Selexys Pharmaceuticals, Corp., announced today that it has successfully completed a $23 million Series A equity financing, led by MPM Capital. Additionally, Selexys entered into an agreement with Novartis Pharmaceuticals whereby Novartis has been granted an exclusive option to acquire Selexys and its lead asset, the anti-P-selectin antibody SelG1, following the successful completion of a Phase 2 clinical study in patients with sickle cell disease.
While autologous cell therapies offer promise in the way of patient treatment, manufacturing them is a complex process requiring thorough understanding of the cell type(s) that a company will be providing as therapy. When it comes to ensuring the successful manufacturing of a cell therapy drug, Ross Tubo, chief scientific officer at Vericel Corporation, says there are three critical areas where particular attention should be paid.
When Parrish Galliher first founded Xcellerex, now part of GE Healthcare, he referred to the business idea as “bugs on wheels” because unlike traditional stainless steel biologic manufacturing facilities which can’t be built quickly, easily changed or moved, his concept for the FlexFactory allowed manufacturers to build and/or modify manufacturing capacity quickly and at far less cost. Moreover, no longer did companies have to take three to four years to build a plant that could manufacture only one product, but could build structures that could be changed quickly from manufacturing one product to another. The idea was, at the time, quite disruptive to our conservative industry where, according to Galliher, it can take close to a decade for companies to adopt new technology. Galliher confided that in the early days of starting Xcellerex in December 2002, he struggled to get funding for the business.
Without single-use standardization, the customization required to build a single-use facility may prevent a full-scale adoption of single-use technology. So how do we move forward? Maybe, by taking a look back.
The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company
Because single use bioreactors offered by manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.
In the last three decades Ozone has become a very important and efficient tool to achieve high quality pharmaceutical grade water. This paper will address two main topics that are critical for the effective use of ozone within the water processes of the life science industry. By Georges Schmidt, Hach Lange Sàrl, Geneva, Switzerland
Following the launch of the EX-CELL CD Hydrolysate Fusion, SAFC conducted a study with partner company Sartorius Stedim Biotech. EX-CELL CD Hydrolysate Fusion is the first fully chemically defined media supplement of its kind in the industry. By SAFC
Most pH adjustment process steps in single-use biomanufacturing require manual manipulation of the product and vessel, including off-line sampling, pH measurement, and the addition of acid and base.
Bio-Simplex™ Sterile Disposable Centrifuge Tubes are ready-to-use cost-effective single-use containers designed for general biopharmaceutical manufacturing applications such as preculture and sampling.
A wide selection of ion exchange resin is available in various particle sizes, ionic forms, and purity ranges to offer a variety of purification solutions for process applications. Nuvia ion exchange resins are a family of best-in-class ion exchangers built with exceptionally high capacities and excellent purification capabilities, providing process developers more flexibility and higher productivity. The Macro-Prep are rigid macroporous hydrophilic resin meet the demands of process-scale applications. Chemically and mechanically stable, the resin operate well at low and medium pressures.
Compact, lightweight and easy to install, the Parsum IPP-70-S probe delivers in situ, real-time size and velocity measurements for solid particles up to 6000 µm in size. The IPP 70 continuously tracks a large variety of PSD parameters making it ideal for endpoint detection, process control, process optimization and real time quality control for a range of applications.
Capto S, Capto Q and Capto DEAE are, respectively, strong cation, strong anion and weak anion exchange media for packed bed chromatography that increase speed and throughput in capture and intermediate purification.
PreDictor RoboColumn units are mini columns prepacked with GE Healthcare BioProcess chromatography media. When used together with a robotoic system such as Tecan, PreDictor RoboColumn units perform automated parallel screening of media and process conditions with minimal sample consumption.
The CelliGen 510 is a compact sterilizable-in-place cell culture system ideal for pilot to small scale production processes. The modular design features a wide variety of standard options allowing this system to be flexible enough to meet most process requirements.
Meissner has developed a line of accessories to complement our One-Touch® single-use systems portfolio called FlexCessories™. The products in this portfolio are designed to facilitate the secure deployment and streamlined implementation of single-use systems.
America's biopharmaceutical companies are using biological processes to develop 907 medicines and vaccines targeting more than 100 diseases, according to a new report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA).
Research peptides are used around the world for a number of reason but most notably to test the effects of growth hormone related hormones and growth hormone related peptides and their effects.
Amgen (NASDAQ: AMGN) today outlined the company's long-term strategy during a Business Review meeting with analysts and investors inNew York City.
Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today provided an overview on the early breast cancer competitive status of the lead cancer immunotherapy product, AE37, under development at its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM (NYSE, Euronext: DSM KON), announced today that it has signed a non-exclusive license agreement with Amgen Inc. for access to DSM's proprietary XD® high cell density process patents.
BioInvent International AB recently announced that Svein Mathisen has resigned from his positions as chief executive officer of the Company and as member of the Board of Directors.
Glen Allen, VA /PRNewswire/ - Star Scientific, Inc. (NASDAQ: STSI) announced today the preliminary results of the Company's ASAP (Anatabloc Supplementation Autoimmune Prevention) Human Thyroid Study that analyzes the impact of anatabine dietary supplementation on thyroid health.
Gradalis, Inc. today announced that is has closed a $24 million Series B round of financing. Gradalis will use the funding to advance its autologous vaccine platform, FANG™, through late-stage clinical trials and expand manufacturing capabilities to accommodate commercial launch of FANG.
ArmaGen Technologies, Inc., a leader in the delivery of biotherapeutics targeting the central nervous system (CNS), today announced James Callaway , Ph.D. as Chief Executive Office and member of the Board of Directors.
