BUSINESS INSIGHTS

CEM Corporation and AmbioPharm enter into US partnership for GMP peptide production

CEM Corporation | September 16, 2021

CEM Corporation and AmbioPharm, Inc. are pleased to announce the formation of a partnership to produce GMP peptides for the global market. The partnership includes the exclusive 1Use of CEM's microwave peptide synthesis technology on a large scale for the production of GMP peptides up to several kilograms using its own scalable reactors. The main advantages of this new relationship are the extremely short production times, the ability to efficiently produce more difficult peptide sequences, and the ability to incorporate green chemistry protocols. This partnership will enable the rapid and efficient production of new chemical peptide entities (NCEs) using the latest available technologies. With this agreement, AmbioPharm has started peptide synthesis at its North Augusta facility to better serve customers with fast microwave synthesis processes.

CEM's peptide production technology utilizes automated, large-scale microwave solid phase peptide synthesis systems (SPPS) that have been proven to improve peptide purity and minimize excess reagents. In addition, the CEM has developed proprietary coupling methods optimized for reactions at elevated temperatures 2 , a unique way to combine the coupling and deprotection reactions in a single step 3 , and established the use of more environmentally friendly solvents that are more accessible at elevated temperatures 4 . These unique technological advantages are licensed to AmbioPharm for GMP production.

AmbioPharm is a recognized leader in cGMP peptide production. The company employs more than 675 people and recently completed a major expansion of its headquarters in South Carolina, USA, adding nearly 56,000 square feet of additional peptide manufacturing capacity. The production plant has a cleaning capacity of up to 30 kg / batch and a freeze-drying capacity of up to 1,000 liters. The CEM Liberty Pro Synthesizer offers different reactor sizes (3, 8 and 15 liters) that allow the synthesis of batches from 5 g to 500 g of the final peptide.

Peptide-based drugs have enormous potential for the future and we are pleased to be able to help improve their production process. AmbioPharm is an ideal partner and we believe this relationship will enhance the opportunities for the manufacturing of peptide therapeutics.

- Michael J. Collins, Ph.D., President and CEO of CEM Corporation.

With the addition of CEM's microwave technology to our GMP peptide manufacturing options, we can offer even better service in terms of faster delivery for our partners' products and unique opportunities to make longer and more complex peptides accessible using microwave methods.

- Chris Bai, Ph.D., CEO of AmbioPharm Inc.

About CEM
CEM Corporation, a privately held company based in Matthews, North Carolina, is a leading provider of laboratory instruments. The company has subsidiaries in the UK, Germany, Italy, France, Japan and Singapore and a worldwide network of distributors. CEM designs and manufactures systems for life sciences, analytical laboratories and processing plants worldwide. The company's products are used in many industries, including the pharmaceutical, biotech, chemical and food industries, as well as academic research.

About AmbioPharm, Inc .
AmbioPharm, part of the Ambio Pharmaceuticals Group, is a leading, innovation-driven company that specializes in the development and manufacture of peptides and peptide-like products. AmbioPharm offers a comprehensive range of services and produces customized products for research, clinical development and commercial use for pharmaceutical and biotechnology companies worldwide. AmbioPharm operates internationally, has its headquarters in the USA, locations in Europe, the USA and Asia and has more than 14 years of experience and expertise.

Spotlight

Connectivity in general is becoming an ever more important consideration for production facilities as we endeavour to produce more with less and all the while trying to satisfy an increasing need for more information and communication to and from the production equipment itself.

Spotlight

Connectivity in general is becoming an ever more important consideration for production facilities as we endeavour to produce more with less and all the while trying to satisfy an increasing need for more information and communication to and from the production equipment itself.

Related News

BUSINESS INSIGHTS, PHARMA TECH

Hovione and Ripple Enter Strategic Partnership to Expand Epidel® Platform into Non-Ophthalmic Space

Hovione | March 21, 2023

Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, and Ripple Therapeutics, a leading ophthalmic sustained drug delivery company, have entered a strategic partnership to expand the use of Ripple's Epidel® platform beyond ophthalmic applications. The core feature of Ripple's Epidel® technology is the ability to deliver sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. This enables higher drug loading, smaller size implants, defined and predictable biocompatible degradation products with straightforward and scalable manufacturing processes. Surface erosion-based drug release provides a highly effective way to control dose and duration. By incorporating Ripple's Epidel® platform into its toolbox, Hovione can expand its portfolio of novel drug delivery solutions to the pharmaceutical industry. "The combination of technology synergy, innovative vision and cultural fit makes collaborating with Hovione an exciting next step in the advancement of the Epidel® platform beyond the ophthalmic field," stated Dr. Wendy Naimark, Ripple co-founder and Chief Technology Officer. "Hovione's expertise in controlled, sustained drug delivery, along with their experience in chemical synthesis and pharmaceutical manufacturing, makes for a great partnership." "We are thrilled to partner with Ripple, who developed a state-of-the-art platform for sustained release," says Dr. Jean-Luc Herbeaux, Hovione's CEO. " Our shared goal is to accelerate and broaden the access to this highly innovative and enabling technology for the benefit of our pharmaceutical customers and their patients worldwide." By extending the use of the Epidel® platform beyond ocular applications, this partnership will enable the development of a diverse range of new products with optimal sustained release profiles. About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione's culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About Ripple Therapeutics Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple's Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. Ripple's novel therapeutics provide for better outcomes for patients, easier management of care for physicians and lower costs for payors. Ripple has a full product pipeline in development.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Endo Launches Authorized Generic Version of Noxafil® (posaconazole) Oral Suspension

Prnewswire | April 04, 2023

Endo International plc announced that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping the authorized generic (AG) version of Merck's Noxafil® (posaconazole) 200 mg/5 mL oral suspension in the U.S. "Our partnership with Merck underscores our reputation as an industry-leading supplier," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "This newly available Noxafil® AG dosage form is the latest addition to our generics portfolio—providing patient access to high-quality, lower-cost treatment options." Endo subsidiary Endo Ventures Limited entered into an exclusive U.S. supply and distribution agreement with a subsidiary of Merck & Co., Inc. of Rahway, N.J. allowing Par to launch and distribute an authorized generic version of the product. The agreement also included the authorized generic version of Noxafil® delayed-release tablets, 100 mg, which launched in 2019. Noxafil® is a registered trademark of Merck Sharp & Dohme LLC. About Endo International plc Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them.

Read More

PHARMA TECH

Sony and Astellas Enter into Collaborative Research Agreement to Discover a Novel ADC Platform for the Oncology Field

PRNewswire | May 17, 2023

Sony Corporation and Astellas Pharma Inc. announced that they have entered into a collaborative research agreement to discover a novel Antibody-Drug Conjugate (ADC) platform in oncology based on Sony's unique polymeric material, "KIRAVIA™*2 Backbone." ADC is expected to selectively deliver anti-cancer drugs to target cells, thereby increasing efficacy and reducing side effects caused by anti-cancer drugs attacking normal cells. The technology to create linkers which conjugates antibodies and drugs, is considered to be a key to development of a better-performing ADC. This collaborative research leverages the flexibility in design and resulting properties such as high capacity and solubility of KIRAVIA Backbone as a linker of ADC, to effectively deliver anti-cancer drugs to targeted cells in a stable manner, aiming to further enhance therapeutic efficacy by achieving high Drug-to-Antibody Ratio (DAR) etc. The two companies jointly began exploratory research of new linker technology aimed at creating a new ADC platform in July 2022, and the expected profile was obtained in feasibility studies using human cancer cells. Under this agreement, Sony and Astellas will jointly develop and optimize a new ADC platform using the KIRAVIA Backbone as a linker. In addition, Astellas will conduct non-clinical trials of development candidates. Furthermore, in order to build a drug discovery platform not limited to ADC, the two companies have agreed to continue discussions on expanding research partnerships to create new value by combining Sony's cutting-edge technology with Astellas' renowned pharmaceutical capabilities. "Sony's life science business has accumulated substantial knowledge in the field of cell analysis," said Katsunori Ogawa, Head of Life Science & Technology Business Unit at Sony Corporation. "Through this collaboration, Sony is striving to contribute to the medical and drug discovery fields and provide further social value by leveraging Sony's technological capabilities in the development of anti-cancer drugs therapy, which are expected to grow." "We are pleased to enter into a joint research agreement with Sony," said Yoshitsugu Shitaka, Ph.D., Chief Scientific Officer (CScO), Astellas Pharma Inc. "Astellas is working to create innovative drugs from a multifaceted perspective called the Focus Area approach*4, which identifies combinations of biology, therapeutic modality or technology and diseases with high unmet medical needs. The partnership will further strengthen our ability to utilize suitable modalities. It is our expectation that the collaboration will lead to the continuous creation of innovative drugs for patients around the world." ADC is a modality that combines an antibody and a small molecule such as an anti-cancer drug via a linker. It is expected to selectively deliver anti-cancer drugs to target cells, thereby reducing side effects caused by anti-cancer drugs attacking normal cells. KIRAVIA™ and KIRAVIA Dyes™ are registered trademarks or trademarks of Sony Group Inc. or its affiliates. KIRAVIA Backbone is created using the organic polymer technology cultivated in KIRAVIA Dyes™, which Sony independently developed and licensed to reagent manufacturers. It features a high degree of freedom in design, as the three-dimensional structure is programmed and polymerized using an automatic synthesizer. While increasing the number of drugs to be added and cleaving by reacting with intracellular enzymes. Synthesis of linkers with functional properties and selective drug release is expected. About Astellas Astellas Pharma Inc.is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients.

Read More