Though famous for Comic-Con, San Diego's conference centre was full of different super-heroes for five days: those of the American Association of Pharmaceutical Scientists (AAPS) and our editorial team traveled from France and New York to bring you the news and views from the pharma community.
Rottendorf is looking to break from being “the best kept secret in the CMO world” by targeting the thousands of virtual and SME pharma firms in the US, according to its CEO.
How can a pharma company invest in continuous manufacturing without bleeding money when it retreats from a local market? Pfizer’s answer is production pods it can roll out anywhere in the world via helicopter… and pack away again if a market turns.
Single-use continues to be adopted by the bioprocessing industry, but drugmakers are still hesitant to use disposable chromatography systems, says EMD Millipore.
Sponsors are turning to outsourcing earlier for help with bioavailability formulation, say contract research organisations (CROs)
Lack of funding is threatening development of a nasal spray vaccine shown to provide long-term protection for non-human primates against the Ebola virus, the lead researcher told this publication in an exclusive interview.
Transdermal delivery using microneedles is an attractive and feasible administrative route for peptides, according to a Merck & Co. Director.
Extractables & leachables are the number one problem holding back the adoption and scale-up of single-use technology, according to a WuXi Apptech Director.
GSK is keeping its Ebola vaccine production in-house, despite previously leaked documents which suggested the company could not ramp up volume of BS-2 manufacturing without impacting its other vaccine lines.
BARDA, the US government’s Biomedical Advanced Research and Development Authority, has revealed it sees Ebola “as a bioterrorism threat.”
Using encapsulation machinery that is well serviced and appropriate to the type of powder being used can save drugmakers hundreds of thousands of dollars, according to Capsugel
A Pfizer Director has called for clearer manufacturing commitments in NDA and post-approval applications and the US FDA says, following its restructure, this will come.
Kemwell’s daughter company Cirrus will start manufacturing pharmaceuticals for clinical trials out of a GMP suite set to open in North Carolina.
A vaccine candidate which treats opioid abuse could help patients recover from heroin and Oxycontin addictions.
Analytical and bioanalytical service provider SGS has made significant changes to its global network over the past few months to stay ahead of the competition curve.
Addicts struggling to kick a meth habit could be helped by gene therapy according to the team behind a US National Institutes of Health funded project.
Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed countries (LDC), according to a GSK scientist.
As manufacturers begin to implement new RTRT (real-time release testing) models, a US FDA expert on the matter is offering additional help.
[View the story "Cali-pharm-ia: Live from AAPS 2014" on Storify]
In the future pharma will be reliant on technology, says physician-scientist Daniel Kraft, who warns that companies which fail to innovate risk being left behind.
CPhI Worldwide 2014 was held on home turf for our editorial team, albeit four hours by train away from our base in the sunny South of France to the rainy capital, Paris. Despite inner-city transport problems the event was, as usual, crowded but accompanied with by our New York editor we scoured the floors to bring you the best the Villepinte Conference Centre had to offer.
Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.
Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.
Changing pills to a more user-friendly formulation can increase patient compliance, brand loyalty, and extend IP exclusivity, says CMO Hermes in an exclusive podcast.
Strategic relationships with contract manufacturers are becoming the standard, but big and small pharma demands differ considerably according to the two largest CDMOs, DPx and Catalent.
Government contracts guaranteeing market share in Brazil are starting to attract innovators like Roche, Novartis and Sanofi and may see API suppliers get long-term work according to a spokesman for Sao Bernardo do Campo-based drugmaker, EMS.
Overzealous and unnecessary quality demands by some regulatory agencies are driving up the cost of medicines, according to the Indian Government.
Royal DSM has launched a statin API it claims is made using a green production method that reduces reliance on intermediate suppliers.
Aesica has turned its back on sterile injectables manufacturing and, in an exclusive interview, told Outsourcing-Pharma.com there is now limited steriles capability in the UK following the exit of other key players.
The pharmaceutical industry must change its ingredients and manufacturing methods to cash in on the enormous purchasing power of European Muslims, says an expert.
Biomanufacturing costs and the risk of extractables and leachables can be reduced by developing more compatible plastics, Sabic told Biopharma-Reporter.com at CPhI in Paris.
[View the story "Pharma industry goes to Paris" on Storify]
The sharing of audit reports for active pharmaceutical ingredients (APIs) is essential in order to help avert the global decline in quality, according to Hovione’s CEO.
The world is getting larger, at least it is in terms of the pharmaceutical industry, according to execs who cite security concerns when shipping to new markets as the top logistics worry.
Making active pharmaceutical ingredients (API) is a dirty business and you’d have to be pretty green to believe claims drug industry 'demand' will create a $100bn market for environmentally-friendly production methods by 2020.
TechnoPharm returned to the Nuremberg, Germany Exhibition Centre after 18 months away to showcase the latest clean and certified processes for the pharma industry.
Accompanying TechnoPharm was one of the largest shows worldwide for powder, granule and bulk solids technologies, POWTECH, reflecting the current state of the art in mechanical processing technologies and instrumentation and - according to the show programme - it's going to be explosive!
And in-Pharmatechnologist.com was here, despite the best efforts by certain French airlines, to bring you the latest innovations, thoughts and news from the two shows.
Drugmakers will “inevitably” shift from batch to continuous production of tablets and, according to Freeman Technology, a quality by design (QbD) approach is a fundamental requirement.
Including explosion protection in initial facility plans can save money in the long-term, according to Rembe, especially as drugmakers continue to work with more volatile ingredients.
A laser diffraction imaging tool could be used by quality controllers to help measure particle size in a suspension according to Malvern Instruments.
Flexible inkjet printing and personalized medicine will grow the market for orodispersible delivery technologies according to experts at a conference in Germany this week.
Development of continuous fermentation has been driven by the increased production of monoclonal antibodies says GEA, with Asia-Pacific the new growth driver for such technologies.
in-Pharmatechnologist.com is live from Nuremberg to bring you the best from TechnoPharm and POWTECH 2014, Europe's largest processing and powder shows.
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.
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.
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 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 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.
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.
Drug delivery experts say fixed dose combination (FDC) products for non-oral forms can benefit both the manufacturer and the patient.
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.
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.
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.
[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:
A new tableting excipient eliminates the need for wet granulation and saves up to 60% on overall manufacturing costs according to developer Dow.
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.
French CMO Novasep has received the thumbs up from US regulators at two of its European API manufacturing facilities.
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.
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 has announced two new softgel solutions as it adds greater versatility to its Advanced Technologies Business Unit.
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.
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.
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 says its Xcelodose Precision Powder Micro-Dosing System can shorten drug development time by up to six months.
Over the last decade single-use technologies have moved into manufacturing scales and are increasingly being deployed worldwide, according to Thermo Fisher Scientific.
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.
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 says its new chromatography tech can help manufacturers avoid compromising their processes when switching from multi-use to single use
Single-use is set to dominate biopharma processing as products become more potent resulting in smaller volumes, according to ATMI.
In the war against counterfeits, regulators have concentrated on serialisation and ePedigree and missed an opportunity on product authentication, according to AlpVision.
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.
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.
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 says tableting-focused research project will save customers time and money.
Almac says $10m investment at its recently expanded facility in Northern Ireland compliments the sites existing formulation development capabilities.
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.
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.
Pharmaceutical conferences are like buses - to paraphrase an old British joke - you wait for one and then three come along at once.
So, look. Interphex is a great trade show. No doubt.
Powder Systems Limited (PSL) says the low OEL achieved by its redesigned containment technologies meet demands of HPAPI focused drug industry.
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.
Pharmas should use lower API and excipient volumes if seeking authorisation under the EU Paediatric Investigation Plan (PIP) says the EMA.
Xcelience is shopping for a European distributor after opening a new clinical trial supply facility in the US.
Catalent says making its technology available to industry will not affect its competitive edge.
Using the same equipment from R&D to scale up will cut costs, time and improve efficiency, according to GSK.
Catalent has established a new institute in a bid to advance drug delivery by creating links between industry and academia.
Capsugel has expanded its Licaps liquid fill capsule line with a new facility in the US.
Bend Research is “actively” hunting new partnerships similar to its recent alliance with Dow.
Make information about generic production readily available when working with vendors in emerging markets for quicker US approval, says the FDA.
Manufacturers trying to prove the similarity of their biosimilars must consider that regulations and reference medicines differ in different markets says Pfizer.
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.
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.
The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is largely unmet, according to Aesica.
CMO Cobra Biologics says North America is an obvious place to look at for a facility acquisition.
Ukraine hopes changes to import laws will help cut trial start-up time from six month to 45 days.
Penn Pharma is in talks with a number of “big players” over its upcoming high containment oral solid dose facility.
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 regulations should not change to suit Western GMP standards, according to the country’s Deputy Drug Controller.
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 says it is seeing a flight to quality as pharmaceutical fine chemical customers begin to return to western suppliers.
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 between Western regulators would help ensure a safe API supply chain, according to the EFCG.
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’ as a preparation for cleaning the stand-in-place tech used to produce HP compounds, says Bosh’s Johannes Rauschnabel.
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 Packaging says it is now developing a big batch version of its new X-ray capsule inspection tech.
Sartorius Stedim says its new range of sterilising-grade filters can allow steam cleaning in dry conditions and minimises protein binding.
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.
Safety, efficiency, innovation and single-use tech are the buzz words at Achema 2012 in Frankfurt.
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 says its new non-destructive testing technology is uniquely positioned to help manufacturers reduce waste and save time and money.
Patheon has launched a new consulting service designed to give emerging biotechs and pharmas a boost in their drug development efforts.
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.
Reduce changeover time on oral solid dose machinery by cleaning equipment offline, Fette Compacting urged drugsmakers at this year’s Interphex.
Increased oversight by the FDA is causing some US-based CMOs to shut down, a speaker at Interphex said.
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.
“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.
The need for novel delivery technologies is greater than ever as firms scramble to extract maximum value from drugs, an Interphex speaker said.
Advancements in single-use equipment are crucial to the development of the biotechnology industry, according to experts at this year’s Interphex.
SGS has added formulation development to its service offering through the expansion of its laboratory in Illinois.
Modular plants are the “harbinger of change” in drug production and will allow for more flexible facility construction, a speaker at Interphex said.
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.
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.
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 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 says healthy level of demand for processing technology demos at its recently opened service centre is an indication of processing tech market recovery.
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.
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.
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.
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 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.
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 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.
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.
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
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.
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.
Updating monographs, changing elemental impurity tests and globalisation were discussed by the USP at its workshop and in interviews with in-PharmaTechnologist.
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.
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.
Demand for high-end capsule filling technologies, particularly those used for early clinical development projects, has increased in 2010 according to Capsugel.
Aluminium lakes and in-liner packaging can, in some cases, be used to control reactive components in excipients and therefore overcome drug product instability.
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.
Poor recruitment practices cost the United States pharmaceutical industry millions of dollars, warns a leading US biopharma recruitment agency.
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.
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 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
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.
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.