Bio-Works forms distinguished Scientific Advisory Board

Press release September 10, 2018

Bio-Works has recruited four distinguished scientists with industrial experience to its Scientific Advisory Board (SAB). The purpose of the SAB is to bring in qualified advisors for strategic and tactical issues regarding Bio-Works’ technical, product and marketing focus.

During the spring and summer, Bio-Works has recruited the following advisors to its SAB:

Dr. Per Möller has a background as organic chemist in the lab of Nobel Prize laureate Arvid Carlsson. He has more than 35 years experience from the chromatography area including the chromatographic resin business, drug discovery, scaling-up and GMP production of biological pharmaceuticals. Per joined the PolyPeptide Group in 2007 which is world leading in the production of peptides.

Professor Jurgen Hubbuch is the Head of the Institute of Engineering in Life Science at the Karlsruhe Institute of Technology, Germany. Prof. Dr. Hubbuch is a co-founder of GoSilico, a company with focus on in-silico-simulated chromatographic experiments . He has more than 15 years of experience in chemical engineering, biotechnology process development, biomolecular separation and engineering from leading positions at University of Karlsruhe, Germany, Technical University of Denmark and Heinrich-Heine-University Dusseldorf, Germany.

Dr. Stuart Jordan is a Principal Scientist in Purification Technologies & Enzymes at Novo Nordisk Pharmatech A/S. His specialties include identification and development of purification technologies, Strategic research management. Process development and technology transfer to manufacturing level. He is also an experienced project manager.

Dr. Jörg Thömmes is the Head of CMC (Chemistry and Manufacturing Controls) at Bill & Melinda Gates Medical Research Institute. His previous background includes studies at the University of Dusseldorf and the University of Bonn. Dr. Thömmes has subsequently held leading positions in technical development and operations at Biogen Idec and Visterra.

The SAB members’ range of experience and strengths will significantly add to the company’s external profile, improve our strategic and tactical decision-making, and thus strengthen our growth potential over time. Bio-Works is very satisfied with the recruitment of these individuals to our SAB.

Mats Johnson, Bio-Works CEO:
”We are extremely happy to be able to present these four eminent members of our newly formed SAB. They will in a very good way add to and support the future development of the company with their knowledge, experience and considerable networks. We continue to build the company, step-by-step, according to plan.”

For more information please visit Bio-Works’ homepage, www.bio-works.com, or contact Mats Johnson, CEO for Bio-Works, e-mail: mats.johnson@bio-works.com, telephone: +46 70 516 53 37.

About Bio-Works

Bio-Works designs, develops, manufactures and supplies innovative leading edge agarose products for chromatographic separation of proteins, peptides and other biomolecules. The company is staffed by people with long experience in the biotech industry and particularly with protein separation media.  Bio-Works’ agarose based high performance products are used for purificationin the life science  research phase as well as the commercial production of biopharmaceuticals and diagnostic products in large scale. The products are sold globally with our own organization and via distributors. Bio-Works facilities are located in the Uppsala Business Park Uppsala, Sweden. Company processes and a Quality Management System follows the standards of ISO 9001:2008. The Bio-Works’ share is traded on Nasdaq First North in Stockholm. FNCA Sweden AB is the Certified Adviser.

Bio-Works opens sales office in USA

Press release March 20th 2018

Bio-Works has opened a sales office in Philadelpia, USA to meet the large demand for separation and purification products for the production of biological medicine in the American market. To be able to support the customers at the right competence level the office will initially be manned with Swedish personnel. Bio-Works will during this year start to build a network of local sales people who will in the future manage the customer relations in USA and Canada.

Mats Johnson, Bio-Works CEO:
”While South Korea is the single most important market for biosimilars, not the least in Asia, USA is the single most important market for agarose based purification of biomolecules for production of original biopharmaceuticals. Many of the original biopharmaceuticals are developed in the US and the rest of the world often copies how the production is done there. Thus it is strategically important to have a good position in the American market. With the establishment of our American office, in combination with our on-going sales activites together with Amicogen in South Korea, we have a good coverage of prioritized markets.”

For more information please visit Bio-Works’ homepage, www.bio-works.com, or contact Mats Johnson, CEO for Bio-Works, e-mail: mats.johnson@bio-works.com, telephone: +46 70 516 53 37.

About Bio-Works

Bio-Works designs, develops, manufactures and supplies innovative leading edge agarose products for chromatographic separation of proteins, peptides and other biomolecules. The company is staffed by people with long experience in the biotech industry and particularly with protein separation media.  Bio-Works’ agarose based high performance products are used for purificationin the life science  research phase as well as the commercial production of biopharmaceuticals and diagnostic products in large scale. The products are sold globally with our own organization and via distributors. Bio-Works facilities are located in the Uppsala Business Park Uppsala, Sweden. Company processes and a Quality Management System follows the standards of ISO 9001:2008. The Bio-Works’ share is traded on Nasdaq First North in Stockholm. FNCA Sweden AB is the Certified Adviser.

Bio-Works secures another order from PolyPeptide

Press release Februari 23 2018

Bio-Works has received an order of 1,0 million SEK from PolyPeptide. During 2017 Bio-Works received four orders from PolyPeptide, which is one of the largest contract manufacturers in the world for peptide pharmaceuticals. They have 25 % of the global market for contract manufacturing of peptide pharmaceuticals. This order will be delivered during the first quarter of 2018.

Mats Johnson, Bio-Works CEO:
The high frequency of orders from PolyPeptide shows their trust in that Bio-Works’ products will give them the optimal productivity in scale-up and in their transition to industrial production. We are very happy for the trust PolyPeptide once again shows us in ordering our products. We look forward to a continued good collaboration.

Bio-Works’ historical sales figures represent the earlier phases of our customers’ scale-up processes, which is the development phase before industrial production. In industrial production each project a customer is running, can be worth up to 10 million SEK in yearly revenue for Bio-Works. At the 105 customers Bio-Works have today, approx. 10 projects are at the end of the scale-up phase, the last stage before industrial production. We expect for that several of our customers’ scale-up projects will move into production during this year.”

For more information please visit Bio-Works’ homepage, www.bio-works.com, or contact Mats Johnson, CEO for Bio-Works, e-mail: mats.johnson@bio-works.com, telephone: +46 70 516 53 37.

About Bio-Works

Bio-Works designs, develops, manufactures and supplies innovative leading edge agarose products for chromatographic separation of proteins, peptides and other biomolecules. The company is staffed by people with long experience in the biotech industry and particularly with protein separation media.  Bio-Works’ agarose based high performance products are used for purificationin the life science  research phase as well as the commercial production of biopharmaceuticals and diagnostic products in large scale. The products are sold globally with our own organization and via distributors. Bio-Works facilities are located in the Uppsala Business Park Uppsala, Sweden. Company processes and a Quality Management System follows the standards of ISO 9001:2008. The Bio-Works’ share is traded on Nasdaq First North in Stockholm. FNCA Sweden AB is the Certified Adviser.

Bio-Works säkrar ytterligare en order från PolyPeptide

Pressmeddelande den 23 februari 2018, kl: 07:37

Bio-Works har erhållit en order värd 1,0 miljon kronor från PolyPeptide. Under 2017 erhöll Bio-Works fyra ordrar från PolyPeptide, som är en av världens största kontraktstillverkare av peptidläkemedel och står för 25 % av den globala produktionen av peptidläkemedel hos kontraktstillverkare. Den senaste ordern kommer att levereras till kunden under det första kvartalet 2018.

Mats Johnson, VD på Bio-Works:

”Den höga frekvensen av ordrar från PolyPeptide visar på det förtroende de har för att BioWorks produkter ska ge dem optimal produktivitet i uppskalningsfasen och vid övergången till industriell produktionsfas. Vi är mycket glada för det förtroende PolyPeptide återigen visar oss genom att beställa våra produkter. Vi ser fram emot ett fortsatt gott samarbete.Bio-Works historiska försäljningssiffror representerar de tidiga faserna av våra kunders uppskalningsprocess vilket är utvecklingsstadiet innan industriell produktion. Vid industriell produktion kan varje enskilt projekt hos en kund vara värt upp till 10 miljoner kronor i årliga intäkter för Bio-Works. Hos de 105 kunder Bio-Works har idag befinner sig ca 10 projekt i slutet av uppskalningsfasen vilket är det sista utvecklingsstadiet innan industriell produktion. Vi räknar med att flera av våra kunders uppskalningsprojekt under året går in i produktion.”

För ytterligare information, vänligen besök Bio-Works webbplats, www.bio-works.com eller kontakta: Mats Johnson, VD för Bio-Works, e-post: mats.johnson@bio-works.com, telefon: +46 70 516 53 37.

Om Bio-Works

Bio-Works är ett bioteknikbolag som utvecklar, producerar och säljer innovativa separationsmedieprodukter baserade på agaros för att rena proteiner, peptider och andra biomolekyler. Bolagets produkter används huvudsakligen för att rena biologiska läkemedel och diagnostiska produkter, från forskningsfasen till produktion i stor skala. Produkterna säljs globalt dels genom den egna organisationen, dels via distributörer. Bio-Works anläggning är i Uppsala Business Park i Uppsala, Sverige. Bolagets aktie är noterad på Nasdaq First North. FNCA Sweden AB är utsedd Certified Adviser.

Interview with Dr. Yong Chul Shin, CEO of Amicogen Inc.

Amicogen Inc. is the largest shareholder in Bio-Works Technologies AB as of today, with slighty less than 10% of the shares. The planned listing on First North Stockholm is set to 14th of december.


1. What do you think makes Bio-Works unique?

“Bio-Works has developed a protein purification resin optimized for its customers through its long experience and technology development. Bio-Works has a unique patent on manufacturing agarose beads and Bio-works’ bead has the advantage of being harder than existing agarose resins, increasing binding capacity, reducing working time by increasing flow rate. Bio-Works also differentiates itself from competitors such as GE Healthcare, which dominates the existing global market by more than 70%. Bio-Works targets small and medium-sized organizations (universities, research institutes, etc.) or companies that our competitors do not offer enough technical support to. Biopharmaceuticals are expected to develop further in the future, and as these early-stage companies and medium-sized enterprises grow into large corporations, Bio-Works’ business will grow alongside them. Bio-Works distinguishes itself from existing companies in terms of products (technology) and customer target.”

2. Please explain the synergies of the collaboration between Amicogen and Bio-Works.

“Amicogen is a protein engineering company specializing in industrial enzymes and protein A for antibody purification. In recent years, Amicogen has developed a ligand that retains its activity at the time of cleaning in place (CIP) by imparting alkali resistance to Protein A. In order to make a “protein purification resin” using an affinity ligand developed by Amicogen, stable agarose resin is required. Amicogen started working with Bio-works, which has a competitive agarose resin manufacturing technology. Amicogen and Bio-Works will continue to jointly develop various affinity resins for antibody purification and combine our strengths to create synergies that will enable us to produce the best products. In addition, the city of Uppsala, Sweden, where Bio-Works is located, is the world’s best city in the field of protein purification resins. On the other hand, Korea, where Amicogen is located, will have the largest production capacity of biosimilars in the world by 2018, as well as a number of start-ups and small- and medium-sized companies in the biopharmaceutical sector. Amicogen is planning to sell Bio-Works’s protein purification resins to Korea, China and Southeast Asian markets and has already started doing so in Korea. Considering the above, we believe that both companies will have great synergies not only in terms of technology but also in business.”

3. Where do you see the Amicogen and Bio-Works collaboration in three years?

“Amicogen will work with Bio-Works to develop alkali-resistant Protein A resins and introduce Bio-Works protein purification resins to the Korean market, and provide sales and technical support services. As already discussed, Korea has the largest biosimilars production facility in the world, and there are many initial companies and small and medium sized enterprises. This environment is expected to lead to opportunities for protein purification resin business in Korea. Amicogen plans to launch Bio-Works products in the Chinese market through its Chinese subsidiary (Amicogen China Biopharm, LLC). Next, Amicogen will expand its business to Southeast Asian markets, including India. In recent years, India and China have been expanding their biopharmaceutical market based on a strong growing domestic market, and their marketability is very high. In the future, the production capacity of Bio-Works will be insufficient. Amicogen hopes to cooperate with Bio-Works to build a second Bio-Works factory in Korea and to promote its business to supply products to China and Asia.”

4. Who are the costumers that are underserved today in the market and how do you plan on serving them?

“In Korea, GE Healthcare (GEHC), which occupies 70% of the global market for agarose resins, is almost monopolized. Since GEHC mainly cares about large companies as customers, early companies and small and medium-sized enterprises are not receiving enough services for protein purification resin and resin technology. Amicogen and Bio-Works are working to target these potential companies. On the other hand, large companies are also looking for a new reliable protein purification resin supplier that can compete with GEHC. This is because there is no price bargaining power due to GEHC’s exclusive market position, and if GEHC’s product supply is unstable, there will be a serious problem that stops research or production of its own new drugs. As a Korean company, Amicogen is able to maintain a close relationship with Korean companies and will quickly meet the needs of customers by providing products and technical support that they want.”
 
5. Explain the importance of protein A in development and production of biosimilars.

“Protein A is a resin that is essential for the production of antibody biosimilars and is critical in the purification process. The reason is that Protein A has a specific affinity for the antibody, so that high purity antibody can be obtained in an animal cell culture with a single step alone. On the market, Protein A is considerably more expensive than other resins, so good-quality resins are preferred, and more than 100 times of reusable alkali-resistant Protein A resins are required. In detail, Protein A resin is cleaned by alkaline washing (CIP) using Sodium hydroxide (NaOH) after the antibody is purified. It can be used for next antibody purification. Therefore, customers need alkali-stable Protein A resin in order to maximize the use of resin. Bio-Works and Amicogen will release alkali-resistant Protein A resins to meet the needs of the industry. Considering that most of the recently developed biosimilars are antibody-based biopharmaceuticals, the market for Protein A resins is expected to grow rapidly as the market for biosimilars grows.”

6. How can producers of biosimilars benefit by using Amicogen and Bio-Works products instead of competitor’s products?

“The development of biotechnology has shifted the pharmaceutical market from synthetic drugs to biopharmaceuticals. For example, the share of biopharmaceuticals in total pharmaceuticals is expected to increase gradually from 19.9% ​​in 2016 to 23.4% in 2021. In particular, among biopharmaceuticals, the biosimilar market, which is a replication drug, is rapidly expanding due to budget cuts in the medical sector and patent expiration of blockbuster biopharmaceuticals. On the other hand, as the market is getting bigger, competition among companies is expected to become more intense. In the end, price competitiveness will be the most important factor in survival. In order to be competitive in price, production cost should be reduced as much as possible.

Firstly, Amicogen and Bio-Works’s products have higher caustic ratios than their competitors. The compact, high-density resin has a higher resolution than other products and has high durability to maintain performance at high flow rates. In addition, by offering competitive resin prices, customers can use our products to secure price competitiveness of their products. Secondly, it is customized technical support service. Customers require optimized production processes to go through technical support services. Protein-based biosimilars have a much more complex molecular structure than the chemically based generics. That is, in order to increase the production efficiency, a resin and a purification process should be established taking into account the characteristics of the product (protein drug). We, Amicogen and Bio-Works, will cooperate in establishing the optimal purification process by participating from the customer’s biosimilar development stage.”

7. Can you provide some insight into the biologics and biosimilars market in South-Korea and how it is developing?

“For the success of the biosimilars market, it is crucial to having price competitiveness through large-scale facility investments and to leading the global market after the expiration of patents for biosimilars. Although Korea did not have a production facility before 2009, it is emerging as a major producer with aggressive investment by Korean companies. For example, Celltrion plans to build a new plant to hold a production capacity of 310,000 liters per year by 2019, and Samsung Bio Logics plans to increase production capacity by 2018 to 360,000 liters per year, which means the world’s largest capacity of CMO manufacturing. In addition, Korea’s biomedical market, which has been growing mainly in large corporations so far, has been showing a lot of technological start-up companies through strong government policies. In particular, large companies such as Hanmi Pharm are establishing mutually cooperative partnerships through open innovation, such as investing in initial companies and conducting clinical trials with technology transfer. The Korean government is continuously expanding R & D investment, fund management, and clinical infrastructure building to promote the bio-industry. For example, the government has invested KRW 234.4 billion in innovative drug development research in 2016, and operates a global pharmaceutical fund to strengthen domestic drug development capabilities. As a result, the number of new drug products increased to 28 in August 2017, and licensing-out also increased, resulting in revenue of more than KRW 3 trillion through 11 technology export contracts in 2016. Through such win-win partnerships and strong government support, Korea’s biomedical market is expected to grow significantly in the future.”

8. Why and in what way are companies like Samsung, Celltrion and others investing in this market and how is your relationship with them?

“The start-up and growth of biotechnology companies are also important for the government, universities, and citizens to support the bio-industry as future food. Korea has a well-established system for mass production of precision and high-tech products such as semiconductors, mobile phones, LCDs, and chemical products. Although Korea is a very small country, it is the 8th largest (2016) exporting country and has national competitiveness. In addition to large corporations based on this environment, many bio companies have been established in Korea and are challenging the future biopharmaceutical market. Research initially focused on the development and commercialization of biosimilars (generic products for biopharmaceuticals), but at the same time focusing on the development of new biopharmaceuticals.
Amicogen is a company founded by scientists from universities and research institutes, and maintains a close network of biotech researchers in Korea. In addition, we can better understand the Korean market than foreign companies (such as GEHC), and can quickly provide products and technologies to meet customers’ needs. Korea is a rapidly growing market for biopharmaceuticals, and there are many opportunities for Bio-Works to enter the market. Amicogen expects the collaboration business with Bio-Works to grow significantly in the future.”

 

Read the interview through the original source