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Contact: Javier Berterreche, M.Sc. Job title: Business Development Mngr Company: Bioinicia Contact: contact@bioinicia.com Visit us: www.bioinicia.com
1What are three factors you encourage brands to ask about to help them select the ideal manufacturing partner?
What kind of problems is your partner solving? Does your partner technology offer specific advantages over other available options? What added value does your partner deliver to you and to your product? We, at Bioinicia, can provide unique solutions in the field of drying and microencapsulation of heat sensitive bioactives, using electrohydrodynamic atomisation (EHDA), with our patented technology CAPSULTEK ®, at room temperature and in one single step. Bioinicia is a global leader in this technology, with the world first food- and pharma-grade, large-scale GMP and ISO certified plant. With our broad experience and strong IP and experience, we are ready to become the ideal manufacturing partner for food & nutraceuticals companies in this field.
2What services and capabilities do you provide to brands looking to launch a product to market?
As a Contract Development and Manufacturing Organization (CDMO), we offer a strategic partnership from concept to final product, providing full support in each stage of the projects and working side-by-side with our partners in order to fulfil their needs. We have developed CAPSULTEK®, an innovative method for the encapsulation of thermo-labile compounds at room temperature, merging encapsulation and drying in a single stage. This allows to produce improved functional foods and supplements with high concentration of active ingredients from natural sources and to prevent their oxidation and degradation.
Besides this, we can efficiently mask off flavors that could impair the acceptability of the food application. CAPSULTEK® technology can process any type of bioactive compound for the food & nutraceuticals sector due to its excellent process control and conditions: vitamins, antioxidants, minerals, essential oils, phenolic and bioflavonoid natural extracts, PUFAs, probiotics, etc. Besides our development and manufacturing services, we can also offer the licensing of the technology and our engineering services for the design and commissioning of the equipment.
3What measures does your company have in place to achieve high quality and compliant production?
Bioinicia has been world first company awarded with GMP certification for electrohydrodynamic technology facilities to manufacture pharma products. You can leverage the expertise of the leader! We work under strict food & pharma GMP standards, with our own in-house production, analytics, and quality control facilities.
4How do you define your company’s value proposition as a manufacturing partner?
We offer a disruptive technology for drying and microencapsulation of sensitive products, at room temperature and in one single process step, working together with our partners to solve their product stability problems, improving shelf life and bioavailability, from the concept to the final product. Optimized performance, low impact, and simplicity are the core of our value proposition.
Contact: Kristina Edvinsson Job title: General Manager and Owner Company: Gelpell AG Contact: info@gelpell.com Visit us: www.gelpell.com
First you should ask yourself which services will you require to launch your product, will you be needing several manufacturers or services or are you looking for a full service provider from sourcing the raw ingredients to encapsulation to ready to sell packaging? I then recommend a first contact via mail in which you present your company and the expectations in a cooperation. At this stage, you should evaluate how competent and quick the responds rate is. Secondly getting to know each other in a personal meeting at a trade show like Vitafoods or Video call is a great way to ask questions regarding their in-house capabilities, certificates acquired, quality control measures, delivery times and development capabilities. Thirdly, I feel you need to be convinced that you have found an honest, capable and reliable partner you can trust.
For over 15 years, the name Gelpell AG has stood for high-quality capsules as well as formula processing and the packaging of food supplements and nutrients. Our owner-operated company is based in the Swiss town of Gähwil, south of Lake Constance. From here, we supply partners worldwide quickly and reliably. Being the fourth generation of entrepreneurs, dedicated to the field of contract manufacturing as well as human health and nutrition we have built a know-how and competence that is unique to the market. We do not only understand the production side but also the issues and difficulties that our clients encounter and are diligently working on optimising your customer experience by providing an excellent customer service and products of highest quality. We have an in-house development team that is here to help you develop or optimise your product to stay with the newest regulatory conformity as well as trends. Our services include:
Nutritional supplements and pharmaceuticals are subject to high quality standards. As a company that produces exclusively in-house and in Switzerland, we can monitor all process steps, from incoming goods to the finished product. We offer comprehensive quality management and continuous quality controls. We carry out test procedures in accordance with Ph. Eur. and food guidelines, and our registrations prove our high FDA, ISO, Swissmedic, Organic, Halal and medical products quality. Our production meets the high requirements of Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Points (HACCP).
My Husband Tomas and I see Gelpell as a high quality solution and a flexible service partner with a great focus on our customers. We are very aware of the trust that is put into a contract manufacturer. Therefore, we have decided to provide all services that the customer may require in house in Gähwil. By this measurement, we can guarantee the highest quality control possible. From the beginning of the process by qualifying and evaluating our raw ingredient suppliers, development, production and packaging, we can guarantee you a speedy, flexible and high quality service that is unique to the market in Europe. We have a high competence in developing sensible products, which meet European conformity. Providing an excellent value proposition at a competitive price. In many occasions we have also transferred products with perfect results, our high customer loyalty are a testimonial to the service we offer.
Contact: Andrea Taborelli Job title: Business Development & Licensing Manager Company: IBSA Contact: Business.Development@ibsagroup.com Visit: www.businessdevelopment.ibsagroup.com
1 What are three factors you encourage brands to ask about to help them select the ideal manufacturing partner?
IBSA is the ideal partner to serve other companies in the pharmaceutical and nutraceutical industry thanks to its consolidated experience, industrial capacity and proprietary state-of-the-art technologies, that allows the group to provide comprehensive services from drug development to drug manufacturing for EU and non-EU markets. IBSA is present with its products in over 80 countries in 5 different continents, with 20 subsidiaries, in Europe, China and the United States, and employ 2,000 people in its headquarters, branch offices and manufacturing sites. IBSA holds 82 registered patents and an yearly production of 60 million packs of finished products.
IBSA provides a complete service consisting of: 1. product concept and pre-formulation; 2. formulation and process development; 3. development and validation of the analytical method; 4. pre-clinical investigation; 5. pilot and scale batches; 6. clinical batches; 7. studies and stability test; 8. scientific and regulatory assistance. In particular for nutraceutical market IBSA offers two specific innovations, suitable to satisfy every formulative need:
In order to guarantee the safety of our products and their compliance with quality, environment and health laws and regulations, we conduct continuous internal audits and our manufacturing sites are inspected by the National Regulatory Authorities of the countries (in UE and extra-UE) to which we export our products. Moreover, each manufacturing site is dedicated to specific product ranges, in compliance with the separation of productive processes principle: a strategy that has made it possible to obtain certification by the most stringent regulatory authorities, as demonstrated by the approval of IBSA products in the United States.
A comprehensive and tailored service, the flexibility in dealing with the partner’s needs and the commitment to work side by side with clients are the differentiating points of IBSA’s contract manufacturing offer.
Contact: Kaspar van den Dries Job title: SD of Science and Innovation Company: Thermo Fisher Scientific Contact: pharmaservices@thermofisher.com Visit: www.patheon.com
Launching a new product can be a very exciting—and sometimes daunting—endeavour, and the CDMO market is highly competitive, so we know brands have a choice of who they choose to work with. It’s important to find a partner with the capabilities, flexibility, and long-term vision to support your work every step of the way. When searching for a partner, ask the following:
How will you support my product from the development phase to the commercial phase, and what quality assurances can you provide?
How fast, reliable, and flexible is your supply chain? What processes do you have in place to mitigate supply risks throughout the development process?
What investments in digital offerings and innovations are in the works to further bolster drug development and commercialization?
Of course, we encourage brands to think about their specific needs when considering a new partnership but finding a manufacturing partner that is invested in your success with the capabilities and global network to back it up is crucial.
We are a full-service CDMO with comprehensive end-to-end solutions from molecule to medicine. Our capabilities include discovery research, process development and optimization, GMP manufacturing, clinical trial manufacturing, supply and logistics, and commercial launch. We are a true partner that can help brands:
Create or source an ingredient
Design the ideal formulation
Scale to the next milestone
Develop clinical supply chain strategy
Accelerate clinical research
Deliver a successful commercial launch
We have a “Get it Right the First Time” approach and zero-defects mindset when it comes to quality and compliance. This has helped us achieve a 40% reduction and avoidance of deviations, 90% “right first time” targets, and twice as many NDA approvals than the next largest CDMO. Beyond that, we value innovation and have a well-designed IP protection system in place, as well as robust SOPs, to help ensure success long-term without sacrificing quality.
Backed by the Thermo Fisher Scientific global pharma services network, we are in a unique position to leverage our expertise, end-to-end solutions, capacity, expansive global network, and flexibility to drive projects of any scale forward, whether it’s for emerging biotech firms or large pharmaceutical companies—and everything in between. This includes drug product and biologics development and manufacturing, clinical trials supply chain, packaging, and logistics.