Bioprocess International

Bioprocess International
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Bioprocess International

 •  January 9

AGC Biologics, a convergence of Asahi Glass Company (AGC) Bioscience, Biomeva GmbH, and CMC Biologics, announced today that effective January 8, 2018, the company will be integrated and newly branded as AGC Biologics. AGC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, will offer the highest level of...

Bioprocess International

 •  January 4

Abzena plc, the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, has selected Sartorius Stedim Biotech as its preferred equipment supplier in the U.S. Abzena has selected Sartorius Stedim to equip its integrated CDMO facilities in Bristol, PA (development and GMP...

Bioprocess International

 •  December 29, 2017

One of the key elements of any biopharmaceutical drug development project is the timeline from identification of the appropriate DNA sequence to investigational new drug (IND) application filing and the start of clinical trials. Typically, this timeline ranges from 18 to 20 months, depending on the type of molecule being developed and the extent...

Bioprocess International

 •  December 21, 2017

Innovation is at the core of all pharmaceutical, biopharm and bioprocess applications. With extensive experience in the biopharmaceutical industry — and particular expertise in single-use bio-pharmaceutical equipment — PendoTECH delivers a line of pressure sensors, control systems and software for measuring, monitoring and data collection in...

Bioprocess International

 •  December 19, 2017

FUJIFILM Diosynth Biotechnology (FDB) is a multifunctional commercial development manufacturing organization (CDMO) that manufactures virus-based therapeutics. Its site in Texas specializes in both adherent and suspension cell culture for production of virus vectors and for development of analytical assays to support production and expression of...

Bioprocess International

 •  December 19, 2017

New sterile molded filling assemblies from AdvantaPure continue the shift to single-use processing methods that save time, reduce cross contamination risks and increase productivity between batches of biopharmaceutical and pharmaceutical products. “These assemblies were developed specifically for vial and syringe filling,” notes Lawrence Morano,...

Bioprocess International

 •  December 19, 2017

Short time frames are a major challenge in developing alternative microbiological methods for autologous cell therapy products. Ideally, results are made available in under a day. Obtaining regulatory acceptance also can be a challenge, but it is made easier if methods are included in an application (e.g., a biologics license application, BLA)...

Bioprocess International

 •  December 13, 2017

Preparation and storage of buffers is a challenge for biopharmaceutical companies developing protein-based pharmaceuticals. The need for volumes of buffer to purify increasing upstream titers have become a major bottleneck in biopharmaceutical downstream processing. Italian biopharmaceutical company Kedrion Biopharma collects and fractionates blood...

Bioprocess International

 •  December 13, 2017

Single-use technologies offer significant advantages over traditional stainless-steel solutions for biopharmaceutical manufacturing. Reductions in setup times, cleaning and cleaning-validation costs, elimination of cross-contamination risks, and smaller footprints are just some of the benefits they provide. Although adoption of single-use systems...

Bioprocess International

 •  December 11, 2017

Single-use technologies are now dominant for the clinical production of biopharmaceuticals and are becoming more mainstream within commercial manufacturing facilities. They allow biologics manufacturers to decrease the footprint of their facilities by approximately 20% because of a reduced need for utilities that generate water, steam, and...