Newsletter | September 10, 2019

09.10.19 -- FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018

  The CMC Function: Best Practices And Optimization

ISR interviewed 15 CMC professionals at 14 Top 50 pharmaceutical and biotechnology companies, as well as one company outside the Top 50 to better understand the CMC (chemistry, manufacturing, and controls) function throughout the preclinical, clinical, and commercialization phases of the product development process. This report details how CMC departments are modeled, challenges faced by CMC professionals, and best practices and forward-thinking perspectives about how the role may evolve over time. More.

Featured Editorial
FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
By Jerry Chapman

In this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. Part 1 unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.

Cell And Gene Therapies: Do Biopharma Manufacturing And Development Methods Apply?
By Mark F. Witcher, Ph.D.

Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of cellular and gene therapies?

Industry Insights
Intensified Chromatography Strategies
Article | By Josefin Bolik and Oliver Hardick, GE Healthcare Life Sciences

With a newer toolbox of options to intensify downstream manufacturing operations, it is important to understand what factors should impact decisions regarding the implementation of these solutions.

Single-Use Equipment: Disruptive Innovation
Article | By Mona Akerholm-Kaapro, Elomatic

The availability of single-use equipment and components is growing rapidly and has forced unit prices down. In addition, the usability and reliability of these systems has increased markedly.

Pharmaceutical Cold Chain Expertise: A Missing CMDO Ingredient?
Article | By James Klingelhoefer, Pelican BioThermal

What if CMOs/CMDOs could offer a true end-to-end solution by ensuring strict temperature control of their products in transit? What impact would these solutions have on pharma customers?

Track-And-Trace In The Drug Supply Chain
Article | By Lloyd Mager, AbbVie

Though the timelines may vary, across the globe more and more countries are requiring product identifiers and serialization of prescription drugs — right down to individual salable units. 

Investment Recovery For Pharma Equipment
Article | By Matt Hicks, Federal Equipment Company

This article is the second of a two-part article discussing the unique value proposition of used pharmaceutical manufacturing equipment.

Critical Considerations When Selecting A Vented Balance Enclosure
White Paper | By Robert K. Haugen, Ph.D., Steve Janz, and Ray Ryan, Flow Sciences Inc.

This paper discusses the primary benefits of the vented balance enclosure, which is critical to the safe and effective weighing of potent powder compounds, APIs, and nanomaterials. 

Applying Quality Systems Approach To Improve Supply Chain Management
Article | B. Braun OEM Division

This article presents a quality systems technique that is ideal for improving trust between a manufacturer and a supplier, as well as improving the overall quality of medical devices.

Direct Heat Versus Water Jacket CO2 Incubators
Article | NuAire, Inc.

CO2 incubators enable the necessary environmental control and isolate cell cultures from external conditions and contamination. Which one is the best fit for your research?

Are The Components In Your Prefilled Syringes Compatible?
Article | Parenteral Drug Association (PDA)

While a prefilled syringe offers many advantages for biologic products, manufacturers must evaluate the potential impact of a prefilled syringe on product quality prior to selecting the final components.

Metal Detection System Improves Efficiency And Product Safety
White Paper | Thermo Scientific Product Inspection

The AuditCheck metal detection verification performance system utilizes an automated test shuttle that moves through the metal detector’s field at user-specified points in time.

Dual-Lane Checkweigher Meets Pharma Manufacturer Automation Needs
Case Study | Mettler-Toledo Product Inspection

A checkweigher helps this pharma manufacturer detect and reject under- and over-filled tubes to ensure final product quality and provides data to improve yields.

Meeting Patient Needs Through Expedited Delivery Of Phase I Materials
Case Study | Thermo Fisher Scientific

To quickly deliver their product to patients in need, Reneo Pharma teamed up with Thermo Fisher Scientific to take advantage of its Quick to Clinic for Oral Solid Dose program.

GE Healthcare Life Sciences Webinar: Smarter Development Of Chromatography Processes

September 24, 2019 | 11:00 AM EDT

Smart process development is a collection of approaches to make process development better and faster — providing the developers with tools to face the rapidly changing landscape. This webinar will review three fields that enable reduced timelines and improved outcomes of process development activities:

  • In-silico process development and data-driven decisions
  • Management of process variability through deeper process understanding
  • Use of high-throughput methodologies
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