Showing posts with label hyaluronic acid. Show all posts
Showing posts with label hyaluronic acid. Show all posts

Friday, 11 May 2012

Novozymes starts commercial supply of new and improved hyaluronic acid from Q7 cGMP facility

Novozymes has started supplying Hyasis®, a novel pharmaceutical grade hyaluronic acid, from its newly opened Q7 cGMP facility. Hyasis sets a new standard for hyaluronic acid offering unprecedented safety, consistency and performance.


NOTTINGHAM, UK – May 9, 2012 – Novozymes Biopharma, part of Novozymes A/S, the world leader in bioinnovation, has announced the first shipment of the company’s Bacillus-derived hyaluronic acid, Hyasis®, from its newly inaugurated manufacturing facility in China, which represents an investment of more than DKK 350 million. The first commercial products using Hyasis as a raw material are expected to reach the market in Q2 of this year.

“Shipment of the first commercial hyaluronic acid material from our new Q7 GMP facility marks an important milestone on our journey to becoming a leading producer of high quality hyaluronic acid. With our new patented process, based on the safe bacteria Bacillus subtilis, the market will have access to a new improved source of HA which is fully compliant with the highest pharmaceutical standards and developed with customers’ specific needs in mind”, says Thomas Videbæk, Executive Vice President of Novozymes A/S.

Hyasis has been specifically designed to fill a gap in the market for biomedical and pharmaceutical manufacturers looking for Q7 regulatory compliant ingredients with superior performance benefits.

“Improving how our customers can process and formulate HA for medical applications has been the key driver in the development of Novozymes’ new patented HA production process and facility”, comments Hans Ole Klingenberg, Global Marketing Director at Novozymes. “Our unique technology will expand opportunities in the pharmaceutical and biomedical industries across multiple applications for HA, creating improved therapeutic treatments with real benefits for both manufacturers and patients.”

Novozymes’ focus on improving processes for its customers has resulted in a hyaluronic acid that offers a wealth of innovative advantages over competitive sources. Superior heat stability permits autoclaving without significant loss of product viscosity, and tight control of molecular weight during production allows for excellent control in formulations. Novozymes’ Hyasis also offers its customers unmatched batch-to-batch consistency in production at large-scale, and the capability of the product to dissolve five times faster than other sources can reduce processing times by up to 50%.

“We believe we have a very strong offering for the medical device and pharmaceutical markets. Not only is Hyasis manufactured in accordance with requirements for an active pharmaceutical ingredient, it also offers unrivalled safety, consistency and performance to the benefit of our customers and partners. In addition, customers will have access to our dedicated team of researchers who can help them solve their formulation problems, resulting in time and cost savings, manufacturing processes improvement and safer and more efficient treatments for patients. In this way, we are setting a whole new standard in the market and redefining the use of hyaluronic acid”, says Thomas Videbæk.

A critical component in the development of an improved biomedical grade HA has been the construction of the new manufacturing facility designed exclusively for Hyasis. Located in Tianjin, China, the facility employs a patented water-based process to manufacture Hyasis to Q7 cGMP standards. Working with raw materials that are already Q7 compliant can help medical device and pharmaceutical drug manufacturers to reduce testing time, minimize documentation requirements, save on manufacturing costs and take products to market faster.

First customers have been testing the product for some time with good results and Hyasis is now being sold to medical device and pharmaceutical customers. Thomas Videbæk says, “The market for pharmaceutical use of hyaluronic acid is estimated to have a size of DKK 1 billion. With regulations in the medical industry getting tougher and tougher, we believe we are well positioned in Novozymes to offer customers an improved source of hyaluronic acid that will comply with their long term needs – and with our long term investment in this new facility we aim to play a leading role in the market for hyaluronic acid for many years to come.”

For further information on Novozymes’ Hyasis, Bacillus-derived hyaluronic acid, please visit www.hyasis.com.

About Novozymes

Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries, we create tomorrow’s industrial biosolutions, improving our customers' business and the use of our planet's resources.

With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace. Read more at www.novozymes.com.


Thursday, 13 October 2011

Novozymes to showcase state of the art cGMP-grade hyaluronic acid (HA) at CPhI 2011

HA designed specifically to fill a gap in the market for medical device and pharmaceutical manufacturers looking for Q7 cGMP regulatory compliant ingredients with superior performance benefits.
NOTTINGHAM, UK – October 13, 2011 – Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, will showcase its soon to be launched state of the art Q7 cGMP-grade hyaluronic acid (HA) at CPhI Worldwide 2011. The new Bacillus-derived HA has been developed to improve how customers process and formulate HA for medical device and pharmaceutical applications, helping to speed up product development and creating improved therapeutics. The product confers a range of unique performance advantages for medical devices, drug delivery and formulation and will be showcased on booth #42H55 in hall 4.2 at the Messe Frankfurt, October 25-27, in Frankfurt, Germany.

“Novozymes is delighted to be returning to CPhI to showcase the company’s soon to be launched Q7 cGMP HA”, comments Hans Ole Klingenberg, global marketing director at Novozymes. “Delegates will be able to see the HA and our team of experts will be on hand to provide insight into how it can be incorporated into their manufacturing processes to reduce testing time, save on manufacturing costs and take products to market faster.”

Novozymes’ HA has been developed to expand opportunities for HA across multiple applications in the pharmaceutical and medical device industries. Produced at Novozymes’ new facility in Tianjin, China, which has been designed exclusively for HA, the company uses a patented water based process which is run in compliance with ICH Q7 cGMP guidelines. The resulting HA is free of animal derived components and organic solvents, resulting in a high degree of purity and reduced risk of contamination. It offers high batch-to-batch consistency with tight control of molecular weight for improved formulation control, as well as the capability to dissolve up to five times faster than other commercially available sources of HA. In addition, superior heat stability permits autoclaving without significant loss of product viscosity.

The new HA can be customized further using Novozymes’ proprietary crosslinking technology to achieve a specified viscosity, allowing the product to be adapted for a range of drug delivery and medical device applications. From ophthalmology and dermal filling to osteoarthritis treatments and cancer treatment, the unique technology will assist customers to create improved therapeutics with real benefits for both manufacturers and patients.

Novozymes’ HA will be commercially available in December.

To learn more about Novozymes’ HA, please visit booth #42H55 in hall 4.2 at CPhI Worldwide 2011. Alternatively, please visit www.biopharma.novozymes.com.

About Novozymes
Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries, we create tomorrow’s industrial biosolutions, improving our customers' business and the use of our planet's resources.

With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace. Read more at www.novozymes.com.

Thursday, 19 May 2011

Novozymes Biopharma to showcase hyaluronic acid for ophthalmology applications at Joint Congress of SOE and AAO 2011

New recombinant hyaluronic acid for eye care and ophthalmic drug delivery.
Study results to be presented at the 2011 Joint Congress of SOE and AAO.

NOTTINGHAM, UK – May 17, 2011 – Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, today announced that it will be showcasing its hyaluronic acid (HA) product for eye care and ophthalmic drug delivery at the 2011 Joint Congress of the European Society of Ophthalmology (SOE) and American Academy of Ophthalmology (AAO), which will take place from June
4-7 2011 in Geneva, Switzerland. Novozymes will also be presenting its latest scientific poster at the show, highlighting the results of the company’s recent study into the use of HA for ophthalmic formulation. For more information on Novozymes’ HA or to request a copy of the scientific poster, please visit booth #1256 at the Joint Congress of SOE and AAO 2011 or www.biopharma.novozymes.com.

“We are proud to showcase our innovative HA product which, due to its high purity and biocompatibility is ideally suited for use in formulations intended for eye care and ophthalmic drug delivery” comments Hans Ole Klingenberg, Global Marketing Director at Novozymes Biopharma. “We are also delighted to present the results of our latest study into the use of HA in ophthalmology, which provides insight into the increasing need for a high purity HA ingredient for ophthalmic applications.”