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Read how advanced statistical analytics methods can lead to 30% increase in average yield and 70% reduction in yield variation from batch to batch.
The manufacturing and regulatory challenges that come with the rise of aseptic technology will inevitably impact project execution.
Pipelines are increasingly diverse and volume demands uncertain. How can biotech players stay afloat in this changeable manufacturing landscape?
The benefits of continuous manufacturing are clear, but does that mean that it is the right solution in any facility? Find out about the pitfalls and whether it is right for you.
The core focus of GMP is protecting the product and the patient. The core focus of biosafety, on the other hand, is protecting the operator and the environment. The challenges are different, but could the solutions be the same?
What's the key to successful implementation and operation of continuous processing? People.
Process architecture holistically integrates process and operations understanding with facility architecture to create a design that meets GMP. But it requires insight, creative thinking, and innovative ideas that meet customer requirements to provide flexible and future proof solutions.
“Single minute exchange of dies” (SMED) - a lean production method used in many other industries (and NASCAR pit stops) could be the single use system game changer.
While other manufacturing industries discuss Industry 4.0 and Big Data, pharma manufacturers are securing the integrity of their regulatory records.
Unique, personalised drugs like CAR T cells require a change in pharma manufacturing mindset.
Where are the robots? Pharma 4.0 brings robots - and they bring new challenges and opportunities.
The fourth industrial revolution is upon us and emerging technologies like robotics are dominating the manufacturing industry. Is your pharma facility ready for robotic solutions and pharma 4.0?
Control strategy is hot right now - it's a requirement, and it's good business. It is also a focus point for the FDA, issuing 5 warning letters in August and September alone. Get up to speed on control strategy with this webinar.
Faced with global political pressures to drive down the price of medicine, there is no doubt that reducing packaging costs gives pharma manufacturers the competitive edge.
The key to manufacturing a consistent, quality product is the control strategy and understanding the process and mitigating risk is crucial.
How do you successfully implement wireless product temperature measurement for isolator filling processing? Get the answer from Franz Bosshammer who presents a recent case study and a roadmap for handling this complex task
See the recording from NNE and Bigfinite’s joint event and learn how quickly you can gain value when implementing condition-based monitoring solutions by using Bigfinite’s newest cloud-based technology for operational intelligence.
In this webinar, you'll get the answers to the key questions around how to design for a flexible manufacturing facility for biologics.
With the FDA encouraging the use of innovative technologies, it’s only a matter of time before the use of robotics in biotech goes from first-mover to standard.
In the highly regulated pharmaceutical industry, what do global regulatory authorities think of emerging technologies like continuous manufacturing?
Implementing single-use technology in biomanufacturing sparks an overlooked question – what good is a single-use system with no one to run it?
With an increase of personalised medicine, regulatory authorities must approve products faster. What else have personalised drugs changed in GMP?
Achieve true pharma manufacturing flexibility, support your business driver and satisfy regulatory authorities with focus on three key risk drivers.
Robotics can help pharma companies reach the goal of continuous manufacturing. But what else have robotics got to offer the pharmaceutical industry?
Single-use technology is pushing new boundaries, making strides in fill finish, continuous processes and even honing in on the 2,000 litre bioreactor.
A robust control strategy is a good manufacturing practice ‘must.’ So how do you get started on establishing this interdisciplinary game plan?
The FDA is in your facility, asking about microbial control of your closed process system. What do you do?
What can pharma manufacturing gain from implementing robotics and automation in the earliest part of the pharma value chain – research and development?
The pharmaceutical industry is slow to adopt advanced manufacturing systems but one company broke away from this reluctance and took a chance on PODs.
QbD principles are still not the standard for all manufactures’ pharmaceutical facility design. So why should the pharma industry take QbD more seriously?
Neglecting to develop a robust control strategy not only affects your business, but also holds severe consequences for the patient.
Single-use systems can speed up changeover of fill finish production lines without compromising sterility. Could this be the “shortcut” to success?
Sometimes, the right solution is a combination of technologies, which offers the most productive and cost-effective process in a fast and predictable way.
Pharma manufacturing embraces single-use technology, as it can simplify facility design and save cost. So how can engineers measure and capitalise on this?
Implementing single-use technology in pharma manufacturing is possible with high containment drugs, but it means satisfying conflicting agendas.
From single-use systems to continuous manufacturing – which tools do you use to tackle the new pharma reality where agility and flexibility reign supreme?
When redoing the batch is not an option, how are pharma manufacturers preparing for the increased personalised medicine and cell-based therapies?
Implementing containment within pharmaceutical manufacturing, is a matter of how, not when. Which level of closure is necessary for your drug production?
Autologous cell-based therapies are moving are taking the world of pharma manufacturing by storm. What can manufacturers expect from personalised medicine?
Closed systems can prevent the contamination of products, workers and a facility. It’s no wonder that this technology is becoming a foundation for biotech system design.
With many considerations like the patient, GMP compliance and production, where do you begin when outlining a control strategy for pharma manufacturing?
With this method, you can potentially convert 100 possible CPPs to a prioritised list of less than 10 CPPs.
Injectable drug production isn’t slowing down – and as a result, neither is aseptic technology. Find out what regulatory authorities think of aseptic production.
With complex drug development and pharma manufacturing, you can’t skip the details. Risk Analysis and Mitigation Matrix (RAMM) is the ultimate catch-all.
Single-use systems offer unprecedented flexibility for pharma manufacturing. Why not take efficiency to the next level and add continuous bioprocessing?
Why is continuous manufacturing so much more efficient compared with batch procedure, and what do the authorities have to say about it?
The FDA appreciates continuous processes and they can save time and money during pharma manufacturing. So why is the industry hesitant to adopt this method?
A new generation of biopharmaceutical manufacturing is upon us and it focuses on flexibility and operability. Pharmaceutical plant design is changing fast.
Personalised drugs have shifted pharma companies’ roles from manufacturer to solution provider, calling for new collaboration with clinical care segments.
When it comes to pharma manufacturing, new products beg for a little innovation. With increased speed to market, continuous processes are here to deliver.
Start the complex journey of facility design by finding your vision-driver fast. Is it flexibility, agility, simplicity, innovation or all of the above?
Robotic solutions are more affordable than ever the pharma industry is catching on. Learn how assembly and packaging lines are ready to reap the benefits.
How do you ensure your resources match the wide scale of your facility? Learn which key challenges to prioritise from capacity needs to segregation strategy.
Don’t reinvent the wheel. Get in tune with technology transfer to apply lessons learned and knowledge from existing to new pharma manufacturing facilities.
In an industry plagued by delays, the automation standards S88 and S95 might be the solution to speed up tech transfer and launch products faster.
Developing robust statistical process control (SPC) can do wonders for your quality control. Ensure its lucrative implementation with a successful pilot.
Good process design and segregation strategies can maximise efficiency and minimise interference in multi-product, multi-phase biomanufacturing facilities.
A flexible and cost-effective solution to stainless steel, single-use systems may revolutionise the pharma world. But what does it take to manage their design?
Watch the recording of Global Technology Partner Lars Olsen's webinar, and learn more about evolving regulatory trends around serialisation, and ways to lower business risk and cut production costs by utilising the latest packaging trends.