So,why Nidacon?

Nidacon understands that the first steps towards successful artificial reproduction are the most important. We do our best to provide the tools and methods to make sure that they are done correctly. Helping our customers help theirs – Right from the start.

Nidacon develops, manufactures, and markets medical devices and solutions for Assisted Reproduction Technologies (ART), including IVF, ICSI, artificial insemination (IUI), and vitrification.

The first steps towards successful artificial reproduction are always the most important. That’s why we at Nidacon do our best to provide our customers with the tools and methods to make sure that they are done correctly. Helping our customers help theirs – Right from the start.

Headquartered in Gothenburg, Sweden, Nidacon is continually striving to improve assisted reproduction outcomes by developing superior media systems for ART clinics and patients as well as the animal breeding industry. Nidacon is:

DR. PAUL HOLMES. MSC, PHD, DRMEDSC, ASSOCIATE PROF.
President
DR. EWA USTYANOWSKA-HOLMES, MD
Executive Medical Director. MD
MAGDA ALIC HOLMES
Vice President
KRISTINA WRIGHT
Financial Coordinator
OSCAR RYMO
Marketing Manager
Anders Edvardsson
IT and Administration Coordinator
Mauricio Lucena
Key Account Manager – Community Manager
Ann-Sofie Forsberg
Product Manager
Anna Niläng
Vetenarian Product Manager
Emma Holmes
Product Manager
Håkan Nilsson
Production Manager
Sean Graham
Purchasing/Production
Christina Jonsson
Production
Marina Danilova
QA
Dennis Johansson
Logistics Coordinator

Quality is
our mission

At Nidacon, our mission is to help improve one of the most important parts of life’s journey – its start. We do this by developing superior products for assisted reproduction applications, doing our best to improve the outcome of Assisted Reproduction with more pregnancies, by developing superior products and systems for clinic and patients. We focus on providing the highest quality care of living cells, both with regard to quality and technical standards. We then make these products globally available to clinics and patients in the human assisted reproduction and animal breeding industries, with the goal of making Nidacon the first choice for both current and future customers.

At Nidacon, both our products and our reputation are built on a foundation of quality. We go to great lengths to ensure maximum quality in everything we do. In production, we achieve this by using only the most carefully selected and evaluated suppliers and seeing to it that our products are of high and consistent quality and meet or exceed all regulatory requirements for the medical device companies we supply. Our devotion to quality doesn’t stop there, however. We are also committed to continually investing in the further development and extension of our product portfolio in order to remain a financially stable and growing company both now and in the future.

The Nidacon Approach to Quality Assurance

In order to ensure that we consistently meet the highest of possible standards, Nidacon practices a strict approach to Quality Assurance (QA). We check every product or process to ensure the following:

  • That every product is registered with the applicable agencies and meets the directives and requirements for each country.
  • That every production batch is carefully tested at Nidacon, with sterility controls, endotoxin level measurement, biological efficacy tests, and more being carried out before any product is released to the market.
  • That each production batch will be accompanied by a quality assurance certificate which records the results of the tests that Nidacon has performed.
  • That our management system enables and secures continued organizational development with regard to Quality Control and Assurance.

Knowing that we adhere to these stringent guidelines enables customers to be secure in the knowledge that when used correctly our products will provide the most reliable and highest quality results possible.

Mission, Vision, and Quality Control Statements

Business Mission

Our mission is to improve life’s journey by developing products for care of living cells. Our products superior both in quality and technically shall be made available to clinics, patients and the animal breeding industry worldwide. 

Vision

We shall be the natural choice for customers, thanks to our service and products.

Quality Policy

We shall through a global, open and flexible dialogue with the market optimize our work with our existing and potential marketing channels. We shall have high quality productions with carefully selected and evaluated suppliers. We shall fulfil the regulatory requirements for medical device companies with the products we offer. We shall be outstanding when it comes to high and consistent quality on our products with a focus on further development and broadening of the portfolio. We shall be a financially stable and growing company which offers our co-workers and attractive and prosperous working place where we can develop and take responsibility.

Right From the Start Starts with Comprehensive Testing

Each and every product that Nidacon ships must pass very rigorous testing before bearing the Nidacon label. The tests we run are preformed to the highest standards and include:

Physical Analyses

pH Testing: – the pH of every batch is tested both during production and at room temperature after the product is bottled.

Osmolality: – the concentration of dissolved particles of chemicals and minerals in each batch is tested both during production and after.

Sterility and Toxin Analyses

Microbiological Growth Control: – bacterial and fungal growth assays are performed over a period of 2-3 weeks after each batch is produced in order to detect any microbiological growth. These assays are done by the Bacteriological Laboratory of Sahlgrenska University Hospital, Gothenburg, Sweden, a highly accredited, independent state laboratory.

Endotoxin Detection: – this assay is done with an FDA-approved, Limulus Amoebocyte Lysate (LAL) test using a quantitative spectrophotometric method in order to obtain real EU/mL values in accordance with the U.S. Pharmacopoeia. The test is carried out by the accredited laboratory of the Microbiology Institute at the Sahlgrenska University Hospital of Gothenburg, Sweden.

Biological analyses

Human Sperm Test: –we use both subjective testing and computer assisted sperm analysis (done at Micans by Embryotools) to assess sperm yield, motility, and viability. Each batch is tested using human semen samples. The samples are separated into two parts, one used for control and the other for batch preparation. The test-batch results are compared with the results from the control and provide a count of the sperm per mL. Sperm activity is also graded and expressed as a percentage of the total sperm. All data are recorded both before and after separation and purification, and are compared to the already approved control batch.

Human Sperm Survival test: – prepared sperm are covered with oil and incubated overnight in 37°C, 5-6% CO². Percentage of motile sperm is measured on day 2.

Mouse Embryo Assay (MEA): – this test is used to assess pre-implantation embryo in vitro growth and development when exposed to the test item. The assay predicts embryo toxicities in medical devices or related products used in assisted reproductive technology (ART).

Mouse Embryo IVF Assay for Media: – a sensitive assay mimicking the human IVF procedure. The preferred assay to screen assisted reproductive technology supplies for toxicities impairing male and female gamete fecundability and subsequent embryo development capacity. All tests are done by Embryotools, a contract research laboratory specialised in the analysis of the reproductive function.

Peroxide Analyses: – the peroxide level is measured using a QuantiChrom™ Peroxide Assay. The improved method utilises the chromogenic Fe3+-xylenol orange reaction, in which a purple complex is formed when Fe2+ provided in the reagent is oxidised to Fe3+ by peroxidise present in the sample.

Functional Analysis/ Efficacy Test: – used to prove the efficacy and function of the products.

Visual Control: – constant visual control during production, filling, labelling and final control of chosen ready packages.

 

 

At Nidacon, we take Corporate Social Responsibility seriously.

We vow to do our best to help create and maintain a sustainable world, not just by adhering to the strictest environmental policies with regard to our products and production, but by taking responsibility for our impact on society as a whole. We will always strive to contribute in the best way we can to improve the world around is, both at home and abroad. After all, what point is there in helping to create new life if our world is not a sustainable place to live in?

Every journey begins with  a single step.

In ecology, as in life, sustainability is the capacity to endure. Achieving sustainability is how biological systems remain diverse and productive indefinitely. In the natural world, reaching this stage is the result of long evolutionary processes. When it comes to human society, however, we do not have the luxury of time. We must fast-track our evolution if we are to leave a liveable world behind. This process, like any other, consists of many small steps, each important, but none so important as the first – the courage and willpower to begin.

Societal sustainability is focused on sustainable development, which covers four distinct areas: ecology, economics, politics, and culture. At Nidacon, we do our best to operate in each of these areas in the most sustainable way possible. These efforts include:

Recycling

At Nidacon, we think a lot about our legacy. That’s why we take responsibility for our impact on our world and work actively to ensure that our legacy is a positive one. The first step in this process is a more conscious use of our finite resources. Having a well-functioning system for waste recycling is essential to maintaining healthy ecosystems and environments.

Carbon offsets

Most of modern life – such as producing and transporting products, driving, and heating buildings – involves consuming energy and producing carbon emissions.

A Carbon Offset is a way to compensate for carbon emissions by funding an equivalent carbon dioxide saving elsewhere. Nidacon transport products all over the world, and while we use the most practical and sustainable forms of transport available, we compensate for the carbon emissions caused by these transports by supporting carbon emissions reduction projects, helping to mitigate our environmental impact.

Supporting street children of Nepal

Nidacon’s entire business is helping couples fulfil their dreams of having a family. For this reason, we feel that we have an extra responsibility for the children in the world. We put a great deal of effort into selecting the organizations/projects we support, and are pleased to be working with the “We Care” organization in this regard. The organization has three ongoing projects focused on helping “street children” in Nepal, focusing on improving the lives of these at-risk children and hopefully providing a better future. Click here for their latest newsletter.

We are always open to tips and suggestions as to worthwhile charitable organisations. Please do not hesitate to get in touch with your thoughts!

Spreading knowledge

To be a good sustainability ambassador requires keeping updated on the most relevant data and thinking. To ensure our continual development, Nidacon attends seminars, courses, and conferences with this in mind. We are proud, for instance, to be a member of CSR West Sweden, an organization which focuses on global sustainability in all the four interconnected areas mentioned above. CSR West Sweden helps organizations attain more sustainable practices, partially through interesting and informative seminars (such as a recent one based on KPMG’s study on Global sustainability “Megaforces”). You can read more about the organization and what they do here:

csrvastsverige.se

Biodiversity efforts

The variety of all life on our planet – biodiversity – is vital to sustainability. Biodiversity also provides a significant amount of economic, environmental, health, and cultural benefits to our society, from raw materials and medicines to richer Ecco systems and jobs. Unfortunately, biodiversity is on the decline. One example is the reduction in the number of honeybees and other pollinators, which now are becoming endangered species. This is especially dangerous since bees play a critical role in our ecosystem, with the majority of all plants and about one third of the world’s crops, requiring cross-pollination to reproduce and thrive. For this reason, part of Nidacon’s sustainability efforts are focused on helping to prevent further reduction of the honeybee population, thereby increasing in biodiversity and pollination in our local ecosystem.

It’s all about the birds and the bees (especially the bees)

Nidacon is thrilled to welcome 30,000 new employees to our family! These new additions – the residents of the new beehive in our backyard who joined us in May 2019 – seem to have settled in very nicely and are already hard at work.

Our foray into beekeeping began with a partnership with Beepartners, an organisation that provides pollination possibilities in urban environments. Andrés Amaya Briñez, who started Beepartners, and his wife Diana maintain the hive, but all Nidacon employees are welcome to join in checking on the bees – as well as enjoying the honey they produce, of course!

PUREHONEY 100

The colour and taste of the honey depends on where the bees have harvested pollen and from that type of flowers. Nidacon bees produced around 25kg of golden brown, rich tasting honey last year. The honey we harvest is packaged as PureHoney 100, but some honey is always left in the beehive, providing food for the bees during the long, cold and dark Gothenburg winters. In addition to producing honey, these hard-working honeybees are securing the reproduction of the local flora around the company, thereby playing a crucial role in preserving biodiversity.

 

Bee facts:
  • A bee can fly up to three kilometres from the hive to collect pollen and nectar
  • Bees eat pollen and nectar. Nectar is energy rich, and pollen is a kind of protein which is needed for the brood (eggs, larvae and pupae) to grow and become bees.
  • One beehive can produce 30-50 kg honey/year.
  • Temperature in the beehive is kept around 20°C by the bees themselves, regardless of the outside temperature. When the temperature outside rises to about 10°C, bees emerge to once again start collecting and producing.
  • Honeybee queen – the most important bee in the hive. She is responsible for the reproduction of the bees.
  • Drones – male bees They are responsible for fertilizing the queen
  • Worker bees – female bees without full reproductive capacity. They have many working tasks, such as collecting pollen, nectar and water, cleaning, guarding the hive, honeycomb building, etc.