Stage 1 On-Demand Sessions

What is retro commissioning and air balancing, are they different?  Or are they the same let's look at both and show the difference and what some of the cost benefits are.  What can they provide; can they help by lowering utility costs? How many hot or cold calls do you have in a facility each year?  How many times have you added equipment as you had space and not looked at the extra BTU,S required to maintain comfort by heating or cooling or the correct amount of fresh air for personnel comfort  and creating possible safety issues? . Retro Commissioning and Retro-Balancing are different let's discuss each and show the benefits of each and their limits.

No-Touch-Transfer (NTT) is an alternative methodology to introduce pre-sterilized RTU containers into aseptic processing grade A filling zones without disinfection steps (like VHP or e-beam) applied on outer packaging layers. The pre-sterilized containers and sterile barriers, with assured sterility at manufacture, are qualified to remain sterile through the supply chain and through the NTT de-bagging process (end-to-end). NTT is based on a GMP compliant process design of material transfers through changing GMP grades applying QRM. In this stepwise process, the content from the bag packaging is ejected without direct contact with contents or any exposure to a lesser grade of environmental contamination than the zone they are entering. The pre-sterilized RTU container assembly including packaging has to be designed and qualified for NTT. The presentation will detail the applied quality-by-design approach and qualification studies executed.

The compressed drug tablet is the most popular dosage form in use worldwide, but compared to many other industries, the equipment currently employed in the pharmaceutical manufacturing industry is often outdated. Problems in pharmaceutical tablet design/development and manufacturing have the potential to significantly impact patient care as failures in quality may result in serious harm to patients, costly product recalls, and perilous medicine shortages. The physical properties and structural integrity of a tablet often determine its performance and therapeutic attributes. The imperfections and irregularities within a tablet may adversely affect its physical-mechanical, chemical, and biological properties and performance.  In this presentation, we will review the key ultrasonic techniques and current technologies and discuss their critical quality assurance and monitoring applications in tablet design/development and continuous manufacturing.

Evaluation of the quality of polymer welds is essential to the development and production maintenance of a welding process. Weld evaluation methods can be categorized as destructive or nondestructive, and quantitative or qualitative. Each of these assessment types gives different types of information about the weld joint.  Perhaps the most difficult criteria to measure, but most important is whether intermolecular diffusion has occurred between the melt surfaces. Without this, the bond achieved is merely adhesive, and not a true weld. While the degree of intermolecular diffusion can be predicted theoretically, this process can be time consuming and inconsistent. Conversely, a simple destructive test, heating after cross-section (HACS), can provide a qualitative, if not quantitative, determination of whether intermolecular diffusion has occurred. In this session, the cross-section preparation process and evaluation method will be described and examples shared.

Mammalian cell cultures are widely used as the workhorse platform in the production of biological products including antibodies, other therapeutic proteins, and growth factors.

Particularly for bioprocessing, Raman spectroscopy has become attractive for in-line PAT applications given its inherent properties such as non-contact, non-destructive, high molecular specificity, and weak water bands for good quality analysis in aqueous solutions. Given the increasing interest for robust process design, optimization, and control in emerging intensified and continuous bioprocess platforms, Raman spectroscopy provides a great potential for real-time and in-situ measurement of relevant cell culture process parameters and product quality attributes.

In this session, we will present a general workflow and case studies on the implementation of Raman spectroscopy soft sensors for monitoring in bench-scale CHO cell intensified seed trains (N-1), steady state and dynamic perfusion (N) cultures.

In this presentation, you will get an overview of Oral Solid Dosage (OSD) Continuous Manufacturing (CM) in the Pharmaceutical Industry, what the benefits are, and what CM concepts are being used already in R&D and Manufacturing. This will be followed by an explanation of how to successfully develop two different CM process trains, Twin-Screw Wet Granulation (TSWG)/Fluid Bed Drying (FBD), as well as Continuous Direct Compression (CDC). The use of Process Analytical Technology (PAT) in development and manufacturing will also be discussed.

Vaporized Hydrogen Peroxide is a preferred bio-decontamination method in most Pharmaceutical Cleanrooms and Aseptic Isolators. To achieve the microbial contamination limit in these controlled environments, a robust bio-decontamination cycle needs to be developed and qualified. But a successful cycle depends on various factors. The commonly known factors are injection rate(g/min), dwell time(min), vapour flow etc. But the maintenance of these generator parameters in isolation is not sufficient to guarantee complete kill. An effective decontamination process also depends on external factors such as outside weather conditions, building HVAC system, site compressed air quality etc.

Silicones and thermoplastic elastomers (TPE) are two of the leading materials used for flexible biopharma process tubing.  While both polymeric in nature, silicone and TPE are fundamentally different materials, one built on a silicon-oxygen backbone and the other on a carbon-carbon backbone.  Both are flexible elastomeric materials, but silicone is a cured thermoset material while TPE is, as its name implies, thermoplastic.  These fundamental material differences lead to unique in-use properties for each material.  Both are great choices for biopharma tubing applications where purity, performance, and quality are essential.  The inherent property differences of these two materials dictate the applications where each tubing type excels.  In this talk, the intrinsic differences between silicone and TPE materials will be compared, and the biopharma process tubing use-case advantages of each tubing type will be showcased.

Before the COVID-19 pandemic, the manufacturing industry had been relatively slow to embrace the ongoing digital revolution. But the pandemic forced the life sciences industry and drug developers to rethink their hesitation toward digitization that could quickly produce and distribute new vaccines under unprecedented conditions. For the life sciences manufacturing industry, becoming a luminary of the lighthouse effect relies on using a mix of advanced technical capabilities and coming up with innovative applications for the technology. In the age of Big Data, artificial intelligence (AI) and digitization will play lead roles in achieving lighthouse effects. Lighthouse manufacturing techniques utilize technology and automation to streamline production. What does this mean from a facilities standpoint? Three key areas where lighthouse effects are enacting great change: more efficient buildings and products, better data evaluations, and faster production schedules.

With continuous manufacturing, reducing overall risk is critical, and instrument reliability is key to this process. With more reliable equipment, processes that used to run for only a few days are now extending runtime to weeks and even months. Extending process runtime reduces the number of times processes start and stop and the amount of equipment downtime. Longer runtime intervals are possible with predictive and preventative maintenance. With permanent diagnostics, verification and monitoring, process owners can check an instrument's health status, perform in-line/in-situ verifications and calibrations that provide traceable documentation at any time without process interruption. The ability to check the health status of an instrument eliminates issues or failures, reduces process downtime, and ensures optimal performance and planning cycles.

EU GMP Annex 1 is the primary document that governs the manufacture, control, and release of Sterile pharmaceutical products. Its long-anticipated release is likely due in mid-2022. 

The last major revision for Annex 1 was 2007, and for FDA guidelines back in 2004.  Much has changed in Pharma in the last 20 years!  The impacts of Annex 1 are not just for those companies in Europe, but for anyone that will be releasing products into the European market. The fundamentals of Annex 1 are likely to be cascaded out to other regulatory bodies, PIC/s, WHO, and FDA. It will have a global reach.

Unless companies are already up to speed and compliant, this does not give a lot of time to implement the far-reaching requirements of Annex 1 given the bureaucracy of most of our organizations.  So how would you know if you are ready for implementation or now? With your limited resources on-site, what are your priorities and what do you tackle first?