Newsletter | December 5, 2024

12.05.24 -- Facilities Design/Manufacturing Controls

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FOCUS ON FACILITIES DESIGN & MAINTENANCE

UK To Implement Novel Framework For Point-Of-Care Manufacturing

It will be the first country to introduce a tailored framework for innovative medicine manufacturers at or close to where patients receive care.

Oligonucleotide Manufacturing: Take Control Of Your Process

What do you need to know before you take your process in-house? A team of experts on nucleic acids therapeutics outlined five key things for you to consider as you make the change.

Navigating 5 Overlooked Challenges In Bioconjugate Manufacturing

Delve into the intricacies of ADC production and learn how cutting-edge technologies are being deployed to overcome these hurdles to bring life-saving treatments to patients.

Your Capital Equipment Project Is Cancelled - Now What?

Late-stage clinical trial failures usually result in exposure with regard to capital equipment purchased to manufacture that product at a commercial scale. But what to do with this brand new, surplus equipment?

How To Measure Particulate Contamination Levels In Single-Use Systems

Compare single-use system bags, focusing on their design, materials, and applications to better understand why controlling particulate levels is critical to maintaining product purity and efficacy.

Biologics Manufacturing Innovation For Medicine Supply Security

Explore a strategy of building a global network of modular-designed large-scale and single-use facilities to allow customers to rapidly ramp up production and transfer processes.

Performance Characteristics Of The Mobius ADC Reactor For Conjugation

Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.

Connection Technologies Enable Modular Single-Use Systems

Single-use systems are increasingly prevalent in biotechnology processes, and modular strategies offer adaptability and several other benefits. Explore the benefits, challenges, and solutions presented by modular single-use systems.

Airborne Particle Sampling Techniques

ISO 14644-21:2023 is a new standard for airborne particle sampling. Marc Machauer and Mark Hallworth discuss the standard, with Mark providing insights into its development.

Tips For Designing A Single-Use Manifold For Advanced Therapies

Expert single-use engineers address six common questions posed by cell and gene therapy manufacturers in the design of custom single-use manifolds for the critical handling of biological fluids.

Stem Cell Cultivation In Single-Use Stirred Tank Bioreactors

Explore a study aimed at achieving clinically relevant cell numbers using the engineering of a GMP-compliant large-scale platform is essential.

Project Management: Sphere Of Influence

The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.

FACILITIES DESIGN & MAINTENANCE SOLUTIONS

Mobius ADC Reactor - MilliporeSigma

Cleanroom Technology For Unparalleled Cleanliness and Speed - AES Clean Technology, Inc.

Modular Environments For Biomanufacturing Capacity - Cytiva

FOCUS ON MANUFACTURING CONTROLS

Defining When To Implement Technologies To Support Commercial Growth

Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.

Biomolecular Characterization With Mass Photometry

What is mass photometry and how is it used? Explore this powerful analytical technology that measures the mass of single particles in solution accurately and without labels.

T-Cell Manufacturing: When Is The Right Time To Automate?

Automation enhances efficiency and minimizes contamination risks and labor costs. Despite the initial investment in automation equipment, the long-term savings can be significant.

Enabling Real-Time Process Control

Defined control strategies enable more intensified and stable cell culture processes such as perfusion which may see dramatically improved productivity.

Technology Transfer And The Need For Digital Transformation

The right data management platform can streamline biopharma technology transfer by bridging digital gaps, accelerating commercialization, ensuring compliance, and reducing costs.

DataOps: The Missing Link In Your Pharma 4.0 Architecture

A new category of software solutions is emerging that may be the key to digital transformation for life sciences companies. Learn in-depth about Industrial DataOps for manufacturing environments.

Screening And Selection Of Monoclonal Antibody Drug Products

Learn more about a differential scanning calorimeter that offers thermal stability screening of buffer formulations and protein sequence modifications.

How A Pharma Manufacturer Reduced Line Stops, Increased OEE Up To 11%

Gain insight into how a leading pharmaceutical company identified the root cause of long-standing inefficiencies and optimized performance and productivity with unprecedented speed and accuracy.

Maximizing Efficiency In Biopharma Process Development

This powerful and easy to use batch planning strategy combines bioprocessing software and parallel bioreactors, enabling you to potentiate process development.

MANUFACTURING CONTROLS SOLUTIONS

Quality Risk Management Software - MasterControl, Inc.

Leave Paperwork Behind In Your CQV Process - ValGenesis

Easy-To-Use 1 mL Disposable Autoinjector - BD Medical - Pharmaceutical Systems

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