TechTalk | NNE

Welcome to TechTalk

Discover articles from the overlapping worlds of pharmaceuticals and engineering. TechTalk taps into industry challenges and explores solutions using focused pharma engineering expertise.

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.

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 biotech’s use of robotics goes from first-mover to standard.

Continuous manufacturing – what regulators really think

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 medicines 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

Among other segments, robotics can help pharma companies reach the goal of a continuous manufacturing. So what have robotics got to offer?

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 holds severe consequences for the reason pharmaceutical companies exist in the first place – the patient.

Speed up fill finish change-over with single-use systems

Single-use systems can speed up change-over 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.

Pinching pennies with 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.

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 big breakthrough – continuous pharma manufacturing

The pharma manufacturing industry can’t stop asking: What kind of efficiency is achievable with continuous manufacturing versus batch procedure?

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.

Personalised drugs transform pharma manufacturing

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?

Process insight without stopping production

When stopping production is not an option, how do you increase process understanding and improve quality? Meet the control strategy ‘Evolution Operation.’

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.

The first (and most important) step of Statistical Process Control

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. What does it take to manage their design?

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