Manufacturing

The Freeze Drying of Biologicals

Recent trends

Although conventional freeze drying in vials is still the predominant format, lyophilisation in alternative formats, such as pre-filled syringes, and alternate technologies such as spray freeze drying are becoming more popular.

Lyophilisation Process Development

The development of optimised process for freeze-dried product is described. New available analytical tools are reviewed and different steps from early phase to life cycle management are covered.

OEE Systems and Software

Enhancing operational efficiency

Making the best use of the equipment and reducing costs are two of the key challenges among many that the manufacturers in general and pharmaceutical companies in particular strive to overcome. Overall Equipment Effectiveness software is a boon in addressing the said challenges and aids in enhancement of overall operational efficiency.

Demand-driven Manufacturing

Designing profitable supply chain

In life sciences, traditional supply chains were designed from the inside-out perspective. To adaptively meet actual demand from the customer and translate it into global trade-offs, supply chains need to be designed from an outside-in perspective.

Biopharmaceutical Operations

Developing the science

Drawing parallels with the semiconductor industry, the authors argue that biopharmaceutical firms are finally reaching a point where efficient operations are becoming critical, thus necessitating advanced research in biopharmaceutical operations.

Buying into Lean Pharma

The article is a 30,000 feet fly-by of the essential stepping stones leading to a sustained lean deployment. This pragmatic approach, based on personal successes and failures, has been proven in several industries and across three continents by the author.

Moving from R&D to Manufacturing Excellence

Relative separation of manufacturing and R&D (siloed thinking) continues to characterise the pharmaceutical industry. Managing operations in a holistic manner by investing on a common platform that meets the existing standards and integrates innovative technologies across plants and different functional departments can help the pharma industry keep ahead of future trends.

Controlling Production Process

Incorporating analytical methods

Taking new regulative guidance into account, the motivation for increasing process analytical technology systems from a scientific and administrative point of view is addressed here. Based on freeze-dried macromolecular systems, the current gains and challenges of NIR and Raman spectroscopy are discussed. The potential of spectroscopic techniques is described in more detail using the common excipient mannitol as an example.

Process Analytical Technology

Application in precipitation processes

Precipitation is a commonly used purification method when a pure crystalline Active Pharmaceutical Ingredient (API), excipient or intermediate with specific particle properties needs to be isolated from a multi-component process solution after a synthesis, extraction or bio-process. The main factors affecting precipitation processes and in-line process monitoring when Process Analytical Technology (PAT) based on in-line / on-line spectroscopic methods is applied, is discussed here.

Cell-based Potency Assays

Adhering to GMP standards

The means of measuring the biological activity of a new drug is of critical importance to its release. The process through which a manufacturer can achieve this measure should be clearly defined before pre-clinical studies are initiated. The quality and validation requirements of these studies are defined in a number of regulations but experience of interpretation of these guidelines is essential in establishing a regulatory-compliant assay.

Single-use Bioprocess Containers

Economics of usage in Asia

Extensive adoption of single-use products in manufacturing has shown considerable cost reductions by limiting initial capital costs, utilities required and cleaning validation etc. Do they promise the same benefits in the Asian manufacturing scenario, where overall cost of production and labour are  significantly lower than in the West?

Large-scale Biochromatography

What lies ahead?

Many new approaches have been considered for large-scale chromatography including membrane adsorbers. The benefits and drawbacks of these devices and their potential impact on the biopharmaceutical industry are discussed.

Eliminating Guesswork

Automating PAT for process control

Modern process analytical technology systems generate continuous quality monitoring and provide plant process controllers with highly useful process information to increase the productivity and adhere to higher quality standards.

Using Chemometrics in PAT

Investigating data from the process

Processes of today are often equipped with sensors and measurement systems collecting large amount of data. Chemometrics is developed to handle large amount of data for overview (monitoring) and relations between raw materials, process parameters, instruments and Critical Quality Attributes.

PLM solution in packing and labelling

The pharma industry can add value, reduce costs and improve the overall quality of its products by improving packaging and labelling processes, enabled by integrated Product Lifecycle Management solutions.

Pharmaceutical Manufacturing

Embracing process analytical technology

The idea behind Process Analytical Technology has been a proven technology in oil refineries, petrochemical, food 7a beverage and semiconductor industries. Pharmaceutical and Biotech companies can ensure improved quality, reduced scrap and enhanced productivity by learning from the experiences of these industries.

PAT and ROI

A holistic approach

Despite the advantages PAT offers to the pharmaceutical industry, many companies remain hesitant about its implementation due to high investment costs.

Ready-To-Use Technologies

Driving process excellence and product safety

Biopharmaceutical manufacturing processes like cell culture, harvesting and downstream purification are rapidly gaining importance as process robustness and assurance of product safety in these processes are being considered seriously. This article looks into the lean concepts and ready-to-use technologies that are gaining prominence in the manufacturing of biopharmaceuticals.

Lean Transformation

Superficial imitation or a paradigm shift?

True innovation is not achieved by superficial imitation or the isolated or random use of lean tools & techniques and systems ("know how"), but instead requires the "know why"-i.e., an understanding of underlying principles.

Identifying Counterfeit Drugs

An unexpected benefit of PAT / QbD

The spectroscopic signature of a product, developed for PAT, may also be used in the field to determine whether a product is real or counterfeit.

Anti-Counterfeiting Technologies

What makes them effective?

Only a cross-functional and integrated approach can be successful in defeating counterfeiting and fraud, as well as the diversion of pharmaceutical products.

Manufacturing Control Systems

The "next big thing" for the life sciences industry

Manufacturing Control Systems are likely to emerge as the new standard manufacturing solution by the end of the decade

Advanced Emulsification Technologies

Narrow drop size distributions in the nanometer region

High shear homogenizing and low pressure homogenizing open new pathways for fine emulsions with narrow drop size distributions. Their flexibility allows the introduction of exactly desired and validated shear forces.

Developing a Process Excellence Culture

In an increasingly competitive marketplace, the current organisational models for supply chains will no longer be effective. A process excellence culture will enable an organisation's resiliency and provide a competitive advantage to it in the future.

Pharmaceutical Manufacturers

Embracing Lean Six Sigma

Pharmaceutical manufacturers are looking to Lean Manufacturing and Six Sigma principles to help them boost operational efficiency and improve quality, while facilitating compliance.

BaychroMAT CellCount

A platform for online analytical measurements

Fully automated control of fermentation processes on the basis of cell count is now possible in a production environment for the first time.

Micro and Nanotechnologies

From R&D to drug delivery

Micro and nanotechnologies will have a high impact on the pharmaceutical industry making the way to personalized therapy for better treatment efficiency and fewer side effects.

Compliance with GMPs During Development

GMPs are necessary for the manufacture of biopharmaceuticals that are administered to patients enrolled in clinical trials. Gail Sofer discusses the approaches for compliance in the areas of cell banking, cell culture and downstream processing.

Biopharma in Japan

Japanese pharmaceutical companies have struggled to find a way into the global marketplace. According to Tadayoshi Kawasaki, with government support, it won't be long before Japan makes its presence felt worldwide in the development and manufacturing of biopharmaceuticals.

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Manufacturing & Processing - Serving India and Beyond

Having gained a strong foothold in India's domestic sector, one Haryana-based company specialising in super speciality injectable drugs is working towards expanding its place in the world pharmaceuticals market.

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Round Vibrating Screening

With high product quality, continuous innovation and improvement and over 70,000 unit sales in over two decades, Asia's largest separator manufacturer has proved its strength in providing the very best sieving machines.

Singapore Surges Ahead

UPLC presents the possibility to extend and expand the utility of conventional HPLC, a widely used separation science.

Redesigning Drugs to Enhance Performance

When a compound progresses to a medicinal product the complexities of disease, drug action, and the diversity of patient response can mean that nuances of drug behaviour may not be fully evident. However, new insights may emerge on more widespread use. These can provide ideas for new indications or better treatment of the existing indication.

Improving Pharmaceutical Manufacturing Performance

A four-year research project began in 2002 to study pharmaceutical manufacturing and deviation management performance. The analysis reveals five key outcomes that influence manufacturing performance.

Plant Automation in Pharma

An Asian perspective

Automation platforms that can be easily expanded to other process automation applications within the manufacturing facility would significantly reduce cost involved in ensuring regulatory compliance.

Single-Use / Disposable Technology

Considerations for biopharmaceutical facility design

Single-use / disposable technology offers a cost-effective and flexible process design for biopharmaceutical manufacturing facilities.

Ultra Performance Liquid Chromatography (UPLC)

UPLC presents the possibility to extend and expand the utility of conventional HPLC, a widely used separation science.

Superdisintegrants

An economical alternative

Orally disintegrating tablets are an emerging trend in formulation, gaining popularity due to ease of administration and better patient compliance for geriatric and pediatric patients.

RFID in Pharma

An Asian perspective

RFID is performing functions relevant to pharmaceutical distribution and administration.

Integration of Packaging Innovations

The earlier understanding that packaging is not consumed by the end-user, therefore it need not be considered an integral part of the drug, is fast fading off.

Proteomics

From Technology to Anti-Cancer Compounds

There has been a significant progress in the systems biology field during the last decade. Sudhir Sahasrabudhe explains how his company's application of proteomics technologies has resulted in the identification of novel disease targets, drug candidates and biological markers predictive of drug response.

Meeting Singapore's Chemical Needs

The pharmaceuticals industry makes a significant contribution to Singapore's economy. To strengthen this position and to foster future development, the Institute of Chemical and Engineering Sciences was established. Professors Keith Carpenter and KC Nicolaou talk about the institute's future aims.

Pharmaceutical Manufacturing in Singapore

As a thriving location with a proven track record in pharmaceutical manufacturing, Singapore has built up world-class capabilities throughout the drug-making process. Yeoh Keat Chuan explains how his country aims to strengthen its capabilities to become the biomedical centre of Asia.

Drugs, Lies and Regulations

Pharmaceutical counterfeiting is increasing, potentially putting the safety, possibly lives, of millions of patients at risk. Julian Mount explains what his company is doing to ensure and enhance patient safety.

Laboratory Automation Systems - LAS is More

Hospitals worldwide are increasingly looking to implement laboratory automation systems to ensure good practice. Kerstin Zumstein, Editor, Pharma Focus Asia speaks to Professor Sunil Sethi, National University, Singapore, about the wider implications.

Targeting Best Practice in Packaging

RFID is performing functions relevant to pharmaceutical distribution and administration.