Manufacturing

A Strategy to Remove Formulation Development from the Critical Path During Biologics Development

Biopharmaceuticals tend to be highly unstable. Therefore, as the product development program progresses to phase 3 clinical stage, formulation development is required to ensure drug product quality and stability during manufacturing, storage and clinical administration. Also, formulation development is often on the critical path to successful IND and BLA fillings. During this Q&A, Dr. Jun Lu, Director, Analytical Development, discusses how Catalent Biologics utilizes automation, specifically the Uncle platform, during formulation development. Login and click View PDF to view the…

High-Viscosity Mixing: Choosing the Right System for the Job

Manufacturers of topical ointments, gels and lotions for BioPharma, personal care and other high-viscosity products face critical product quality challenges in their mixing processes. The better these challenges are understood, the more specific the design and configuration of processing equipment can be, to optimize product quality and maximize plant productivity. Unfortunately, conventional mixing systems may limit the ability of product manufacturers to optimize productivity and efficiency. The inefficiency of conventional dual-agitated vessels, multiple mixing vessels, and the operational complexity of…

Understanding Critical Measurement Parameters in Vaporized Hydrogen Peroxide Bio-decontamination

Effective destruction of microorganisms can be achieved with vaporized hydrogen peroxide, a safe and effective bio-decontamination method in many applications, including medical device manufacturing and healthcare procedure room decontamination. However, to ensure efficacy, it is necessary to monitor the level of hydrogen peroxide during the bio-decontamination. Measurement parameters are interdependent; temperature affects humidity, as does H2O2 concentration. These in turn will determine the point in time that condensation will occur, a critical phase. Some manufacturers of bio-decontamination chambers or isolators…

Flow Cytometry News: Does your lab comply with 21 CFR Part 11?

21 CFR Part 11 refers to the section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Chapter 21 covers all regulations pertaining to GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice), relating to the pharmaceutical and healthcare industries. Part 11 covers all FDA regulated issues pertaining to electronic records and electronic signatures. All computer systems that store…

The DeltaV™ PK Controller: Powerful Standalone — Easily Integrated

The PK Controller brings ground-breaking innovation and technology that is powerful standalone for small units and easily integrates into a plant-wide DCS. With faster logic execution, built-in native Ethernet ports and native device protocols, the DeltaV™ PK Controller addresses a wide variety of applications and system sizes. The fit-for-purpose controller enables you to have a single native database and system allowing you to shorten project schedule and accommodate late changes. What is Powerful Standalone? Operate and configure your standalone applications…

RFID is the New Weapon in the Fight Against Counterfeiting

Counterfeit goods cost the economy up to $250 billion a year, with U.S. Customs and Border Protection agents seizing nearly $80 million in counterfeit pharmaceuticals and personal care products in one year alone. The World Health Organization (WHO) reports that 200,000 people die each year due to ineffective and substandard (counterfeit) malaria drugs. The WHO also reports similar issues in the medical device market. In 2010, over 8% of devices in circulation were counterfeit and that number increased by 50%…

Scale-Out Biomanufacturing – A Paradigm Change to Scale-Up

In biomanufacturing, a production scale change is required to either meet the market growth demand or when a product moves from clinical to commercial manufacturing. How that volume is increased depends on whether a scale up or scale out philosophy is used. The industry standard has been to scale up, which translates to increasing the size of the bioreactors used in manufacturing runs. However, due to the recent availability and ease of single-use technologies, coupled with improvements in cell culture…

Digitization of Biology to Revolutionize Lab Productivity

Biological research is limited by a technical barrier that exists between scientists and lab hardware. Each piece of hardware has its own software, its own file format and its own eccentricities, which the user needs intimate familiarity with to get the most from the machine. Using Antha, a user-friendly but hugely powerful software platform, gives biologists sophisticated, flexible and integrated control over lab hardware. This enables experiments and lab workflows to be rapidly automated, with data automatically integrated and linked…

Fast Trak Education and Training 2017

Gain specialist knowledge in bioprocessing With our Fast Trak education, you can access application training in specialized bioprocessing techniques. The courses provide a tangible learning experience for process development and manufacturing scientists, relevant to everyday work. Comprehensive training for your specific needs The Fast Trak courses cover various topics from upstream to downstream. These include cell culture, bioreactor scale-up, column packing, basic chromatography, as well as optimization and scale-up for both pilot and manufacturing scales. In addition to our standard…

Antibody Targeted Therapy Online Course

This online module focuses on an intensive overview of the antibody therapeutics field, enabling you to: Gain a comprehensive understanding of the antibody field and awareness of the historical aspects, current research and future direction of the development of antibodies as therapeutics. Provide an overview of the antibody fields ranging from structure and function, through to the recent development of antibodies as therapeutics including manufacture and clinical development. Gain insights to some of the issues that are required to develop…