Process and Scaling

Could flexible manufacturing change the standards for biopharmaceutical production? To find out, Equipment and Processing Report talked to James Robinson, vice-president of technical and quality operations at biotechnology company Novavax (Rockville, MD).

The authors sought to improve the productivity of protein synthesis by using a highly active cell-free extract from Escherichia coli and by optimizing buffer conditions and shaking conditions.

Directors and staff miss the mark when it comes to following procedures.

Blame it on cafeteria gossip, outdated procedures, and major miscommunication.

Recent advances in microreactor technology are improving the application and scale at which the technology can be applied.

New tests solve one issue, but cheaper plastic and new stoppers cause problems.

The manufacturing process, which influences a drug's safety and efficacy, is particularly critical for drugs administered through injection, and personnel must closely supervise lyophilization to ensure product quality.

Reading PharmTech's October article on Critical Challenges to Implementing QbD gave me the impression that we might have the road map to Moksha or Nirvana. Unfortunately that was not meant to be.

The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.

Like life, the workplace also can have many surprises.

Representatives of one pilot program participant, Wyeth, outline the experiences and lessons learned for implementing a science- and risk-based approach to drug-development and manufacturing.

The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.

Officials from the US Food and Drug Administration discuss best practices for applying quality-by-design concepts. This article contains bonus online-exclusive material.

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.

The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

Thanks to their keen observations, these auditors reveal the true culprits of deviations.

The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help pharmaceutical companies achieve consistently high product quality.

Uncovering the root cause of contamination and leveraging the collaborative learning loop of QbD -Aegis Whitepaper

An ounce of contamination usually leads to a mountain of investigation.

Some GMP agents seem to find a way to squander time, money, and common sense.

Short-term problems in software or hardware lead to long-term manufacturing troubles.

In 2005, a small delegation (myself included) of the European Fine Chemicals Group (EFCG) met with the deputy head of the cabinet of Commissioner Kyprianou (the then Commissioner responsible for health and consumer protection). Our mission was simple - we were there to raise a red flag.

Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year - in other words, one pack in every 20000 is counterfeit.

Process steps, GMP documents, a purification vessel, and validation seem to disappear.

With a new head of the FDA expected to be announced imminently, the pharmaceutical industry waits to witness the changes that will inevitably accompany the new appointment. These changes could, however, also impact the rest of the world's pharmaceutical markets.

The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.

GMP agents report on old products, aseptic violations, and unexpected emotions.

Operational excellence awaits, but only if you can implement PAT successfully.

The source of a problem reveals itself after some investigation, or it may crash down on you.

When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.