Tesa Labtec GmbH

Langenfeld, 
Germany
http://www.tesa-labtec.com
  • Booth: 3028

tesa Labtec offers the development and manufacture of film shaped dosage forms (CDMO services) like transdermal and topical patches as well as oral, buccal or sublingual films. The business activities comprise formulation development, scale up and manufacture of clinical trial supplies or finished products under full cGMP conditions. Thereby tesa counts on its proprietary technologies Transfilm®, Rapidfilm® and Mucofilm®. tesa Labtec is a wholly owned subsidiary of tesa SE, a member of the Beiersdorf group of companies, and offers its services to customer worldwide. Our sites in Langenfeld and Hamburg are FDA approved.


 Products

  • Mucofilm®
    Our coated, ultra-thin Mucofilm® allows a persistent adhesion to the mucosa that enables transmucosal drug delivery. Great advantages for patients and pharmaceutical companies result in an excellent opportunity for drug delivery....

  • Buccal films are placed on the inside of the cheek enabling (local or) systemic drug delivery. Our Mucofilm® technology creates a thin mucoadhesive film that enables transmucosal drug permeation.Buccal delivery of drugs offers several advantages compared to tablets, for example. The drug becomes systemically available by direct uptake through the mucosa. The result is an almost immediate onset of action and prompt relief. Less metabolites due to reduced first-pass effect. This allows for a marked reduction of the applied dose and causes fewer side effects. Our Mucofilm® technology opens up completely new possibilities for molecules with low bioavailability.

    tesa Labtec is able to design buccal films with single or multiple layers in varying thicknesses that can incorporate different actives. By specifically modifying the design of the carrier, the drug can be unidirectionally released to the buccal mucosa, both for local or systemic uptake, or into the oral cavity for local action. tesa Labtec’s buccal systems exhibit mucoadhesive properties upon contact with saliva, resulting in secure adhesion to the application site. Mucofilm® can be designed to either dissolve or to remain in its original form.

  • Transfilm®
    tesa Labtec is specialised in the development of different types of patches. Using our Transfilm® technology we can develop topical, transdermal as well as buccal patches....

  • A transdermal patch or transdermal system (TDS) is a medicated adhesive patch that is placed on the skin to deliver a specific dose of drug through the skin and into the bloodstream.

    The fact that transdermal patches can provide a controlled release of medication from 24 hours up to seven days gives it a major advantage over other types of drug delivery, such as oral or other types of topical administration (for example, gels or creams).

    The delivery of a drug via a transdermal route of application offers the best of oral and intravenous administration. Avoidance of the first-pass effect leads to better bioavailability and may result in fewer side effects. Consistent and controlled drug delivery can minimize or avoid periods of under- and overdosing. Transdermal patches deliver drugs over a longer period of time, thus allowing for reduced dosing frequency. A transdermal patch is administered by the patients themselves and administration is stopped by removal of the patch. Contrary to intravenous drips or infusion pumps, patient activity is not restricted. These numerous benefits lead to significantly improved patient compliance and as a consequence transdermal patches can offer a critical edge to new and established drugs in competitive markets.

  • Rapidfilm®
    The ultra thin and small films offer various advantages for patients and care givers and can contain many different active ingredients. Our Rapidfilm® can be applied in many therapeutic indications and states the most convenient oral dosage form nowadays....

  • tesa Labtec's Rapidfilm® is an innovative oral dosage form that offers strong advantages to patients and combines the convenience of a liquid with the stability and dosing accuracy of a tablet. We offer this technology accompanied by our development and manufacture expertise to our customers.

    A Rapidfilm® is a very thin film which is applied in the mouth. It is based on water soluble polymers. Our films typically have a size of 3-9 cm2 and provide a thickness between 50 and 500 µm. The design can vary from single to multi layer systems.

    The main advantages of a Rapidfilm® are:

    • Easy application - no swallowing difficulties and therefore high acceptance by elderly and children
    • No beverages necessary for intake
    • The film cannot be spat out
    • Risk of Aspiration reduced
    • Ideal „take-away medicine“
    • Area proportional dosage form allowing for numerous different doses from one base laminate

    The orodispersible Rapidfilm® works like a conventional or orodispersible tablet. The film is placed on the tongue and dissolves within a few seconds. The active ingredient is swallowed together with the saliva and takes the same route as a tablet via the liver where the drug is metabolized.

  • Contract Development
    In a short period of time and in close collaboration with your team, we can explore the feasibility and assess the chances of a full development program. In a timely manner and with full transparency our experts can create an excellent market opportunity....

  • When developing film or patch products we follow a structured approach for each project accompanied by a professional project management.

    Our R&D site in Langenfeld, Germany, is a state-of-the-art facility with modern equipment for professional drug delivery development. The formulation department has direct access to all necessary development tools. Our in vitro testing group routinely performs Franz cell tests. The analytical laboratory can offer a broad range of pharmaceutical testing from method development and validation to long term stability testing for registration purposes. State of the art equipment and modern information technology ensure timely, reproducible results at reasonable costs.

    Integrated quality assurance procedures and full cGMP compliance warrant reliable results. We have the full equipment and personnel qualifications for manufacturing of clinical trial supplies under cGMP conditions. Therefore, our LabFactory is able to provide our customers with CTS for even large phase II studies. 

    Our integrated service includes scale up and tech transfer activities which can also be accomplished in our manufacturing site, located in Hamburg.

  • Contract Manufacturing
    tesa Labtec is prepared to support all of your clinical trials and full scale production needs. State-of-the art manufacturing equipment is available in our plant in Hamburg, Germany....

  • Our plant is dedicated to the manufacture of patches and oral films. The equipment and the operating procedures have been designed to fulfill the strictest legal and regulatory standards including cGMP and AMG (German Drug Act). Furthermore, our facility has been inspected by FDA. Thus, we are able to supply international markets.

    Our coating lines offer variable coating widths between 10 cm and 145 cm. This allows us to perfectly match your volume requirements, from small test quantities up to several hundred millions of units. Depending on our customer’s need we produce bulk or secondary packed products.

    The site offers the manufacture of
    • Clinical Trial Supplies (CTS)
    • Scale up batches
    • Pilot batches
    • Stability batches
    • Routine batches, finished goods
    We are capable of handling controlled substances as well as toxic substances (e.g. nicotine).

    Due to our affiliation to tesa SE we can offer tesa’s international supply chain and engineering capabilities which constitute further advantages for our customers. You can count on our technological expertise and our material know-how to keep tight project timelines and reduce total process cost.
  • FDA Pre-Approval Inspections
    tesa Labtec announces successful completion of FDA Pre-Approval Inspections of its R&D and manufacturing facilities....

  • The German patch and oral thin film maker announces the completion of a Pre-Approval Inspection (PAI) by the US Food and Drug Administration (FDA) in February 2016.

    During a total of 7 days of inspection, FDA visited both, the R&D site in Langenfeld as well as the manufacturing facility in Hamburg, Germany. FDA provided feedback with a short list of observations which tesa Labtec takes seriously. At the concluding sessions of the inspections, the FDA Investigator said that the initial conclusion was to approve the sites for commercial activities. That conclusion must still be reviewed within FDA. tesa Labtec has responded promptly to the observations which the Investigator had raised.

    “This FDA inspection demonstrates a significant milestone within our plan to expand our business to the US market.” stated Dr. Ingo Lehrke, Managing Director of tesa Labtec. “The inspection paves the way to the US market for our customers’ transdermal patches and oral thin films and certifies the high quality of our development and manufacturing capabilities. This achievement was made possible through the dedication of our talented staff.” Dr. Lehrke concluded.

    The PAI was triggered by a customer’s ANDA filing for a transdermal patch, which is manufactured by tesa and is designated for US distribution