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Global biologics demand driving MabPlex expansions

MabPlex has opened a facility in Yantai, China with up to 24,000 L of single-use capacity to serve the growth in biomanufacturing demand. MabPlex International, a contract development and manufacturing organization (CDMO) focused on monoclonal antibodies and antibody-drug conjugates (ADCs), has expanded its global offering through the opening of a commercial plant in Yantai, China. The ribbon cutting ceremony took place in September and according to the firm, the expansion helps feed the global demand in biologics services. “The demand…

Teva two: FDA approves Celltrion-made Herceptin biosimilar

by BPI Staff

The US FDA has approved a second biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab): Celltrion’s Herzuma, to be marketed by Teva. In 2016, Israeli firm Teva Pharmaceutical Industries expanded its biosimilar portfolio by teaming up with Korean drugmaker Celltrion. The $160 million (€141 million) deal gave Teva the US rights to versions of Roche’s Rituxan (rituximab) and Herceptin. The former received US Food and Drug Administration (FDA) approval last month, and now the latter has been given the regulatory…

Korea exchange: Celltrion probed as Samsung Bio resumes trading

by Dan Stanton

An investigating has begun into alleged accounting irregularities between Celltrion Inc. and its affiliate Celltrion Healthcare. Meanwhile, Samsung BioLogics has recommenced share trading a month after being hit by its own accountancy problems. South Korea’s Financial Supervisory Services (FSS) is looking into the business dealings of drugmaker Celltrion Inc and its wholesaler and marketing affiliate Celltrion Healthcare, according to Korean news outlet YTN. The article claimed Celltrion Healthcare violated accounting rules by selling the domestic distribution rights of biological medicines…

Manufacturing shutdowns and idle capacity mar Avid’s Q2

by Dan Stanton

Business is up and proposal requests are increasing, but planned sequential maintenance shutdowns of both Avid’s manufacturing facilities hit the CDMO’s second quarter revenues. For the second quarter FY19, Avid Bioservices reported manufacturing revenue of $10.2 million (€9 million), down 20% on the same period last year. The firm – which became a pureplay contract development and manufacturing organization (CDMO) in January 2018 – attributed the drop to planned sequential maintenance shutdowns of both its Californian production plants. The Franklin…

Lonza to biomanufacture in China with a little help from GE

by Dan Stanton

Changing policies in China bring opportunities for foreign CDMOs says Lonza, which is opening a biologics facility in Guangzhou, supported by GE Healthcare. Swiss contract development and manufacturing organization(CDMO) Lonza has announced it is constructing its first biomanufacturing facility in China. The 17,000 m² plant will be based on GE Healthcare’s off-the-shelf modular biologics factory, KUBio platform, and will supply antibody drugs to the local market. “We do have an established presence in China and in theGuangzhou district but this…

French staff cuts but Sanofi committed to $800m biomanufacturing plans

by Dan Stanton

Sanofi will cut 750 jobs in France but says it remains committed to biologic and vaccine manufacturing investments totaling €700 million ($800 million) in the country. With civil unrest breaking out on the streets of Paris as members of the so-called ‘Gilets Jaunes’ demand everything from lower taxes to better job security, France’s largest biopharma firm Sanofi has revealed plans to reduce its domestic workforce by 750, and scrap plans to recruit a further 250 staff. “Sanofi in France informed…

J&J and Merck team with UK gov on $97m vaccine manufacturing center

by Dan Stanton

The UK government-led Vaccines Manufacturing Innovation Centre will have pilot and medium-scale capacity and the ability to respond to threats of serious infections. The center, to be built in Oxford, UK will focus on the production of vaccines for outbreaks of diseases such as Ebola and Lassa fever, bridging the gap between academia and industry. The project has been funded by the UK government’ Industrial Strategy, a business-backing program from the Department for Business, Energy & Industrial Strategy aimed at…

Amgen on Soliris: Low patient population but high biosimilar potential

by Dan Stanton

The high cost of Alexion’s ultra-orphan disease MAb Soliris (eculizumab) drove Amgen’s decision to develop a biosimilar version, says SVP of Global Development Elliott Levy. Soliris (eculizumab) is an approved treatment for orphan diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (a-HUS) treatment. The monoclonal antibody (MAb) was – until the arrivals of CAR-T and gene therapies Kymriah, Yescarta and Luxturna last year – the most expensive drug in the world, and netted Alexion $3.1 billion (€2.8 billion)…

Teva settles with Roche to launch first Rituxan biosimilar in US

by Dan Stanton

Truxima becomes the 15th biosimilar, and the first version of Rituxan (rituximab), to be approved in the US. A settlement agreement with Roche will allow Teva to market the product but the launch date has not been revealed. The US Food and Drug Administration (FDA) gave the thumbs up to Truxima this week, making it the first biosimilar version of Roche/Genentech’s Rituxan to be approved in the US. The product is manufactured by South Korean firm Celltrion but will be…

Aji Bio enters ‘rapidly growing’ ADC space

by Dan Stanton

Ajinomoto Bio-Pharma Services has launched a bioconjugation technology it says has high productivity and short conjugation reaction times. According to contract development and manufacturing organization (CDMO) Aji Bio-Pharma, its AJICAP technology lets antibody-drug conjugates (ADC) developers better control the location of payload conjugation to an antibody and fine tune the quantity of payload attached. “The technology deploys a proprietary affinity peptide to direct controlled conjugation to a specific sites on the antibody in a relatively straight forward synthetic process,” Jason…