The benefit of automating human involvement in production and the cost vs return. The continual improvement process to drive process changes, utilizing low cost...

Research underway at Innopharm Labs' pilot facility in Dublin, Ireland, combines the concepts of Industrial Internet of Things (IoT), Industry 4.0, machine-to-m...

High-throughput bioreactor robotic systems have started to replace traditional, labor and time intensive methods of using shake flasks and stirred tank reactors...

Speed to market continues to be a critical need for pharmaceutical companies expanding and/or launching new products to the marketplace. Whether it's deploying ...

Freeze drying has traditionally been a batch process making it both, time consuming and energy intensive (Rambhatla et al., 2003; Liu et al., 2008). While the u...

When bringing a molecule from the bench to market, there are many important considerations that biopharma executives must take into account throughout the journ...

The PCMM Collaboration brought together the expertise of Pfizer, GSK, GEA, and G-CON to collectively develop the next generation OSD manufacturing platform to a...

The benefits of single-use technologies are well known throughout the industry, but as the number of process consumables increase, so does the complexity to man...

This session will provide an overview of direct compression and wet granulation processes including updated information on how to remove production cost and exc...

The pharmaceutical industry has made progress in implementing continuous manufacturing for oral solid-dosage drugs. Commercial processes have been approved, and...

The pharmaceutical and biotechnology industries often utilize vessels with cone bottoms. Cone bottoms are selected to enhance product recovery and improve clean...

♦Today, both the MHRA and FDA are highly focused on data integrity and currently discourage methods by which data is recorded manually. Modern data management s...

Cleaning validation projects involve a lot of different departments and resources within pharmaceutical manufacturing. One of the most critical steps within th...

The quest by leading pharmaceutical and life sciences companies to achieve Continued Process Verification has begun in earnest. Originally a guidance issued by ...

TOC and conductivity are required tests to meet compendial requirements for pharmaceutical waters, but that is not the only use for TOC. Many industry manufactu...

Biopharma companies seek innovative solutions to solve their present and future manufacturing needs. Flexible and scalable manufacturing systems incorporating m...

Rotor / GXR technology was used for development of oral solid products at CMIC CMO USA and Freund Vector, such as taste masking, drug layering, etc. This novel ...

Ethylcellulose is a widely used polymer in the formulation of modified release drug delivery systems; applications are either using organic solvent or fully for...

Your business has to be flexible to survive and thrive. A flexible facility tailored to the business needs of your company will save you money. A flexible facil...

In this session, experts will discuss advances in lyophilization technology, with lessons learned from academia and other industries.

Start-up companies often have their beginnings in a crowded flex space. After years of research and testing, they finally developed a viable product. This is ...

Aging is an unavoidable part of a facility's life cycle. It is imperative that the facility owner constantly evaluate the impact of aging to the prime purpose ...

A completely new and innovative truly continuous drying process will be introduced to the audience. This new technology is implemented in an R&D machine for lab...

To date, the adoption of continuous manufacturing technology for bioprocessing remains slow, and where the technology is being used, it is limited to either dow...

Don't wait until your facility is overrun! Come learn how CRB approaches effective strategies for segregation of viral vector production, as found in gene thera...

The absence of microbial contaminations is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safe...

The manufacture of mAb-based products represents a large portion of many company's drug substance pipeline. In order to ensure that critical business goals focu...

Many business needs can be satisfied by providing unique identification on solid oral dosage forms. But there is truly only one purpose: patient safety. Manag...

This presentation will review surface selection criteria to design a pharma production area to address ambient conditions, usage specification and lifecycle ex...

For a multi-site organization, allocating demands can be a challenging problem. Computer simulations, in conjunction with mathematical modeling, can be used to ...

The goal is to highlight the links between the different regulatory updates regarding steam sterilization management, validation and requalification. In particu...

Risk analysis: Present state and industry's demand Dr. A. Fedotov, Clean Technologies LLC, Moscow, Russia 1. ICH Q9/EU GMP on risk analysis – are they correct ...

With growing demand in the biologics CDMO market, Merck KGaA (Darmstadt, Germany) elected to expand capacity at its existing cGMP biomanufacturing facility in M...

One of the key areas for ensuring that cleanrooms remain within microbiological and particulate specifications as laid out in ISO 14644 or Annex 1 of GMP is dis...

Introduce new technologies that provide more accurate defect detection and improve false reject rates to produce safer products for patients.

The pharmaceutical industry's competitive environment of today demands advanced process solutions which improve manufacturing efficiency and profitability. Proc...

Fill/finish operations represent perhaps the last frontier of significant risk in manufacturing injectable medicines. Closed systems in compounding and formulat...

Today's small number of approved cellular therapy products (13 FDA-approved), a large number of clinical trials (>10,000), and favorable regulatory climate, as ...

Continuous processing holds the promise of revolutionizing our approach to manufacturing and quality, but that promise is based on having a fully developed proc...

Dr. Yu is currently the Deputy Director of the Center for Drug Evaluation and Research's (CDER) Office of Pharmaceutical Quality, Food and Drug Administration (...

Gaining value from production data takes time and often requires specialized expertise. Project Scio reduces these efforts by allowing any user to securely acce...

Design and quality of water system equipment play a big role in optimizing pharmaceutical manufacturing - a huge, profitable and easily accessible potential. W...

GMP facilities are increasingly challenged to accommodate production diversity, adapt to evolving business needs, and deliver high quality products with low cos...