May Supplement Spotlight

World Vaccine Congress Names “Best CMO”

At its annual meeting in Washington, DC, this past March, the World Vaccine Congress named Paragon Bioservices, Inc., as the “Best Contract Manufacturing Organization” (CMO) for 2016. The annual Vaccine Industry Excellence (ViE) Awards honor the industry’s most outstanding achievements in vaccine development around the world. This award is based on the service range in niche and core therapeutic areas, methods of performance improvement, attention to and quality of relationships with clients, reaching milestones and outcomes, and building and maintaining long-term partnerships.

Paragon’s focus is development and manufacturing of biopharmaceuticals — including production and purification of recombinant proteins, viral vectors, and vaccines. The company provides research services, process development, and current good manufacturing practice (CGMP) manufacturing. The company’s CGMP facility includes microbial and mammalian cell culture and downstream processing suites, aseptic fill and finish areas, and a fully segregated virus-safety operation. It functions as a translational bridge from research laboratory-scale through manufacturing of finished drug products for phase 1–2 clinical trials. Paragon seeks to build strong partnerships with its biopharmaceutical clients, focusing on oncology immunotherapies (chimeric antigen receptor T-cell therapies and oncolytic viruses), next-generation vaccines (virus-like particles), and gene therapies (adenoassociated viruses).

“Credit for this recognition goes, first and foremost, to our hard-working scientists, engineers, quality systems personnel, and project managers,” said company president Peter Buzy. “This acknowledgment from our peers is a great honor, and we hope it reflects our dedication and passion for the science.”

Now in its 16th year, the World Vaccine Congress covers the latest research and development and manufacturing technologies as well as corporate development strategies. It also hosts the only awards ceremony dedicated to the vaccine industry. The ViE Awards honor individuals, organizations, and initiatives that have made significant contributions over the past 12 months to innovation in the field of vaccines.

Vetter Wins Two Awards

In February, the World Packaging Organization (WPO) awarded Vetter the 2016 WorldStar Award for its Vetter-Ject syringe-closure system. This is the fourth award for the product released in July 2015, after the IF Design Award, the Red Dot Design Award, and the 2015 German Packaging Award. The WorldStar competition is open to packaging solutions that have already won awards. Representatives from 19 packaging associations judged 293 projects from 35 countries. Vetter also won the 1998 WorldStar award for its Lyo-Ject dual chamber syringe.

Claus Feussner (Vetter Development Service’s senior vice president) said these awards “are a validation of the novel design and technological advances” of the Vetter-Ject system. It consists of a needle hub and shield, with a baked-in siliconization process for the glass barrel that allows for use of less silicone oil than is normally needed. So the product is suitable for silicone-sensitive drugs, coming ready-to-use with an integrated needle. A tamper-evident closure makes previous attempts to open the closure system immediately and permanently visible to the naked eye.

Winner of Four 2016 CMO Leadership Awards: Efficient vetting of potential CMO partners is a difficult experience for biopharmaceutical executives. In an effort to assist, Life Science Leader magazine created the CMO Leadership Awards. For 2016, more than 80 companies were assessed according to 26 performance metrics in Industry Standard Research’s (ISR) annual contract manufacturing quality benchmarking survey. Together, LSL and ISR named Vetter the winner of four categories: quality, capabilities, expertise, and compatibility.

“Vetter is pleased to be a recipient of this award, particularly since it is a direct reflection of our customers’ experience in having worked right alongside us,” said managing director Peter Soelkner. In this award program, only votes from companies that have used CMO services on a project within the past 18 months are counted.

TxCell Launches New Facilities

In February, TxCell SA announced new process-industrialization laboratories and technology-transfer academy facilities for cell-therapy projects in Sophia Antipolis, France. Primarily dedicated to improving the company’s existing platform manufacturing process and development of a new one, these facilities are intended to increase automation and economic efficiencies and shorten the manufacturing process for all TxCell products.

Chief operating officer Miguel Forte said, “The only clinical-stage cellular therapy company dedicated to the science of regulatory T lymphocytes (Tregs), TxCell is integrating its own research with recent technological advancements across a variety of fields to make the manufacturing process of our product portfolio as economic as possible.”

The TxCell Academy for Technology Transfer will be responsible for educating and training all of TxCell’s contract manufacturing partners, including MaSTherCell. In addition, the academy will train future strategic partners (licensed and/or codeveloping pharmaceutical companies) on personalized cell therapy manufacturing processes. The new facilities will be based on the premises of GenBiotech, a spin-off of the Laboratoires Genevrier. That company works in the fields of rheumatology, dermatology, and gynecology.

Aesica Moves on API Manufacturing Trends

Contract development and manufacturing organization (CDMO) Aesica Pharmaceuticals sees high levels of regulation coupled with continued evolution of the global market creating challenges in the active pharmaceutical ingredient (API) manufacturing industry as an opportunity.

“Competition with low-cost suppliers is challenging,” says managing director Ian Muir, “yet represents an opportunity for Western suppliers to continue to drive operational efficiency through continuous improvement activities within a controlled and regulated environment to be competitive. Overall consolidation of contract partners expands capabilities and allows for greater control of the supply chain.”

Some API manufacturers have observed a trend in companies preferring locations in the West because of recent quality issues and rising production costs in some traditionally low-cost markets. This trend intensifies at later stages of product development, and it’s different for generics/biosimilars, where Muir says competition between the East and West seems to be healthier. “When introducing new products to the market, companies tend to favor Western suppliers in order to mitigate risk.”

British healthcare organization Consort Medical acquired Aesica in November 2014. The former develops and manufactures medical devices for inhaled, nasal, and injectable drug delivery products through an operating division called Bespak. Aesica’s CMO management service handles third-party contractors on behalf of clients to provide a single point of contact. The combined group now provides finished-dose manufacturing, formulation development, pilot to high-volume API manufacturing, and prototype development and design for devices. Aesica intends to increase its high-potency API capabilities in the future.

The company has recently added development capability with the opening of a new purpose-built facility in Queenborough, UK. This doubles its development capacity for manufacturing multiple drug products up to phase 3 clinical trials. Aesica now can develop and manufacture a client’s product from early formulation development through clinical manufacturing into commercialization — covering all aspects of a product life cycle at one site. The facility handles highly potent drugs up to SafeBridge Category 3, together with controlled drugs, and is licensed for Schedules 2–4. It is experienced in handling drugs that are both highly potent and controlled.

“In response to growing customer demand,” Muir explains, “and as part of our ongoing strategy to simplify the supply chain, we have taken the strategic initiative to ensure that our high-capacity Queenborough Development Centre provides a complete service offering for multiple customers.” He called high-potency drugs “a key contract services market with strong growth potential, requiring a mix of highly specialized and advanced technological skills and capabilities. We have set these resources in place and taken the strategic initiative to combine them with full clinical and commercial-scale manufacturing capacity in this highly complex field from a single site location.”

Alliance: Abzena and FairJourney Biologics

This past spring, UK-based Abzena plc and Portugal-based FairJourney Biologics (FJB) announced a marketing alliance. Abzena says it will provide antibody discovery services to its contract partners and allow FJB to offer immunogenicity assessment and analytical services to its own clients. Abzena will also include cell-line development, process development, and manufacturing services to FJB’s customers. The combined offering from both companies provides a continuum of services from antibody discovery to GMP manufacturing of materials for phase 1 and 2 clinical trials.

FJB has developed multiple naïve and immune Fab phage-display libraries and can provide rodent, llama, or human antibodies in different formats against customer targets. Bespoke libraries also can be constructed and used exclusively for particular clients. The company performs binding and functional assays on antibody candidates. Through Abzena, it will add an enhanced range of assays for assessing immunogenic potential to aid selection of lead product candidates.

Both companies offer protein-engineering services to provide customers and partners with tailored, humanized antibodies. Abzena uses proprietary technology to give them a very low risk of triggering an unwanted immunogenic response in patients. Currently 11 such products are going through clinical development for Abzena partners. The company can develop manufacturing cell lines for antibodies discovered by FJB and provide process development and GMP manufacturing services at its own facility in San Diego, CA. Antibody–drug conjugate (ADC) products based on a range of highly potent drugs can be linked by proprietary conjugation technology and other established methods. Abzena makes and tests ADCs at facilities in Cambridge, UK and Bristol, PA.

Sally Waterman (senior vice president of corporate development at Abzena) says, “This alliance provides our partners with access to strong antibody-discovery expertise with our existing immunogenicity testing, protein engineering, and manufacturing capabilities. It means that we can support development of better therapeutic products by our partners from discovery to manufacture for clinical trials.”

FJB’s chief scientific officer Maria Pajuelo added, “Through Abzena, we are now able to offer a wider range of services and give our customers the option to take discovery projects to the next stage. We believe that this will bring real benefits and facilitate the efficient delivery of novel products to patients.”

Recipharm Buys Majority of Nitin Lifesciences

In April, Recipharm AB announced that it had completed acquisition of a majority stake (74%) in Nitin Lifesciences Ltd., an Indian CMO that makes sterile injectables, from its private owners, the Sobti family. “The combination of Nitin and Recipharm represents an important step in development of both companies,” said Thomas Eldered, chief executive officer of Recipharm. “I am pleased that both Chetan and Nitin Sobti will be continuing in their current positions.”

Nitin founder MM Sobti said, “This partnership represents a real opportunity to take Nitin Lifesciences to a new level. The combination allows both organizations to access a wider customer base and to gain important learning from each other.”

The combined entity will have enhanced scale, reach and profitability. Headquartered at Karnal in northern India, Nitin Lifesciences had 2015 net sales of about 2.97 million rupees, corresponding to about 12% of Recipharm’s total net sales for the same year. Nitin’s EBITDA margin for 2015 was about 24%. It has three facilities for manufacturing small-volume parenteral drugs, the newest of which began operation in 2014. Essentially debt-free, the company will continue to trade as Nitin Lifesciences Ltd.

The merger significantly bolsters Recipharm’s presence in high-growth developing territories, and the deal firmly establishes its emerging market strategy. The company looks forward to this exposure and direct entry into the rapidly expanding Indian market. Its global position in sterile injectables (including lyophilization) also will be strengthened.

According to the India Brand Equity Foundation, the overall drug contract manufacturing industry in India is currently growing at a rate of 20%. The current market value is estimated at 50% of domestic production, which roughly translates to US$5.3 billion. Multinational corporations hold a 20–25% stake in the Indian pharmaceutical market.

Boehringer Ingelheim Pilots in China

In February, German CMO Boehringer Ingelheim announced that its Chinese subsidiary was chosen to launch the country’s first biopharmaceutical CMO pilot project. The facility is jointly developed by BI and Shanghai Zhangjiang Biotech & Pharmaceutical Base Development Company. Their first client will be BeiGene for oncological immunotherapies.

“The launch of the CMO pilot project marks a key milestone for our biopharma business in China,” said Luo Jiali, general manager of Boehringer Ingelheim Biopharmaceuticals (China) Co. Ltd. “We will accelerate development of the biopharma site, break the original manufacturing bottleneck in the biopharma industry chain, and provide our clients with the world’s leading contracted manufacturing management and quality assurance system as well as supply chain management for the products. We will also team up with more medicine-research enterprises and institutions to promote clinical research and market debut of innovative products. We will leverage our advanced manufacturing platform and management expertise to help Chinese enterprises bring their products to global markets. We are very glad that we are playing an important and active role in fostering China’s biopharma CMO pilot project.”

BI has advanced technology and abundant experience in the biopharmaceutical field. It will help Shanghai’s regulatory authorities better monitor the quality of biomanufacturing, facilitate commercialization of the sector in Shanghai and China overall, and contribute to the city’s efforts to develop a technology innovation center with global influence.

In August 2015, the Chinese State Food and Drug Administration submitted a request to the State Council to launch a pilot marketing authorization holder program in 10 provinces and municipalities. By the end of 2015, the Standing Committee of the National People’s Congress had authorized the State Council to carry out this pilot program, providing a legal basis for biopharmaceutical CMOs and an example to demonstrate how the marketing authorization holder system will work. Drug-approval number holders can be production enterprises, research institutes, or researchers who are thus required to market drugs on their own and take responsibility for them throughout their product life cycles. After receiving approval numbers, holders can either manufacture drugs on their own or choose contract manufacturers instead. Contract manufacturing will help to separate drug-marketing authorization holders from drug-production enterprises and is expected to help grow the Chinese industry. Before this program, drug-research companies had to develop their own production lines and could not engage with contract manufacturers.

The biopharmaceutical industry is one of several industries highlighted in China’s 12th five-year plan. It has been difficult for drug-research companies to put new drugs into commercial use there because of technological challenges. Launch of the CMO pilot project will help break that bottleneck of manufacturing. Research enterprises can now focus on developing innovative drugs while biomanufacturers focus on commercial production and quality control.

David Preston, president and chief executive officer of BI China, Hong Kong, and Taiwan, attributed launch of the biopharma CMO pilot project to “strong support of all levels of government units in Shanghai. Biopharma is one of our core businesses in China. We believe that the innovative CMO model will help more biopharma enterprises manufacture and market innovative biopharma products and provide Chinese patients with more high-quality innovative biomedicines.”