Kemwell Biopharma Pvt. Ltd., a global biopharmaceutical contract development and manufacturing company, announced today that its oral solids manufacturing facility located in Bangalore, India has successfully completed its second U.S. Food and Drug Administration (FDA) inspection. This audit took place for an ANDA filed for a customer. On completion of the inspection, the FDA inspector concluded that the facility, systems and practices comply with FDA requirements and no observations were reported on Form 483. “Kemwell’s team is proud of the…
Author Archives: BPI Contributor
Three Steps to Start You on the Path to Obtaining the Best Recombinant CHO Cell Line
When developing efficient, high quality biomanufacturing processes, it is imperative that the expression system (‘host cell line’ and ‘vector’) and the process to isolate and identify the best clonal cell line (‘clonal cell line development process’) are of the highest quality. At FUJIFILM Diosynth Biotechnologies a team of scientists has invested more than 20 FTE years undertaking innovation work which has culminated in the development of a new host cell line and vector, along with an optimised clonal cell line…
Queen Mary University of London Wins 2014 Terumo BCT Plasma Exchange Innovation Award
Terumo BCT is pleased to announce that Queen Mary University of London (QMUL) has been named the recipient of the 2014 Plasma Exchange Innovation Award. The award is part of a program that supports one or more grants up to $100,000 to fund innovative science and research that will generate novel therapeutic plasma exchange practices. The lead investigator is Rino Cerio, BSc, MBBS, FRCP (Edin.), FRCP (Lon.) FRCPath. He is Professor of Dermatopathology and senior consultant dermatologist at QMUL and…
2015 Qosina Catalog with Thousands of Stock Components
The New 2015 Qosina Catalog offers easy browsing of thousands of stock components on a one-centimeter grid. Qosina has the largest selection of parts for the medical OEM, kit packer and pharmaceutical industries, offering free samples, low minimums, and Just-in-Time (JIT) delivery. The vast product range, along with complimentary samples, makes Qosina the first stop for all design engineers and purchasing agents who are sourcing components for current and future projects. Qosina offers high volume pricing discounts and supply chain…
The LSC-8000: A New Scintillation Counter
Zinsser Analytic released a new product – the LSC-8000. With advanced features, the LSC-8000 allows greater accuracy and faster measurements in liquid scintillation counting. As the system is small and compact, only a small space in the laboratory is required. The LSC-8000 has high resolution counting features thus providing reliability. Both ³H and 14C regions, which are common nuclides in liquid scintillation counting, are counted at an outstanding resolution of 0.05 keV/ch. Various sizes of sample vials are also supported.…
Computer-Aided Assay Development for Charge Heterogeneity Analysis by iCE
Unlike chemically synthesized drugs, protein therapeutics are a dynamic heterogeneous mix of active compounds. Due to their complexity, analytical techniques like isoelectric focusing have become indispensable tools in evaluating biologic preparations. The resulting surge in charge isoform analysis has led to major advances in instrumentation, such as Imaged Capillary Electrophoresis (iCEâ„¢)2 . However, to obtain the full benefit from improved instrumentation requires the coinciding development of robust assays. The goal of this note is to promote the successful application of…
Lonza Hosts First Global Endotoxin Testing Summit
Lonza will host the 1st Global Endotoxin Testing Summit, which will take place from June 1–3rd 2015 in Annapolis, MD and Pickering Beach, DE. The summit, hosted by one of the world’s leading suppliers of endotoxin detection products, will cover topics such as low endotoxin recovery, the use of alternative test methods that do not rely on horseshoe crab blood, and new options for process optimization. The Summit will feature a broad panel of internationally renowned speakers spanning industry, vendors…
GEA Niro Soavi Announces Pharma Skid Laboratory Homogenizers for Aseptic Production
GEA Niro Soavi, the leader in high pressure homogenization, offers highly customized Pharma Skid homogenizers, which are able to meet all the fundamental requirements of hygienic design and quality. The company’s experience in pharmaceutical, cosmetic, and chemical applications enables technical support in the preparation of a full documentation package for cGMP certification and in the selection of the right component materials (FDA approved gasket and 3A certified materials). The preparation of vaccines, therapeutics, diagnostics and enzymatic preparations require the breaking…
JSR Corporation and KBI Biopharma, Inc. Agree to Acquisition; INCJ and CMIC of Japan also participate
JSR Corporation (JSR), along with Tokyo-based CMIC Holdings Co. Ltd. (CMIC) and Innovation Network Corporation of Japan (INCJ), announced today that they have agreed to acquire KBI Biopharma, Inc., a biopharmaceutical contract development and manufacturing organization with facilities in Durham and Research Triangle Park, North Carolina and Boulder, Colorado. Following completion of the acquisition, JSR will own the majority interest in KBI within the acquiring group. With this acquisition, JSR continues to demonstrate its commitment to the life sciences industry,…
Use of ScreenExpert RoboColumns for High Throughput Study of Loading Conditions on HyperCelâ„¢ STAR AX and MEP HyperCel Sorbents for MAb Purification in Flow-Through Mode
The use of HyperCel STAR AX and MEP HyperCel sorbents for MAb polishing provides efficient contaminant removal. A study to screen loading conditions for MAb purification in flow-through mode on MEP HyperCel and HyperCel STAR AX sorbents was conducted using 200 μL ScreenExpert RoboColumns. The study demonstrates the suitability of ScreenExpert RoboColumns for scale down evaluation of chromatographic parameters, and the good consistency with data obtained on 1 mL PRC prepacked columns. ScreenExpert RoboColumns allow loading of high sample volume…