As we reach the end of CPhI Worldwide, we have some more revelations and innovations that keep coming from the vast show floor here in Frankfurt Messe, enjoy and until next year tschüß!
Frankfurt old town
Catalent completes acquisition of Cook Pharmica
Catalent, provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, completes acquisition of biologics contract development and manufacturing organisation (CDMO) Cook Pharmica.
This acquisition strengthens Catalent’s position in biologics development and analytical services, manufacturing and finished product supply. The complementary capabilities of Cook Pharmica will enable customers to accelerate biologic drug development programmes and bring better treatments to patients worldwide.
A reorganisation of Catalent’s operations is planned to create two dedicated business units. The first will recognise the company’s increased biopharmaceutical and fill-finish capabilities and the importance of the growing area of biologics to be led by Barry Littlejohns. The second is the reorganisation of the remainder of its former Drug Delivery Solutions business into a newly formed Oral Drug Delivery business unit to be led by Jonathan Arnold.
“The establishment of these focused business units reflects the rapid growth we are seeing across key markets, particularly for biologics and differentiated dosage forms,” comments John Chiminski, Chair and CEO of Catalent. “We have an exciting strategic plan to accelerate our portfolio of capabilities, as evidenced by the recent growth investments we have made, including multi-million-dollar site expansions and the newly completed acquisition of Cook Pharmica. We are confident that the experience and expertise of Barry, Jonathan, and Tedd will provide valuable leadership as we move forward in this exciting phase of our development.”
Hall: 4.1
Booth: 41G10
Website: www.catalent.com.
Transition metal catalysis centre
STA Pharmaceutical reveals plans to launch a new transition metal catalysis centre at the integrated API process R&D and manufacturing site in Changzhou, China.
This new facility will allow the company to perform rapid screening of metal catalysts, ligands, bases, acids, chemical resolving reagents and amide formation coupling reagents. The screening kits will enable high-throughput screening of metal catalysts and ligands for C-C, C-N, C-O and C-S formation reactions, as well as many other types of reactions such as chemical resolution and amide formation. Additionally, through this technology the STA Pharmaceutical team will be able to find the optimal catalysts more rapidly by using a parallel interactive testing approach.
Currently, a team of scientists who are specialised in the technology are being trained at the company’s R&D centre in Shanghai and will move to the Changzhou site once it is open and fully operational, which is anticipated to be in early November.
Hall: 6.1
Booth: 61C42
Website: www.stapharma.com
Expansion in lab capabilities
Sterling
Sterling Pharma Solutions, a contract development and manufacturing organisation (CDMO), is investing £6 million in new milling, micronisation and solid form facility at its UK site.
The new site in Dudley will see an expansion of the company’s laboratory capabilities to provide a full solid form offering including polymorph screening, salt selection and particle engineering and crystallisation scale-up.
Four new milling areas will house a range of new technologies, including mechanical milling, spiral jet milling and small lab scale trial mills. Additionally, the facility will provide containment to handle OEB 4 classified molecules and offer ISO 8 cleanroom environments.
“From our UK facility, we are building a global active pharmaceutical ingredient (API) services business with customers in the US, UK, Europe and Asia. This latest investment is an important step in bolstering our offering so we can cater for growing market demand, including the need for high potency capabilities to reflect the global drug pipeline,” says Kevin Cook, CEO at Sterling Pharma Solutions. “We are proud that we can take products from proof-of- concept to commercial scale manufacturing all on one site, and the new facility will strengthen our current offering by adding additional milling, micronisation and solid form capabilities.”
This investment is part of a 15-month strategic development plan, which will also see the expansion of the CDMO’s GMP kilo laboratories and pilot plant. The milling, micronisation and solid form facility is expected to be operational by mid-2018.
“Our strong growth can be attributed to a number of factors, including the emerging pharma sector in the US and big pharma demand for the complex and hazardous chemistries we provide,” continues Cook. “We have focussed our strategy on the diversification of our customer and product base and have recently expanded our presence in the Asian markets including Japan. We will continue to invest to ensure we meet the diverse needs of our customers globally.”
Hall: 8.0
Booth: 80M80
Website: www.sterlingpharmasolutions.com
Russian certification
European contract development and manufacturing organisation (CDMO), Saneca Pharma, receives confirmation of multiple dosage form approval for the manufacture and supply of solids, semi-solids and liquid finish dose products to Russia.
This cGMP certification was awarded to the company following an inspection by the Federal State Institution ‘State Institute of Drugs and Good Practices’ of Russia.
“We are delighted to have successfully completed this recent inspection. Russia is a key market for Saneca Pharma, forming an important part of our growth strategy. The certification demonstrates our commitment to meeting the needs of our growing client base in the country, while supporting customers in achieving compliance with various global regulatory authorities,” comments Anthony Sheehan, CEO at Saneca Pharma. “Russia’s importance to the pharmaceutical producers in Central and Eastern Europe is being increasingly recognised, with significant year-on-year revenue growth. Successfully passing this inspection is a challenging process for companies and it is a testament to both the expertise of our team, our quality systems and the condition of our manufacturing facilities that we have been successful in meeting the standards required.”
Hall: 4.1
Booth: 41K41
Website: www.saneca.com
Sharp reaches half century milestone
Sharp Packaging — a global provider of pharmaceutical packaging and clinical services — announces it has reached 50th serialisation line milestone in its track and trace programme.
“Many industry players have underestimated the impact that implementing serialisation can have on an organisation and have delayed their preparations for the Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (EU FMD), meaning they are underprepared and unlikely to be fully compliant in time for the deadlines,” emphasizes Rick Seibert, senior vice president of Global Innovation & Technology Service at Sharp.
“Serialisation is not a new concept. Sharp has been serialising products for almost a decade meaning we have a team of industry leaders with considerable expertise and depth of knowledge in this area.
“As a result, we can offer our customers a scalable and accelerated onboarding process, making their journey to compliance more streamlined and less time and cost intensive. We expect to see many companies, particularly small and mid-sized players, relying on outsourced packaging solutions in order to maintain continuity of supply post-enforcement dates.”
Hall: 4.1
Booth: 41B32
Website: www.sharpservices.com
Symbiosis opens US office
Responding to demand from US-based biotechnology companies for its vial-filling expertise, Symbiosis Pharmaceutical Services is announcing the opening of an office in the US.
This new site in Cambridge, Boston, Massachusetts, will support clients on both the East and West coast and will give the company a base to reach new customers in the territory.
“Given Cambridge is the epicentre of the global biotech community, it was the ideal location for us to open an office in the US. So far it has been a great success and we foresee that continuing as we continue to reflect the demand from US-based biotechnology firms looking for small-scale aseptic manufacturing resource,” explains Colin MacKay, CEO at Symbiosis Pharmaceutical Services. “Back in 2015, we took the decision to strategically focus on the North American market after we identified a surge in funding for early stage biotech companies, which are exactly the type of drug development company that are best suited to seek our manufacturing scale and specialist capabilities.
“As expected, our expertise in filling biologic and small molecule products, combined with our ability to offer rapid access to sterile manufacturing slots, has been very well received by pre-clinical and phase I-II biotech and pharma companies, which has helped to fuel our steady growth.
“Since strengthening our US-focused personnel and developing our relationships with networks like ISPE and MassBio, we have significantly grown our US client base which is projected to account for around half of our revenues in 2017. Opening the office on the US East Coast has added to the success of the company’s growth strategy.
“At a macro level, demand for biologic and highly potent products is likely being driven by the increased emphasis on the development of treatments for small patient populations in the case of orphan indications, new oncology products requiring containment capabilities and novel tailored personalised medicines.
“Those kind of products require specific GMP manufacturing skills for the small-scale production of sterile batches for clinical trials, hence the clear uptake in demand for what we do at Symbiosis.”
Hall: 6.1
Booth: 61D32
Website: www.symbiosis-pharma.com
Serialisation milestone
TraceLink
TraceLink reveals that more than 100 contract manufacturing organisations (CMOs) are fully configured on the TraceLink Life Sciences Cloud and ready to exchange serialisation data.
Additionally, a further 323 CMOs are currently in active testing on the company’s network and are projected to be serialisation ready in the near future. At CPhI, TraceLink, Sharp and a top 100 pharma company are sharing the key factors for implementation success, efficient on-boarding and minimising complexity ahead of serialisation deadlines.
“Contract manufacturers play a critical role in ensuring the industry is prepared for global serialisation requirements, and their readiness will help expedite the preparedness of pharmaceutical companies across the globe. Partnering with TraceLink is the fastest, most proven way for both pharmaceutical companies and CMOs to ensure successful data exchange and compliance for serialisation regulations,” says Shabbir Dahod, president and CEO of TraceLink. “As industry-wide preparations ramp up and demand increases, we’ve seen a dramatic spike in companies connecting on our network, with roughly 25 CMOs onboarding a month and an average of 50 new connections, a 400% increase from monthly onboarding projects in 2016.”
“Serialisation is a complex process that impacts all corners of the pharmaceutical industry. In order to ensure EU FMD readiness, we partner with experts that allow us to best support our customers on their serialisation journeys. With data exchange as one of the top serialization challenges, easy network connectivity to our pharmaceutical clients and the flexibility of a cloud-based central repository were key factors in our early decision to collaborate with TraceLink,” adds Staffan Widengren, director of corporate projects at Recipharm.
“As one of the industry’s early adopters of serialisation, Sharp quickly realized that connectivity would be one of the most challenging barriers to serialization. In order to streamline and standardise data exchange and connectivity for our customers, we partnered with TraceLink to leverage the value of its network and connections across the pharmaceutical supply chain. The majority of our customer base has chosen TraceLink, which immediately eliminated the complexity of making individual point-to-point connections with each of our customers,” explains Rick Seibert, senior vice president of Global Innovation & Technology Service at Sharp.
Hall: 4.1
Booth: 41B32
Website: www.tracelink.com
New bottling line
An additional bottling line is added to the Tjoapack facility in the Netherlands to meet growing demand for this service, particularly from generics customers in Europe.
The new line triples the contract packaging organisation’s (CPO’s) bottling capacity through the use of high-throughput technology. The company states it can now process 13,000 tablets per minute.
“Our decision to invest has been fuelled by greater demand for bottle packaging services from our customers, particularly in the Nordic markets. The new line will not only help us to meet this demand, but gives us access to the latest technology,” explains Dexter Tjoa, director corporate strategy at Tjoapack. “As a CPO, we see our role as being more than just packaging product. We strive to improve supply chain efficiencies and reduce time to market for all of our customers. Our new line is twice as fast as our existing line, meaning we can deliver products to our customers faster, while guaranteeing the highest quality bottle packaging service.”
The company, which specialises in primary packaging for solid dosage forms, secondary packaging and unit dose packaging, now has 19 packaging lines for blisters, wallets and bottles.
“This year we have been focused on making the necessary investments to prepare Tjoapack for growth in 2018 and beyond,” Tjoa continues. “As well as investing in new machinery to increase our capabilities and capacities in areas where we are approaching full demand, we are also making a significant investment into the latest technology. This includes revamping our entire software platforms to ensure the most robust quality and documentation management systems are in place.”
Website: http://tjoapack.com/