Newsletter | February 18, 2020

02.18.20 -- The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter

Featured Editorial
The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter
By Barbara Unger, Unger Consulting Inc.

This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product issued during inspections in 2018 and published in October 2019. Part 1 provided an overview of the 2018 data and identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.

Choosing A CDMO: If You Can’t Answer “Yes” To These Three Questions, Walk Away
By Kevin Wall, principal consultant and owner, Cincero Consulting

Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.

Industry Insights
Seven Trends Impacting Chemical Process Development
Article | By Justin Kadis, Federal Equipment Company

Using new approaches to process development and associated equipment, engineering, and business models to increase efficiency and reduce costs.

An Automated, Quantitative Method For Stability Evaluations Of Pharmaceutical Emulsions And Solutions
Article | By Justin Hardwick, Micromeritics Instrument Corporation

Manufacturers must make the move from relying on qualitative, user-dependent results to implementing a fully traceable, analytical, and quantitative method now available in today’s market.

Industry Trends In Biologic Formulations
Article | By Victoria Morgan, West Pharmaceutical Services, Inc.

The scale-up of biopharmaceutical production has seen a radical shift away from large-scale, stainless-steel production equipment to single-use, disposable technologies and components, such as bags and bioreactors, which drives to higher quality, faster delivery, and lower cost production.

Cell Therapy Manufacturing: The Supply Chain Challenge
Article | By Christina Bennett, GE Healthcare Life Sciences

Overcoming the challenges of manufacturing and administering a complex product to any patient is critical for delivering cell therapies. Two industry experts detail strategies to meet supply chain challenges.

How To Maximize The Performance And Life Of Your Centrifuge
Article | By Matt Squire and Ryan Rostkowski, NuAire, Inc.

Centrifuge technology has evolved, and while advanced features offer improved functionality, proper use and care on a daily basis are critical. It maximizes performance and extends the equipment life.

Overcoming Bioavailability Challenges In Oral Formulation Development
White Paper | By Sundeep Sethia, Ph.D., Pharmaceutics International

With nearly 90 percent of developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must address this obstacle by applying approaches to improve an API’s pharmacokinetics.

Application-Specific Enhancements To Thermo Scientific HyPerforma Single-Use Bioreactor (SUB)
Poster | By Ben Madsen, Tony Hsiao, Paula N. Decaria, Jordan Cobia, Mason Smith, and Nephi Jones, Thermo Fisher Scientific

The rapid growth of biotherapeutic manufacturing has created significant demand for workflow solutions featuring greater product yield, lower production costs, and accelerated development timelines. To address these demands, developers are increasingly focused on solutions that address the specific needs of diverse bioproduction processes.

The Future Of Shipping In Modern Medicine: Reusable vs. Single-Use Shippers
White Paper | Pelican BioThermal

A shipping solution that maintains the temperature of a product in its journey to the patient, preserves the intent of the medication, the safety of the investment, and the lives of the patients who depend on them.

When Clean Is Critical: Understanding Parameters And Definitions Of Clean
White Paper | Thermo Fisher Scientific

Cleanroom environments necessitate high-quality materials and equipment that conforms to a variety of specified standards. This white paper explains how clean parameters are defined and validated.

Selecting A CMO: Top Considerations
Article | AbbVie

Choosing the right contract organization to handle the development and manufacturing of a drug product is of critical importance. Here are tips to ensure a successful outcome.

Clinical Supply Optimization: Enhanced Service Model Saves Client Time On Supplies
Case Study | Thermo Fisher Scientific

The VP of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Clinical supply optimization, designed to handle supply forecasting, demand planning, and other high-level supply chain management functions, appeared to fit the company’s immediate need.

Accessible Anywhere: How Pfizer Deployed The PI System To Enable Production Analysis Across The Organization
Case Study | OSIsoft

Using OSIsoft’s PI System, Pfizer embarked on a journey to digitize the drug discovery process and create a single source of truth for self-service operational insights that are accessible anytime and anywhere.

Collegium Pharmaceutical’s Innovative Approach To Abuse Deterrence
Case Study | Thermo Fisher Scientific

To address the ongoing public health crisis related to opioid abuse, Xtampza ER has been developed to resist the ability of abusers to tamper with the product and alter the route of administration.

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