Facilities must demonstrate that a disinfection procedure efficiently reduces micro-organisms in a pharmaceutical cleanroom environment. Different guidelines emphasize the importance of validation studies for proper disinfection and several test methods allow for anti-microbial effectiveness testing.

	This article describes how a disinfection validation study must be defined according to the specific conditions at the site and the variables within each method such as the type of disinfectant product, contact time, interaction with special surface materials, and special species of resident micro-organisms.

	The role of the testing laboratory and the specialization of testing personnel will also be discussed, to ensure accurate, reproducible data is produced from anti-microbial effectiveness testing.

Articles

Features

Effective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.


Clean, Disinfect, and Validate

The PNSU, probability of a non-sterile unit, is crucial to determining process conditions.  However, the concept is often misapplied. 

	Sterile processing expert Jim Agalloco explains how the proper application of a biological indicator can guide the development of an effective sterilization process.
	 

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

Kill the Bioburden, Not the Biological Indicator

Kirk Randall of Cryoport shares insights into the complexity of cold chain logistics for advanced therapeutics (e.g. cell and gene therapies), and what is needed to ensure that logistics does not impede clinical trial or commercial success. Included are discussions of skill sets to look for in contract partners.

The complex packaging and logistics required for personalized medicine pose significant challenges, but proactive planning can help ensure success.


Cold Chain Logistics for Personalized Medicine: Dealing With Complexity

Contamination with microbes, mycoplasma, viruses, and adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can occur from many sources, raw materials are the most significant source of contamination. 

	Strategies for preventing contamination including upfront testing of materials, barrier disinfection methods, and adhering to best practices in processing and sanitation are explored.

	Avoidance of animal-based raw materials, as well as careful sourcing of any materials used, are discussed.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

Ensuring the Biological Integrity of Raw Materials

Biopharmaceutical experts Stephen Perry, CEO of Kymanox, James Blackwell, principal consultant with The Windshire Group, and consultant Mike Ultee, share best practices and musts to avoid in biopharmaceutical technology transfer. 

	Some crucial takeaways?  Share all data (especially data on failed runs in the past), and include clear instructions for sampling.  In addition, aim for reproducibility.

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.

Getting Biopharmaceutical Tech Transfer Right the First Time

As global demand for injectable systems grows, so too does the demand for innovative delivery options beyond the traditional system of syringe and vial. For lyophilized forms, dual-chamber systems offer advantages.

	When considering whether to use a dual-chamber system, it is important to understand the necessary development process.

Prefilled dual-chamber cartridges offer several advantages. Several steps should be taken to determine if a dual-chamber system is viable for a lyophilized injectable drug product.

Developing an Injectable Compound for a Dual- Chamber Delivery System

GlaxoSmithKline (GSK)’s R&D Biopharmaceutical Pilot Plant in Upper Merion, PA is a R&D clinical trial material (CTM) manufacturing facility with an aggressive processing schedule that requires minimal shutdown interruptions. Utility reliability is paramount to achieve production demands and regulatory quality requirements.

	To meet the utility demands for increased CTM output, a capital investment project was required to replace the existing, obsolete high purity water (HPW) generation system and water-for-injection (WFI) generation system with new, reliable technology.

	This article describes how the new systems were designed and installed in a challenging space to ensure redundancy and improve sustainability.

The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.

Case Study: Retrofitting Two New High-Purity Water Systems

Dramatic increases in protein titers from cell culture processes have enabled downsizing of upstream bioprocesses and facilitated the adoption of single-use bioreactors for biopharmaceutical manufacturing.

	Manufacturers of disposable bioreactors have continually worked to improve their systems to meet evolving needs for biologic drug substance production.

	This article explores recent advances in disposable bioreactor technology, the limitations that remain, and efforts that are underway to address them.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Single-Use Bioreactors Have Reached the Big Time

A look at how engineering-led companies from outside pharma are transforming biopharmaceutical contract services, and an interview with Samsung BioLogics’ vice president and head of business development, James Park, on the company’s history, culture, and plans.

Samsung BioLogics’ aggressive growth strategy begs the question: Are there lessons that US and European pharma might still learn from the electronics industry?

Parallel Processing

The approval of biosimilars for the US market has created a need for more efficient manufacturing processes.

	Manufacturers are developing processes for cost efficiency and reliability using newer technology to compete with innovator products manufactured with legacy processes.

	Innovations include more productive cell lines, single-use systems, and powerful analytical methods.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

Pharmaceutical Technology-05-15-2017