Floor fillers, day 1 — the latest from CPhI WW’s show floor

Here, we reveal some of the news, developments and product innovations that have been released from the show floor of day 1 of this year’s CPhI Worldwide congress in Frankfurt.

High purity focus

During this year’s show, the Croda team is available to discuss its high purity pharmaceutical excipients and the benefits they provide for multiple drug administration routes.

Sales, marketing and technical experts are on hand at the company’s booth to showcase the range of speciality ingredients via live demonstrations as well as product samples and literature.

Visitors to the booth can learn more about improved API stability, reduced cellular irritation, increased API delivery, accelerated speed to market, reducing drug development times and simplifying formulations.

Hall: 10.2

Booth: 102B11

Website: www.crodahealthcare.com

Excipient solutions

At this year’s CPhI Worldwide event, Dow Pharma Solutions is sharing its latest excipient solutions to address the challenges facing its customers in pharma applications, drug delivery systems and productivity enhancement.

The company’s solutions now include products that are based on the heritage Dow Corning silicone technology platform and are being displayed at the booth. The team from Dow are available to discuss Dow Corning topical excipients, Dow Corning innovative range of topical ingredients as well as productivity and solubility enhancement polymers.

“We constantly seek new ways to push our technologies to the next level and provide even better drug delivery performance for our customers,” states Dago Caceres, global market leader. “AFFINISOL is just one example of how we provide customised solutions to meet growing industry needs like solubility enhancement.”

Additionally, Dow are showcasing its range of biopharma processing solutions for platinum-catalysed pharma tubing and over-molded assemblies. Both are designed to meet the stringent performance and regulatory requirements of biopharmaceutical processes for fluids transportation in various upstream and downstream steps. This technology is particularly crucial during the final filling step where the highly valuable final drug product is in direct contact with silicone tubing.

“Our presence at CPhI reinforces Dow’s commitment to the growth of the bio-pharmaceutical industry with solutions that perfectly fit to critical biopharma processes where component purity is key,” adds Jennifer Gemo, global segment leader for Dow BioPharma Processing.

Hall: 10.2

Booth: 102A50

Website: www.dowpharmasolutions.com

Pathway to first-in-human milestones

Recipharm, a contract development and manufacturing organisation, and Clinical Trials Consultants (CTC), a contract research organisation (CRO), are partnering to launch a service that delivers a clear, streamlined pathway to first-in-human milestones.

This integrated service will be called ‘Recipharm Pathway to Clinic’ and will take projects from early phase formulation development through to clinical trial implementation with patients. Companies of all sizes can benefit from this service to generate data and build value in their compound.

“Our customers often face problems in terms of meeting timelines, adhering to changing regulations and managing trial complexity and it is our job to guide them through the process. Quite simply, Recipharm’s Pathway to Clinic service means we take responsibility for the full Phase I programme, from formulation to clinical trial implementation with patients,” explains Torkel Gren, general manager at Recipharm in Solna. “Managing the different aspects of phase I, while reducing risk, time and cost, requires a clear roadmap and close collaboration between the different disciplines. Through partnering with CTC, we have complete control over all the links in the chain so can adjust at each step to avoid delays, meet deadlines and build value for our customers.”

Anders Millerhovf, CEO at CTC, adds: “Progressing a drug to achieve first in human results is a complex process. Together with Recipharm, we can offer a complete integrated service where all the parts have been optimised to give our customers a fast and cost-effective development program until proof of concept.”

Hall: 4.1

Booth: 41K10

Website: www.recipharm.com

Capsules, films & foils

ACG’s Films & Foils business is launching its new range of products at CPhI Worldwide — Child Resistant and Senior Friendly foils.

The Child Resistant foil is designed to provide a tighter peel barrier and in contrast the Senior Friendly foil is designed for easy peeling. Additionally, the company’s all-inclusive range of films include a variety of aluminium foil solutions and speciality packaging films for different applications.

A wide range of HPMC capsules are on display at the booth, including standard capsules, capsules without gelling agent, capsules for liquid filling and capsules for dry powder inhalation. All capsules are designed to meet the functional, cultural and dietary preferences of consumers.

Furthermore, the company offers other capsule variants, such as hard gelatine capsules, pre-printed capsules, capsules with shiny pearl finish and capsules for clinical trial use, which are also on display at the ACG booth.

Hall: 10.2

Booth: 102D10

Website: www.acg-pharmapack.com

Showcasing operations

Swiss pharmaceutical group, Helsinn, is showcasing operations at its Advanced Synthesis manufacturing facilities where the company develops and manufactures APIs, active ingredients, high potency APIs and most recently, anticancer compounds.

The Swiss facility is cGMP certified and fully compliant with global regulations established by the national health regulatory authorities. Its operations also include business development for third party contract manufacturing.

In addition, at its pharmaceutical corner, Helsinn Healthcare provides an overview of its In and Out Licensing business related to finished products. The Out Licensing opportunities available are presented along with new In Licensing opportunities that can create meaningful synergies with the focus in cancer care.

Hall: 6.1

Booth: 61B20

Website: www.helsinn.com

Automatic vial loading & unloading

Telstar is introducing a new automatic vial loading and unloading system for GMP freeze-dryers, which integrates a steam-sterilisable slider with no concealed parts that moves using a contact-free magnetic drive mechanism, Lyogistics Zero.

As the device or ‘slider’ remains inside the chamber it can be cleaned and sterilised in place with the internal part of the freeze dryer. Without mechanical links between the drive and the slider, the system is able to slide smoothly, maintaining the integrity of the freeze-drying process and product under fully aseptic conditions.

Lyogistics Zero is suitable for use in production processes involving hazardous products and can be integrated within aseptic isolators requiring high level of protection for the operator, the product and the environment.

Hall: 4.0

Booth: 40J30

Website: www.telstar-lifesciences.com

New company launch

A new early-phase contract development and manufacturing organisation (CDMO), Ardena, launches following the merger of Pharmavize and Crystallics and is exhibiting for the first time at CPhI Worldwide.

Ardena will deliver integrated services that include a.o. solid-state chemistry, analytical and formulation development, and early-phase clinical supply manufacturing.

“We made the decision to combine the specialist capabilities of both Pharmavize and Crystallics last year so that we would be better placed to help our customers navigate the hurdles and pitfalls of early phase drug development,” comments Harry Christiaens CEO of Ardena. “The launch of Ardena as a new brand is the next step in this journey and solidifies our collaboration; we are now one company, operating under one name. Looking to the future, we plan to continue this ‘buy and build’ strategy to further strengthen our service offering to customers. New acquisitions will follow soon.”

The new company will be headquartered in Belgium with another facility located in the Netherlands. It specialises in bioavailability enhancement and modified drug release and will take a dossier-centric approach to drug development.

“Drug developers need clinical materials on time in order to generate valuable clinical data and reach their next milestone, yet many face formulation challenges or lack the in-house infrastructure or regulatory knowledge required. Quite simply, our focus is to create strong formulations and regulatory-compliant drug products for clients planning early phase clinical trials,” Christiaens continues. “With product and dossier developed together, quality and regulatory compliance can be ensured from the start of a project. With drug developers under increasing time and cost pressures, this helps to streamline the drug’s progress to clinic and eventually to commercial production.”

Hall: 4.0

Booth: 40B12

Website: http://ardena.com

Livingston facility opening

Eurofins, a bioanalytical testing company, is announcing the opening of a new pharmaceutical chemistry and microbiology facility in Livingston, Scotland, following its £4 million investment.

The new facility will be a dedicated testing site and will enable the Biopharmaceutical Product Testing (BPT) UK business to expand its finished product and raw materials testing as well as increase capacity to deal with higher volumes. The BPT plans to double its number of employees over the next five years.

Additionally, GMP microbiology contract testing will also be a focus, alongside elemental impurity testing. Eurofins is also looking to invest in more high-performance liquid chromatography (HPLC) equipment, increasing its capacity by 40%.

“The large investment in the facility will position the company in the best place to attract new customers thanks to greatly increased capacity, and is in line with Eurofins’ intent to attract significant future growth and development opportunities,” adds Alison Clayton, general manager of the Livingston site.

Eurofins BPT UK business will move from its current site in Newbridge, Edinburgh. The Livingston facility will also house new laboratories for Eurofins’ water testing business.

Hall: 4.0

Booth: 40D30

Website: www.eurofins.com