The pharmaceutical market is undergoing a profound transformation, driven by innovation among biologics and advanced therapies (ATs). This shift is not only redefining the treatment landscape but also presenting new opportunities and challenges related to the drug development and manufacturing value chain.
Contract development and manufacturing organizations (CDMOs) are a crucial part of the life sciences industry. Strangely, despite its current prominence, the CDMO industry is a relatively young one. There have been significant developments over its short lifespan, and it is likely that we see even more growth in the years to come.
CDMO CordenPharma, a specialist in active pharmaceutical ingredients (APIs), excipients, drug products and packaging services, inaugurated an increased commercial peptide production capacity with newly-upgraded facilities at its Colorado site in the US, which the company says is the world's largest solid-phase peptide synthesis (SPPS) manufacturing facility.
Last week, Lonza and Vertex Pharmaceuticals broke ground on a new US facility in Portsmouth, New Hampshire, to manufacture cell therapies for diabetes.
Active pharmaceutical ingredients manufacturer EuroAPI has agreed to acquire BianoGMP, a contract development and manufacturing organization (CDMO) specializing in oligonucleotides. Biano is to become a EuroAPI company but retain its corporate brand.
Finnish contract development and manufacturing organization (CDMO) Biovian, specializing in biopharmaceuticals, is investing more than €50 million to expand its manufacturing facility in Turku, Finland.
Upperton Pharma Solutions, a UK contract development and manufacturing organization (CDMO), has completed construction of its new development and GMP manufacturing headquarters in Nottingham, UK. The company said it has invested £15 million in the new 50,000-square-foot facility.
For Siegfried, sustainability is much more than a phrase with a green coating. The term, which encompasses social and economic criteria in addition to ecological aspects, is one of five central corporate values. One of the biggest levers for reducing energy and resource consumption in the pharma supply chain lies in the efficient production of active ingredients and pharmaceuticals. The company therefore works consistently on optimizing its processes.
After acquiring the two Catalonian sites in Barberà del Vallès and El Masnou about two years ago, Siegfried is now significantly expanding its expertise in the production of complex Drug Products containing Highly-Potent APIs (HPAPIs). In addition, the company has opened a new development center for oral solid dosage forms with active ingredients and HPAPIs as well as for ophthalmic sterile products. This not only strengthens Siegfried's position in the area of drug products, but also its global network and international competitiveness.
The market for APIs is expanding significantly. Experts predict annual growth rates between 4.5 and 7.6 percent by 2029. There are plenty of good reasons for this: Chronic diseases are on the rise - and with them the need for medicines and active ingredients. In addition, the economic upswing in several emerging countries means that more people can afford novel medicines. APIs are also benefiting from the trend toward personalized medicine and the growing understanding of diseases. Meanwhile, API developers and manufacturers are working on increasingly sophisticated methods to better handle these delicate substances.
The Pharmaceutical industry must prioritize sustainability. Jürgen Roos, Chief Scientific Officer (CSO) of Siegfried, explains opportunities and limits of sustainability.
There are only a few chemical and pharmaceutical companies that look back at a history of 150 years. Certainly, many companies claim such a long legacy, but if you only count those that have been operating and thriving under the same name for a century and a half, the number boils down significantly.
Climate change, energy crisis, the call for a more environmentally compatible production method and socially responsible action do not stop at the pharmaceutical and biotech industries. Sustainability is becoming a central competitive and reputation factor and carries a high economic value. This need not be to the industry´s disadvantage. It helps companies to make processes more efficient, reduces energy consumption and keeps costs in check. But is the pharmaceutical industry already doing enough in this regard?
The Fill & Finish of biologic drugs is expensive and poses special technological challenges for CDMOs. At the German site in Hameln, Siegfried has successfully proven these capabilities over the past two years by producing Covid-19 vaccines and a significant number of clinical batches for several biological companies. By investing in its competencies, capacities and flexibility, the company intends to further expand this demanding but promising business area.
The CDMO (contract development and manufacturing organizations) business has a bright future, of that Siegfried CEO Wolfgang Wienand is certain. The economic advantages alone speak for this compared to in-house production by the pharmaceutical companies themselves. Although Siegfried has already reached sufficient critical size within its industry, he sees the company continuing on its growth path. The goal is to take over an even larger share of the value chain from pharmaceutical companies in the future.
Olon, an Italian CDMO and API producer, is investing a total of €100 million in 2023 to increase production capacity, in particular at its site in Mulazzano, Lodi province.
Swiss CDMO Siegfried has acquired a 95% stake in Dinamiqs, a compatriot biotech focused on developing and manufacturing viral vectors for cell and gene therapies.
CordenPharma is expanding strategically into synthetic oligonucleotide manufacturing at its plant at Boulder in the US state of Colorado. The two-phase investment is designed to provide innovative biotech and pharma customers with a fully integrated API to Drug Product service offering.
WuXi STA has added two reactors at its Changzhou campus in China, enhancing capacity and capability at its TIDES contract research, development and manufacturing platform for oligonucleotide, peptide and related synthetic conjugates. The reactors have capacity of 2,000 liters each, taking total volume for solid-phase peptide synthesizers to more than 10,000 liters.
Catalent, a US-headquartered CDMO, has broken ground on a project in Schorndorf, Germany, that will add capacity for storing and handling clinical trial supply materials at controlled temperatures.
In this interview, Jinling Chen, head of WuXi STA’s drug product business, and Jamie Andrews, site head of WuXi STA’s Couvet facility, explain the company’s strategy and the goals of the European expansion.
Hanno Scheffczik has been appointed as the new Managing Director of Temmler Pharma, a member of the Aenova Group. Effective Mar. 1, 2023, he succeeds Alfred Veit, who is retiring.
Interview with Sylke Hassel, previous CEO of PharmaZell and current CEO of Axplora following the merger with Novasep.
Canadian CDMO Biodextris plans to build a new industrial-scale vaccine and biologics facility in Laval, Quebec. The company said the cGMP biomanufacturing center and its analytical capabilities will be an asset in its development as a world-class CDMO.
Lotte Biologics, part of South Korean conglomerate Lotte, has detailed expansions plans for the business as it embarks on a path to become a top 10 CDMO by 2030.
Catalent has opened a new commercial-scale cell therapy manufacturing facility at its European center of excellence for cell therapies in Gosselies, Belgium.
Executives and industry experts share their views on drivers as well as barriers for the use of flow chemistry in pharmaceutical manufacturing and the prospect for this technology in their industry sector.
US-headquartered CDMO giant Catalent has completed the expansion of its clinical supply facility in the Waigaoqiao Free Trade Zone (FTZ) in Shanghai, China.
UK specialist healthcare investor GHO Capital Partners and US investment firm The Vistria Group have entered into an agreement to buy a controlling interest in US CDMO Alcami from current private equity owners Madison Dearborn Partners (MDP) and Ampersand Capital Partners. Financial terms of the deal were not disclosed.
US CDMO Curia has begun construction on an expansion of its campus in Albuquerque, New Mexico. The facility designed by Burns & McDonnell will be built by BE&K Building Group.
Swedish multinational CDMO Recipharm has bolstered its sterile filling capabilities at its facility in Kaysersberg, France, by installing Lab+ continuous automated technology.
Dutch CDMO Symeres has acquired Exemplify Biopharma, a US-based contract research organization (CRO) based in Cranbury, New Jersey, USA. The deal further strengthens Symeres’ foothold in the US, where it already generates about 50% of its revenues.
Catalent has announced a $12 million expansion program to increase biologics CGMP analytical capabilities at its flagship facility in Kansas City, Missouri.
The increasing complexity in drug development and the highly competitive industry landscape are creating a dramatic shift in how pharmaceutical and biotech companies plan for and execute drug development and production.
Interview with Marc Doyle, CEO of Arxada, which was created following the carve-out and sale of Lonza Specialty Ingredients to private equity firms Bain Capital and Cinven.
