Breaking News on Global Pharmaceutical Technology & Manufacturing

When the bioprocessing world headed towards New York's Javits Center in March 2014, our team of reporters were on call to bring you the best news and views from the show floor.

Will US track and trace law be enough to stop counterfeiters?

In light of the implementation of the Drug Quality and Security Act of 2013 in the US, which calls for the phased implementation of electronic tracking down to the package level, companies are looking at options to catch up and reduce counterfeiting at the same time.

Lack of investment in production of low margin drugs behind shortages says expert

The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.

'Podular' manufacturing to become facility norm within 5 years, say GEA and G-CON

‘Podular’ manufacturing systems will dominate facility design within five years, say G-CON and GEA who have teamed with Pfizer to create a flexible, repurposable and portable facility. 

The in-Pharmatechnologist.com team donned our spurs and moseyed on down to San Antonio, Texas to cover the developments from this year's American Association of Pharmaceutical Scientists show.

Amongst the talk of oral delivery methods and advances in bioavailability, we also scouted the convention's floor to bring you all the news AAPS 2013 had to offer.

Almac launches 'unique' radiolabeling service for ADCs; names Pfizer client

Almac says it is in a unique position to offer Carbon-14 ADME radiolabeling for the growing antibody-drug conjugate (ADC) market and has already performed the service on a Pfizer candidate.

What does clinically meaningful mean? US lawyer predicts biosimilar battles

Unclear terms in US biosimilars laws and the high cost of filing with the Food and Drug Administration (FDA) has set the stage for legal battles according to a lawyer who spoke at AAPS this week.

Non-oral FDCs are beneficial for patients and industry, say experts

Drug delivery experts say fixed dose combination (FDC) products for non-oral forms can benefit both the manufacturer and the patient.

GEA: 'Start of the end' of batch manufacturing as firm teams with US FDA

The US FDA is working with GEA to validate continuous manufacturing as the pharma industry enters “the start of the end” for batch manufacturing, according to GEA.

"Like I said, it's complicated" drug-food interactions discussed at AAPS

Understanding how a drug will interact with food is vital even if predicting it accurately during development can be a challenge according to speakers at AAPS yesterday.

Spray drying often most applicable in bioavailability challenge, says Bend

There are multiple ways to make amorphous dispersions in order to enhance bioavailability but spray dry dispersion (SDD) is often the most applicable, Bend Research says.

Drug industry heads to Texas for AAPS

[View the story "AAPS at the Alamo" on Storify]

Our editorial team avoided the Oktoberfest beerhalls of Munich in favour of the Frankfurt Messe and CPhI 2013. Though the journey from Frankfurt Hahn airport to the city centre was longer than the flight from our office in Montpellier (and almost our New York office too) the show produced a wide range of newsworthy stories:

Second generation HPMC excipient can cut costs by 60%, says Dow

A new tableting excipient eliminates the need for wet granulation and saves up to 60% on overall manufacturing costs according to developer Dow.

'The sexiness of the ADC world' - CMOs talk antibody-drug hybrids at CPhI

Piramal’s COO Vijay Shah described antibody-drug conjugates (ADCs) as “a concept whose time has come” at the CPhI annual report press conference and recent investors in the technology echo his words.

Novasep granted US FDA approval at two EU API facilities

French CMO Novasep has received the thumbs up from US regulators at two of its European API manufacturing facilities.

Risk-based supply chain management means more audits for excipient firms

Regulatory pressure for risk-based supply chain management is increasing excipient suppliers’ audit burden according to the team preparing to launch the 'excipact' certification scheme as an independent association.

Capsugel's purchase of Bend will strengthen partnership, says Dow

Dow says the acquisition of partner Bend Research is “good news” and will strengthen its developments in solving solubility and bioavailability issues in drug formulation.

Catalent launches softgel products at CPhI: one vegetarian, one anti-abuse

Catalent has announced two new softgel solutions as it adds greater versatility to its Advanced Technologies Business Unit.

McKinsey consultants help to pull Patheon off the road to bankruptcy

Patheon brought in McKinsey consultants over the last three years to help overhaul its sagging business and institute a number of simple process changes that resulted in deep transformations.

Cobra Biologics looks to reduce volume waste during fill/finish

A project to minimise the hold-up volume and losses in the fill/finish of biologics has reduced biologic waste ten-fold, says Cobra Biologics.

Frankfurt becomes Phrankfurt as drug industry gathers in Germany

Drugmakers, fine chemicals firms, delivery technology manufacturers and processing system developers from around the world meet in Frankfurt, Germany.

In April we adopted a “New York state of mind” and jetted to the Big Apple to “Start spreading then news” about developments in the pharmaceutical manufacturing and processing sectors. Here’s what we found out.

Capsugel: Micro-Dosing Tech Can Cut Drug Development by 6 Months

Capsugel says its Xcelodose Precision Powder Micro-Dosing System can shorten drug development time by up to six months. 

Thermo Fisher: Single-Use Tech's Evolution and Increased Industry Use

Over the last decade single-use technologies have moved into manufacturing scales and are increasingly being deployed worldwide, according to Thermo Fisher Scientific.

New DFS Unit Built on Technology, R&D and Manufacturing, says Capsugel

Following a busy few months, Capsugel spoke about the formation of its Dosage Form Solutions Unit, its technology and the integration of Encap at this year's Interphex in New York.

TFS Sees Increase in Modularization, Shorter Construction Timelines

Biopharma companies are looking for more pre-fabrication of their facilities and to be able to expedite construction and meet tighter timelines, an expert told Outsourcing-Pharma.com.

EMD Millipore Talks New Single-Use Chromatography Tech

EMD Millipore says its new chromatography tech can help manufacturers avoid compromising their processes when switching from multi-use to single use

ATMI: Single-Use Could Replace Multi-Use, as Potency Increases

Single-use is set to dominate biopharma processing as products become more potent resulting in smaller volumes, according to ATMI.

AlpVision's iPhone Tech Offers Authentication in War on Counterfeits

In the war against counterfeits, regulators have concentrated on serialisation and ePedigree and missed an opportunity on product authentication, according to AlpVision.

AMRI Exec Discusses 'New Bar' in FDA Enforcement

Following the completion of remediation efforts to deal with an FDA warning letter, Chris Phillips, AMRI's senior director of its Burlington, Massachusetts site, discusses what he considers to be a "new bar" in enforcement activity from the agency since 2009.

Customers to Save up to 65% as ASI and Chromatan Pen Single-Use Deal

ASI has teamed up with Chromatan in order to deliver single-use and column-free capture purification services which could save clients 65% in chromatography costs in clinical manufacturing.

Tech and Regulatory Issues? Biotech/Manufacturing Firms Discuss

Purification bottlenecks, integrating single-use technologies and low cost companies are just some of the issues affecting the biotech industry today, according to experts at this year’s Interphex.

IHolland Talks Tabletting Solutions for Sticky Formulations

IHolland says tableting-focused research project will save customers time and money.

Almac Talks Facility Expansions on Both Sides of the Atlantic

Almac says $10m investment at its recently expanded facility in Northern Ireland compliments the sites existing formulation development capabilities.

Experts: Real-Time Release Testing Desirable But Not Primary Goal of QbD

The US FDA is beginning to push CMOs and other manufacturers away from using real-time release testing as a shortcut to ensuring drug quality and reducing end product testing, experts said.

Regulatory and Financial Burdens Slow IR/MR Approvals, Says Expert

Efforts to update SUPAC guidance on immediate and modified release dosage forms will end in faster approvals, if regulatory and financial hurdles can be overcome, says expert.

Drug Industry gathers for Interphex 2013 - Check for live updates

Pharmaceutical conferences are like buses - to paraphrase an old British joke - you wait for one and then three come along at once.

Lack of Lava-Proof Planes Wont Stop Us Going to Interphex

So, look. Interphex is a great trade show. No doubt. 

PSL says demand for HPAPI containment growing

Powder Systems Limited (PSL) says the low OEL achieved by its redesigned containment technologies meet demands of HPAPI focused drug industry.

The drug industry gathered in Madrid, Spain in October for CPhI.

The in-pharmatechnologist.com editorial team were there to track down all the breaking news and speak with the movers and shakers about the latest industry trends.

Aesica ramps up HPAPI capacity to meet industry demand

The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is largely unmet, according to Aesica.

Cobra Biologics talks recent fill finish acquisition and future growth plans

CMO Cobra Biologics says North America is an obvious place to look at for a facility acquisition.

New import laws spur hopes for reduced trial start-up time in Ukraine

Ukraine hopes changes to import laws will help cut trial start-up time from six month to 45 days.

Penn Pharma in talks with the big boys over new facility

Penn Pharma is in talks with a number of “big players” over its upcoming high containment oral solid dose facility.

Piramal looking for injectables capacity but wont overpay

Piramal Healthcare wants to add sterile injectables to its offering but is unwilling to overpay for facilities owned by 'value focused' private equity groups.

Indian pharma regulations should not change to suit others, says the Government

Indian regulations should not change to suit Western GMP standards, according to the country’s Deputy Drug Controller.

BASF wants a share of pharma omega-3 market

BASF wants a share of the $1.5bn global market for drug grade omega-3 and expects the plant it is building to start shipping product early next year. 

Albemarle sees pharma ‘flight to quality’

Albemarle says it is seeing a flight to quality as pharmaceutical fine chemical customers begin to return to western suppliers.

Novasep to invest €30m in large-scale API production plant

Novasep plans to build the ‘world’s largest’ chromatography-based API production plant with backing the French government, banks and gas firm Total.

Mutual recognition agreements will solve global GMP woes, says EFCG

Mutual recognition agreements between Western regulators would help ensure a safe API supply chain, according to the EFCG.

CPhI Worldwide 2012: Networking, up-coming countries and bioavailability

in-Pharmatechnologist.com is going to Madrid, Spain to meet API and excipient makers, Biopharma firms, processing tech developers and contract services organisation gathered for one of the drug industry's biggest trade shows.

in-Pharmatechnologist.com went to Achema 2012 in June to track down all the latest developments in the pharmaceutical processing technology space. Here is a collection of our best read articles.  

‘Just add water’ for ease of cleaning HP production tech, says Bosch

‘Just add water’ as a preparation for cleaning the stand-in-place tech used to produce HP compounds, says Bosh’s Johannes Rauschnabel.

The quest for more understanding is behind the single use boom: Pall and Thermo Fisher

The implementation of single use technology in the biopharmaceutical fill and finish process has seen a massive uptick recently because of better industry understanding, according to Pall’s Bruce Rawlings.

Bosch plans to upscale its new X-ray capsule QC tech

Bosch Packaging says it is now developing a big batch version of its new X-ray capsule inspection tech.

New filtration tech boosts biomanufacturing yields, says Sartorius

Sartorius Stedim says its new range of sterilising-grade filters can allow steam cleaning in dry conditions and minimises protein binding.

Is drug delivery by skin the solution to bioavailability woes? report from Achema

Drug regulators and the biomanufacturing industry need to embrace drug delivery via the skin to solve solubility problems with peptides and proteins, according to Across Barriers’ Udo Bock.

Achema 2012: Safety, efficiency and single-use technology

Safety, efficiency, innovation and single-use tech are the buzz words at Achema 2012 in Frankfurt.

in-Pharmatechnologist.com breezed into Chicago, the windy city, for the American Association of Pharmaceutical Scientists' (AAPS) annual conference. We spoke with some of the drug industry's thought leaders and tracked down all the breaking news.

Low API and excipient volumes vital to win authorisation under EU PIP says EMA

Pharmas should use lower API and excipient volumes if seeking authorisation under the EU Paediatric Investigation Plan  (PIP) says the EMA.

Xcelience plans EU clinical trial supply expansion after opening new US plant

Xcelience is shopping for a European distributor after opening a new clinical trial supply facility in the US.

Catalent says sharing with industry will not dull competetive edge

Catalent says making its technology available to industry will not affect its competitive edge.

Eliminate scale up by using R&D equipment for commercial production: GSK

Using the same equipment from R&D to scale up will cut costs, time and improve efficiency, according to GSK.

Catalent aims to boost drug delivery through industry-academia partnership

Catalent has established a new institute in a bid to advance drug delivery by creating links between industry and academia.

Capsugel expands liquid fill capsule capabilities

Capsugel has expanded its Licaps liquid fill capsule line with a new facility in the US.

Bend Research hunting new partnerships to boost bioavailability offering

Bend Research is “actively” hunting new partnerships similar to its recent alliance with Dow.

Emerging market CMOs and their customers must make info easily available: FDA

Make information about generic production readily available when working with vendors in emerging markets for quicker US approval, says the FDA.

Remember regional Biosimilar regs and ref drugs differ, says Pfizer

Manufacturers trying to prove the similarity of their biosimilars must consider that regulations and reference medicines differ in different markets says Pfizer.

Peru's GMP requirements mean delayed approvals, says expert

Stricter GMP requirements in Peru are increasing the time it takes to get drugs approved and may not be giving regulators any useful additional information. 

Interphex 2012 was a busy show for the in-Pharmatechnologist.com team. In addition to meeting the movers and shakers in the pharmaceutical manufacturing and processing tech sectors, we celebrated the launch of our new look website with a dinner cruise on the Hudson with Manhattan's spectacular skyline as a backdrop.

But despite our hectic social schedule we still found time to do what we do best - report all the latest news and exciting developments in the pharmaceutical manufacturing space. And this year's show was as exciting and innovative as ever, as this collection of our best read news stories shows.

PTI stresses benefits of non-destructive testing at Interphex

PTI says its new non-destructive testing technology is uniquely positioned to help manufacturers reduce waste and save time and money.

Patheon launches CMC consultancy in face of restructuring plans

Patheon has launched a new consulting service designed to give emerging biotechs and pharmas a boost in their drug development efforts.

in-Pharmatechnologist.com's review of Interphex 2012

in-Pharmatechnologist.com was at Interphex 2012 in New York, US to launch the revamped version of our website and speak to the pharmaceutical manufacturing and processing tech sector’s movers and shakers.

Fette's 'common sense' approach to boosting production

Reduce changeover time on oral solid dose machinery by cleaning equipment offline, Fette Compacting urged drugsmakers at this year’s Interphex.

FDA oversight driving closures of CMOs; Interphex speaker

Increased oversight by the FDA is causing some US-based CMOs to shut down, a speaker at Interphex said.

Effective controls still lacking for continuous processing says Interphex panel

Continuous processing is still hamstrung by a lack of control systems and is not ready for specific FDA guidance according to an industry expert panel which met at Interphex last week.

Know how your CMO will deliver its promises, says Baxter

“Understand not only what your CMO can do, but how they can get it done,” was Baxter’s message during a speech at the year’s Interphex in New York.

Generics rise sparks delivery tech need; Interphex speaker

The need for novel delivery technologies is greater than ever as firms scramble to extract maximum value from drugs, an Interphex speaker said.

Single-use is the future of biomanufacturing: report from Interphex

Advancements in single-use equipment are crucial to the development of the biotechnology industry, according to experts at this year’s Interphex.

SGS adds formulation development services and expands US lab

SGS has added formulation development to its service offering through the expansion of its laboratory in Illinois.

Modular plants are “harbinger of change”; Interphex speaker

Modular plants are the “harbinger of change” in drug production and will allow for more flexible facility construction, a speaker at Interphex said.

in-PharmaTechnologist.com live at Interphex 2012

The in-Pharmatechnologist.com team is at Interphex 2012 to bring you all the latest news and details of the new techs that will shape the pharmaceutical manufacturing and processing sectors over the next 12 months.

The in-Pharmatechnologist team went to the American Association of Pharmaceutical Scientists (AAPS) conference in New Orleans, US to cover all the breaking drug industry news and trends and speak with key pharmaceutical industry movers and shakers.

For the full list of articles click the + More button below

Metrics discusses benzophenone migration at AAPS

US Contract research laboratory Metrics reveals that benzophenone, a component used in varnish on labels, is able to migrate through HDPE bottles to reach the pills inside.

Multiple strategies needed to beat counterfeiters

Only multiple anti-counterfeiting strategies are able to beat increasingly sophisticated criminals, according to a seminar on anti-counterfeiting at the recent AAPS trade event in New Orleans.

Monographs, heavy metals and globalisation on USP agenda

Updating monographs, changing elemental impurity tests and globalisation were discussed by the USP at its workshop and in interviews with in-PharmaTechnologist.

Phase I environmental testing helps waste handling decisions

Performing environmental testing early in a molecule’s development and including data in tech transfers to CMOs helps ensure there is little mass loading from pilot and commercial plants.

Anti-counterfeiting held back by self-interest & politics

Narrowly defined pharma self-interest and lack of coordinated political effort means, despite the best effort of some, the problem of counterfeiting may be worsening.

Capsugel sees demand for capsule filling tech improve in 2010

Demand for high-end capsule filling technologies, particularly those used for early clinical development projects, has increased in 2010 according to Capsugel.

Control excipient reactivity with packaging & aluminium lakes

Aluminium lakes and in-liner packaging can, in some cases, be used to control reactive components in excipients and therefore overcome drug product instability.

Will & desire needed to drive adoption of real-time release

The knowledge and means are in place to implement real-time release (RTR), a PAT pioneer said at AAPS, but questions remain about whether pharma has the will and desire.

Millions of dollars wasted on failed recruitment

Poor recruitment practices cost the United States pharmaceutical industry millions of dollars, warns a leading US biopharma recruitment agency.

Nose-to-brain delivery possible but challenges remain

Nose-to-brain delivery can become a reality, even for molecules with high molecular weights, but barriers relating to administration and adsorption remain, according to a panel at AAPS.

Industry, innovation & Viagra-stuffed teddies at AAPS

Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.

Globalisation is biggest challenge for supply chain security, says USP

Globalisation is the main challenge to drug supply chain security according to USP scientist Desmond Hunt, who says greater collaboration is the key to maintaining product integrity

Partnerships needed to beat public health counterfeit threat

Combatting counterfeit drugs through forging stronger partnerships is beyond profit, it is about saving lives, AstraZeneca principal scientist Dr Michael Claybourn told a workshop on global drug quality at the AAPS annual meeting in New Orleans.

USP building database of fake & substandard meds

The USP is building a database of counterfeit essential medicines to support international drug procurement organisations, such as WHO, and the timely sharing of information between national regulators.

in-Pharmatechnologist.com presents a round up of all the latest developments in pharmaceutical manufacturing, processing and production technologies that were unveiled at Interphex 2011.

EMD Millipore talks single use technology at Interphex 2011

How have single-use technologies changed drug production? How do you dispose of a disposable technology? What will drive the market going forward? EMD Millipore answered these questions and more at Interphex 2011.

PTI and Nikka Densok team on lab-scale HVLD

PTI Inspection Systems and Nikka Densok USA have teamed up to take high-voltage leak detection (HVLD) from the factory floor to the pharmaceutical lab.

LB Bohle sees increasing demand for ‘try before you buy’ demos

LB Bohle says healthy level of demand for processing technology demos at its recently opened service centre is an indication of processing tech market recovery.

Patheon talks about backup manufacturing service at Interphex 2011

Contract manufacturing organisation (CMO) Patheon has launched a new ‘back up’ sterile manufacturing service to help drug firms cope with supply interruptions and, it hopes, attract new business.

PAT and QbD changing powder flow analysis says Freeman

Regulatory demands for ‘in process’ performance data have changed the pharma sector’s approach to materials analysis and enhanced the quality of the drugs it produces according to Freeman Technology.

China’s booming pharma sector welcomes western investors

Double-digit growth in the Chinese pharmaceutical sector will increasingly make the nation a lucrative place for Western companies to do business, delegates heard at the InterPhex trade event in New York.

Pharma future bright for Puerto Rico says PRIDCO

The pharmaceutical manufacturing sector in Puerto Rico will thrive because of and not in spite of changes to the country’s tax and incentive laws according to the Puerto Rico Industrial Development Company (PRIDCO).

ATMI unveils helium integrity testing for bioprocess vessels at Interphex 2011

ATMI LifeSciences has introduced a new method of integrity testing for its range of single-use bioprocess vessels that, it claims, will take QA in the biomanufacturing sector to a new level.

China's new approvals system brings outsourcing opportunity

A new, tougher approvals policy for pharmaceutical products in China will bring opportunities for Western contract companies able to help domestic firms meet the strict new rules, according to a seminar at InterPhex in New York.

Planning key to cell therapies' $6bn growth

Planning the commercial production and delivery of effective cell therapies will be key if the sector is to achieve forecast growth of $6bn within nine years, according to a seminar at the InterPhex trade event in New York City.

US FDA opens Interphex 2011 with presentation backing continuous manufacturing

The US FDA set out its support for properly planned continuous manufacturing during a fascinating opening presentation at the first day of Interphex 2011 in New York, US yesterday.

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