Biologics APIs

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

CMC Biologics and OnoSynergy form an agreement from cell-line development.

BioWa and Lonza have entered into a licensing agreement with MedImmune for cell line technology.

Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

Pfizer advances its pipeline of antibody-based therapies using a host cell line that combines engineered glycosylation technology and enhanced gene-expression.

FDA updates guidance to reflect advances in technology.

Facility will use mammalian cell-culture technology and be ready for operations by 2016.

Applications of ZFN technology in biopharmaceutical cell-line engineering.

Because peptoids are relatively easy to synthesize, have tremendous sequence diversity, and are more proteolytically stable than peptides and proteins, they have significant potential for use as APIs, drug-delivery agents, and in numerous biomedical applications.

Shimadzu's LCMS-8040 combines newly improved ion optics and collision cell technology with proprietary ultrafast technologies.

A Q&A with Tony Hitchcock, head of manufacturing at Cobra Biologics.

Roche and BioLamina have entered into a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research. The collaboration will assess laminin-based in-vitro cell culture matrices that can offer physiological microenvironments for living cells.

Growth is seen in outsourcing of insect- and plant-cell-based bioproduction expression systems.

As 2012 comes to a close, Pfizer leads among Big Pharma companies for FDA approvals of new molecular entities and biologics.

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

Boehringer Ingelheim has entered into a non-exclusive technology and commercial license option agreement with BaroFold. Under the terms of the agreement, Boehringer Ingelheim will license BaroFold's pressure-enabled manufacturing technology (PreEMT).

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2012 edition from EMD Millipore and Meissner Filtration Products.

Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.

Industry wants more innovation, but can suppliers meet customer needs?

In this technical forum, experts describe different methods of rapid microbial testing and their applications.

On Mar. 7, 2012, GE Healthcare announced an agreement to acquire Xcellerex, a supplier of manufacturing technologies for the biopharmaceutical industry, for an undisclosed amount.

Debottlenecking downstream mAb purification.

Combining olfactometry analysis with multidimensional gas chromatography–mass spectrometry provides an extremely useful analytical method for identifying aroma or odor notes from a sample.

A Technical Forum Moderated by Patricia Van Arnum, featuring contributions from PerkinElmer, BioTools, Chiral Technologies, Shimadzu Scientific Instruments, GE Analytical Instruments, and Waters.

The authors investigate the effect of low pH and ionic strength on aggregation using turbidity measurements and size-exclusion–high-performance liquid chromatography.

Could oral absorption-enhancing technologies change the shape of protein delivery?

New product reviews for October 2011 focusing on analytical instrumentation.

The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.