Zenith Case Study

Case study: MES Centre of Excellence

The Challenge A global pharmaceutical company with sites worldwide had a requirement to standardise their Manufacturing Execution Systems across four sites. In order to achieve this they wanted to create an MES Centre of Excellence (CoE) that would sit above all sites and provide leadership, best practices, research, support and training. The CoE needed to be tailored to the customer’s …

Zenith Serialisation Whitepaper

Overcoming the practical challenges of Pharmaceutical Serialization

Is Pharmaceutical Serialization on your radar? With new regulations either being implemented or pending should it be? Serialization entails adding a unique identifier to single saleable units of prescription and some other medicines so they can be tracked and authenticated throughout the supply chain. Requirements for serialization are already active in some parts of the world and they will be …

quality control, QA, quality assurance, QA, QC, manufacturing, efficiency

Download: QA, QC practices in manufacturing to ensure efficiency & quality

Dr Pradeep Nagalkar, Head Quality Control (Bio. & Chem.), Haffkine Bio-Pharma. Corp. Ltd., Mumbai gave a presentation on QA, QC Practices in Manufacturing to Ensure Efficiency & Quality at BioPharma India Convention 2014. Download the presentation to learn: What is Quality Control Importance of Quality Control in Biopharmaceutical Industry Advantages of Quality Control What is Quality Assurance (QA) What is the difference between …

biopharma, biopharmaindia, india, manufacturing, cellculture, culture medium, media, media preparation, single-use, single-use technology, processing trends, biopharmaceutical processing, biopharmaceutical

Download: Powder Culture Media Packaging, Preparation and Market Trends

This whitepaper from Thermo Fisher reviews the impact from recent trends in biopharmaceutical processing on the usage of culture media and its packaging. Current media preparation problems, future trends, and alternatives to media prep practices are discussed. The findings and commentary from on-line survey of 24 large-scale culture media end-users together with in-depth phone interviews are presented to evaluate relevant …

Download the Infographic: Facts and Figures of High Potency API Manufacturing

In last week’s blog post we covered the A-Z of HPAPI – High Potency API – giving you a preparative guide ahead of this November’s World High Potency API Congress. This week, it’s the turn of the facts and figures that are driving the incredible, and fast-pace, development of this pharmaceutical sector upwards. View Total BioPharma’s HPAPI Infographic here >  …

Top 25 Representatives in Bioprocessing

Top 25 Representatives in Bioprocessing

This is the question we asked our subscribers, LinkedIn group members and anyone in our contact network to compile a comprehensive list of the Top 25 Representatives in Bioprocessing, as named by you. Download this ebook now. The following 25 personalities have been chosen based on their career achievements, whether this was ground-breaking discovery and research, or innovation, funding, lifetime dedication …

BioPharma Mexico is where experts like SP Scientific meet to network, learn from each other, and discuss the latest developments in biopharma.

SP Scientific Shares Expertise on Controlled Nucleation in Freeze Drying

Mark Shon is Vice President of Technology Development for SP Scientific. His career includes over 20 years managing businesses that primarily develop and manufacture equipment for Life Sciences research, development and production. We were glad to have Mark join us for last year’s BioPharma Mexico. During the second day of the event, he gave a presentation on controlled nucleation in …

HPAPI Safety

What is the key to safe highly potent active pharmaceutical ingredient (HPAPI) manufacturing?

Innovating highly potent active pharmaceutical ingredient (HPAPI) production philosophies can ensure safety for those involved in their manufacturing, but what are the best pathways to innovate whilst reducing risks?   The fast growing HPAPI sector fosters huge potential, and with an annual growth rate exceeding double figures, it has become something of a ‘promised land’ to many CMOs. The market …

The Cell Culture World Congress USA is where experts like BPTC gather to network, learn from each other, and discuss the latest cell culture industry developments.

BPTC Shares their Insights on cGMP Manufacturing Using Single-use Bioreactors

The use of production scale, single-use bioreactors for cGMP manufacturing is now an accepted option for production of clinical and even commercial biopharmaceutical products. Early adapters are now routinely using 1,000 – 2,000 L single-use bioreactors to manufacture biopharmaceuticals for use in multiple countries worldwide. As outlined in this whitepaper, single-use bioreactors are being utilized to both add cGMP capacity …