Newsletter | August 13, 2019

08.13.19 -- 2019 U.S. State Policy Trends Impacting Pharma Manufacturers

Featured Editorial
2019 U.S. State Policy Trends Impacting Pharma Manufacturers
By Stephanie Hoops, Decision Resources Group (DRG)

If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.

Private Equity Accelerating Consolidation In The CDMO Market
By Bill Bolding and Ajeya Shekar, Provident Healthcare Partners

The CDMO industry has benefitted from Big Pharma’s divestment of in-house development and manufacturing capabilities in this current economic cycle. The rise of competition from new CDMO players and consolidation within the pharmaceutical sponsor space, however, has led to a crowded market and, in many cases, a commoditized service base.

Industry Insights
How To Design Cell-Based Potency Assays
Article | By Aryo Nikopour and Ming Li, Ph.D., Nitto Avecia Pharma Services

Not seen on HGTV: method design for cell assays. The many decisions when designing cell-based potency assays make home remodeling look easy.

Next-Gen Bioinformatics: The Expanding Role Of Deep-Learning Algorithms
Article | By Jen Brown, Thermo Fisher Scientific

Deep-learning algorithms have shown significant promise as applications in natural language understanding, decision making, and speech and image recognition. These algorithms are now being applied in bioinformatics applications within the biopharma industry to manage the increasing amounts of data from high-throughput techniques. Read more about recent applications of these algorithms to predict a variety of biological processes and interactions, particularly with respect to proteins.

Preparing For A Transition From Batch To Continuous Processing
Article | By Justin Kadis, Federal Equipment Company

Pharmaceutical companies and CDMOs embarking on continuous processing approaches who find themselves in the position of needing to procure a variety of new kinds of equipment with which they are largely unfamiliar can benefit from partnering with an equipment provider who possesses the necessary expertise and experience to support the critical decisions in this transition.

Answering Today’s Pharma Dilemma Of Build Or Buy
Article | By Charles Christy, Lonza Pharma & Biotech

A new business and operating model may address the build or buy dilemma, offering an innovative and agile way to manage demand uncertainty and reduce the risks associated with early investment decisions.

The Changing Landscape Of Wearable Drug Containment And Delivery
Article | By Graham Reynolds, West Pharmaceutical Services, Inc.

As innovations in medicine enable the introduction of new therapies for the treatment of chronic conditions impacting patients around the globe, safely containing and delivering these therapies is top of mind for both pharmaceutical companies and their manufacturing partners.

Improve Facility Monitoring Systems To Comply With Regulations
White Paper | By Tim Russell, TSI Incorporated

A facility monitoring system is a process monitoring tool that collects data from sensors, such as optical particle counters, differential pressure sensors, and temperature probes, in real time.

Smoke Signals: One Plant’s Secret For Assuring Aseptic Control
White Paper | By Tony Pavell, Fresenius Kabi

Airflow visualization testing, conducted as part of a routine review program, can help ensure that aseptic filling areas remain under a state of proper control.

Manufacturer Finds Solution For Transporting HPAPI Product With Containment
Case Study | By Jason Ott, Flow Sciences Inc.

A client was in need of a containment enclosure for an analytical weighing and solution-preparation operation involving highly potent active pharmaceutical ingredients (HPAPI) in powder form. Their goal was to transfer product from an enclosure to another enclosure. Read how flow sciences used a recently developed containment device and augmented it to fit the specific needs of the client.

Viral Clearance: The Basics On How To Conduct Effective Studies
White Paper | GE Healthcare Life Sciences

Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

Serialization And Aggregation Of Drug Products
Case Study | Wipotec-OCS

Pharma company finds a solution that allows the operator to conveniently assign the units from a lower packaging level to a higher level and, in this way, to set up the hierarchical relationships in the database.

  Clinical Trial Supply East Coast 2019

CTS East Coast 2019 will return to King of Prussia, where large and small pharma and biotechs will have the opportunity to discuss, debate, and consider new technologies and processes to streamline supply chain operations. With multiple solutions providers exhibiting their solutions and co-presenting, this meeting promises to showcase best practices and techniques that are translatable into practice.

5 Key Considerations When Expanding Single-Use Biomanufacturing Into New Locations
GE Healthcare Life Sciences
OptiForm Solution Suite
Detojet: Low-Foaming Liquid Detergent
Alconox, Inc.
Custom API Synthesis
Pfizer CentreOne Contract Manufacturing
Sartoclean CA Filter Cartridges
Sartorius Stedim Biotech
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