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Execution of fill and finish projects in the conflict of market requirements

The manufacturing and regulatory challenges that come with the rise of aseptic technology will inevitably impact project execution.

Changing scenarios, changing technologies: Biotech must get agile

Pipelines are increasingly diverse and volume demands uncertain. How can biotech players stay afloat in this changeable manufacturing landscape?

Is continuous manufacturing the best solution for your biotech facility?

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.

How can new GMP regulations inspire and improve biosafety?

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?

Continuous processing - present and future challenges

What's the key to successful implementation and operation of continuous processing? People.

Recording: How to succeed with agile and flexible biomanufacturing capabilities

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.

Speed up single use changeover with this one simple method

“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.

How can data integrity bring you closer to digital transformation?

While other manufacturing industries discuss Industry 4.0 and Big Data, pharma manufacturers are securing the integrity of their regulatory records.

CAR-T cell therapies trigger a pharma manufacturing revolution

Unique, personalised drugs like CAR T cells require a change in pharma manufacturing mindset.

The future of pharma where robots and workers co-exist

Where are the robots? Pharma 4.0 brings robots - and they bring new challenges and opportunities.

Are you ready? Making a robotics strategy

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?

Recording: Manage the challenges of 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.

Recording: Global serialisation and packaging trends

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.

Increasing flexibility with control strategy

The key to manufacturing a consistent, quality product is the control strategy and understanding the process and mitigating risk is crucial.

Recording: Complexity of wireless product temperature measurement under isolator conditions

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

Recording: Condition-based monitoring - addressing the untapped cost saving potential in pharma manufacturing

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.

Recording: Questions impacting the future of flexible manufacturing of biologics

In this webinar, you'll get the answers to the key questions around how to design for a flexible manufacturing facility for biologics.

Robotic solutions are changing the game of biotech

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.

Continuous manufacturing – how do regulators differ in their approach?

In the highly regulated pharmaceutical industry, what do global regulatory authorities think of emerging technologies like continuous manufacturing?

Trained staff: single-use implementation’s missing link

Implementing single-use technology in biomanufacturing sparks an overlooked question – what good is a single-use system with no one to run it?

Personalised drugs transform the way authorities handle GMP

With an increase of personalised medicine, regulatory authorities must approve products faster. What else have personalised drugs changed in GMP?

Risk drivers when designing a flexible manufacturing facility

Achieve true pharma manufacturing flexibility, support your business driver and satisfy regulatory authorities with focus on three key risk drivers.

Optimising continuous manufacturing with robotics

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 left its mark but where is it heading?

Single-use technology is pushing new boundaries, making strides in fill finish, continuous processes and even honing in on the 2,000 litre bioreactor.

Pharma manufacturing control strategy starts with the patient

A robust control strategy is a good manufacturing practice ‘must.’ So how do you get started on establishing this interdisciplinary game plan?

Get closure (and analysis) in pharma manufacturing systems

The FDA is in your facility, asking about microbial control of your closed process system. What do you do?

Robots are coming and they’re automating pharma research

What can pharma manufacturing gain from implementing robotics and automation in the earliest part of the pharma value chain – research and development?

Are PODs the future of flexible pharma manufacturing systems?

The pharmaceutical industry is slow to adopt advanced manufacturing systems but one company broke away from this reluctance and took a chance on PODs.

Get to know pharma-focused Quality by Design (QbD)

QbD principles are still not the standard for all manufactures’ pharmaceutical facility design. So why should the pharma industry take QbD more seriously?

Quality by Design - from patient to control strategy

Neglecting to develop a robust control strategy not only affects your business, but also holds severe consequences for the patient.

How single use systems could revolutionise fill finish changeover

Single-use systems can speed up changeover of fill finish production lines without compromising sterility. Could this be the “shortcut” to success?

The million-dollar question: stainless steel or single-use?

Sometimes, the right solution is a combination of technologies, which offers the most productive and cost-effective process in a fast and predictable way.

Realising the cost advantages of single-use technology

Pharma manufacturing embraces single-use technology, as it can simplify facility design and save cost. So how can engineers measure and capitalise on this?

Risk and reward with single-use systems in high containment

Implementing single-use technology in pharma manufacturing is possible with high containment drugs, but it means satisfying conflicting agendas.

Flexibility – the future of pharma manufacturing

From single-use systems to continuous manufacturing – which tools do you use to tackle the new pharma reality where agility and flexibility reign supreme?

Biotech facility concepts to tackle personalised medicine

When redoing the batch is not an option, how are pharma manufacturers preparing for the increased personalised medicine and cell-based therapies?

High containment becomes high priority in pharma

Implementing containment within pharmaceutical manufacturing, is a matter of how, not when. Which level of closure is necessary for your drug production?

What the personalised medicine boom is doing to facility design

Autologous cell-based therapies are moving are taking the world of pharma manufacturing by storm. What can manufacturers expect from personalised medicine?

What closed systems mean for bioprocessing facility design

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.

3 key approaches to pharma manufacturing control strategy

With many considerations like the patient, GMP compliance and production, where do you begin when outlining a control strategy for pharma manufacturing?

The value of a control strategy for legacy products

With this method, you can potentially convert 100 possible CPPs to a prioritised list of less than 10 CPPs.

Aseptic technology on the rise

Injectable drug production isn’t slowing down – and as a result, neither is aseptic technology. Find out what regulatory authorities think of aseptic production.

Step-by-step risk analysis for continuous manufacturing

With complex drug development and pharma manufacturing, you can’t skip the details. Risk Analysis and Mitigation Matrix (RAMM) is the ultimate catch-all.

Pairing continuous processing and single-use systems

Single-use systems offer unprecedented flexibility for pharma manufacturing. Why not take efficiency to the next level and add continuous bioprocessing?

A breakthrough for pharma manufacturing that is FDA approved

Why is continuous manufacturing so much more efficient compared with batch procedure, and what do the authorities have to say about it?

Pharma manufacturing process waves farewell to batches

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?

Bend it like bio: flexibility in pharma manufacturing

A new generation of biopharmaceutical manufacturing is upon us and it focuses on flexibility and operability. Pharmaceutical plant design is changing fast.

The challenges of personalised drugs - and some possible solutions

Personalised drugs have shifted pharma companies’ roles from manufacturer to solution provider, calling for new collaboration with clinical care segments.

Keeping up with continuous processes for OSD

When it comes to pharma manufacturing, new products beg for a little innovation. With increased speed to market, continuous processes are here to deliver.

Design drivers for flexible pharma manufacturing assets

Start the complex journey of facility design by finding your vision-driver fast. Is it flexibility, agility, simplicity, innovation or all of the above?

Take assembly and packaging to the next level with robotics

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.

Flexible facility design: to scale-up or scale-out?

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.

Biopharma manufacturing in tune with tech transfer

Don’t reinvent the wheel. Get in tune with technology transfer to apply lessons learned and knowledge from existing to new pharma manufacturing facilities.

Speed up launch of new products in the pharma industry

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.

Statistical process control: is it the right business strategy for you?

Developing robust statistical process control (SPC) can do wonders for your quality control. Ensure its lucrative implementation with a successful pilot.

Maximise efficiency, minimise interference in biomanufacturing

Good process design and segregation strategies can maximise efficiency and minimise interference in multi-product, multi-phase biomanufacturing facilities.

Single-use systems: not your average design management

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?

Webinar: Global serialisation and packaging trends

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.

Watch the recording

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Explore our articles

Webinar: Global serialisation and packaging trends