experience in the field of AAV. We provide a tailored program for each client, in line with their needs and stage of development, while working closely with them to move projects forward as rapidly as possible. We are thus continuing the Rentschler tradition of offering a truly client-centric approach with the ultimate goal of helping patients. With our first clients already on board, we look forward to adding other exciting programs soon.” Dr. Christian Schetter, Chief Scientific Officer of Rentschler Biopharma, commented: “Our contribution to improving the health and quality of life of seriously ill patients is made possible by continuously expanding our expertise in the production of life-saving biopharmaceuticals. By launching Rentschler’s ATMP business, we aim to address an important gap in expertise and support for innovative, early-stage cell and gene therapy programs. It is gratifying to achieve this important milestone of MHRA approval, bringing us closer to reaching our objective of supporting clients already from the earliest stages of CMC development. We are continually looking to understand not only current client needs but future ones as well, which is how our ATMP offering came to fruition. We will continue to listen to our clients to anticipate how we can improve our offering and collaborate in advancing medicine to save lives, together.” Following the successful MHRA inspection, Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at their Stevenage facility in the UK. The company works to be a true partner to entrepreneurial players to enable them to transform their ideas into real products with the potential to treat and even cure patients with serious and life-threatening diseases. About Rentschler Biopharma SE Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, including adeno-associated virus (AAV) gene therapies, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,200 employees, headquartered in Laupheim, Germany, with a second site in Milford, MA, USA. Rentschler ATMP Ltd., located in Stevenage, UK, is dedicated to cell and gene therapies. For further information, please visit . Follow Rentschler Biopharma on LinkedIn and Facebook. Contact: Rentschler Biopharma SE Dr. Latika Bhonsle-Deeng Senior Director Corporate Communication Phone: +49-7392-701-874 communications@rentschler-biopharma.com Media inquiries: MC Services AG Eva Bauer Phone: +49-89-210228-0 rentschler@mc-services.eu U.S. Laurie Doyle Phone: +1-339-832-0752

基因疗法临床研究

2023-08-22

·EndPoints

UK invests $13M+ in 17 biopharma manufacturers

The UK is making a £13 million investment into 17 manufacturers dotted throughout the country. The companies do a range of work, including manufacturing nucleic acid-based medicines, automating or digitalizing manufacturing efforts, or developing methods around intracellular drug delivery for vaccines. The funds come from Innovate UK , a public entity supporting technology and science businesses. This includes contract manufacturer Rentschler Biopharma , which plans to implement analytical technologies to boost efficiency in the production of gene therapies. Rentschler recently built a cell and gene manufacturing site in Stevenage . You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

基因疗法

2023-08-22

·FiercePharma

UK pumps £13M into wide-ranging group of manufacturing projects

Among the 17 winners are companies such as Rentschler, Vitarka, Exactmer, VaxEquity and Sixfold. Improved vaccines, cutting-edge mRNA medicines and accelerated drug production are at the heart of a new funding project in the U.K., where 17 companies have been selected for government grants to explore better ways to produce pharmaceuticals. The companies are set to receive 13 million pounds sterling (about $16.6 million) from the Transformative Medicine Manufacturing program by Innovate UK, the U.K.’s innovation agency. The cash will be used to fuel a bevy of projects focused on nucleic acid medicines, intracellular drug delivery, digitalization and more. Among the 17 winners are companies such as Rentschler, Vitarka, Exactmer, VaxEquity and Sixfold. Rentschler, for example, will look to use "process analytical technologies to increase efficiency" in gene therapy production, according to a release from UK Research and Innovation. Vitarka, for its part, will focus on intracellular drug delivery using its experimental delivery technology EndoPore, which releases small interfering RNA drugs inside cancer cells. Vitarka will use the U.K. funding to develop an efficient EndoPore manufacturing process, according to the release. The U.K. has endorsed several manufacturing and vaccine projects in recent years. Back in March, the country’s National Health Service Blood and Transplant, which manages blood and platelet donations, opened a new clinical biotech center to help boost the U.K.’s capacity to make DNA plasmids and viral vectors. And in 2020, the U.K. started building the Medicines Manufacturing Innovation Centre to explore next-generation technologies to overhaul drug manufacturing.