Fill-Finish & Packaging

Parker details investment timeline, launches new single-use system

12-Jun-2018 By Melissa Fassbender

Parker Bioscience outlines its planned investment to meet demand as the industry shifts from traditional processes to biological – for which single-use products are critical, says exec.

CMO Rentschler signs Ultragenyx fill/finish deal for US supply

01-Jun-2018 By Staff Reporter

Ultragenyx Pharmaceutical is transferring fill/finish activities for Mepsevvi from Rentschler Biopharma’s facility in Germany, to Rentschler Fill Solutions in Austria.

Fujifilm expands fill/finish services for gene therapies in Texas

29-May-2018 By Flora Southey

Fujifilm Diosynth Biotechnologies has added fill/finish capabilities for late-phase and commercial supply of gene therapies and viral vaccines.

UK invests in cell and gene therapy workforce to prepare for commercial products

29-May-2018 By Nick Taylor

The UK is investing £3m ($4m) to build a workforce capable of delivering cell and gene therapies to patients at commercial scales.

Novasep invests €10m in commercial aseptic fill/finish facility

09-May-2018 By Melissa Fassbender

Novasep is investing €10m ($11.88) in a commercial fill/finish facility for viral vectors, mAbs, and other low-volume biologics, as part of its plan to double in size by 2022.

Bio-Separation: Our outgoing editor looks back over 5 years

13-Apr-2018 By Dan Stanton

Biopharma-Reporter editor Dan Stanton is finally packing his buffer bag and moving upstream.

Bioprocessing overlap: Taking lessons from small molecule makers

03-Apr-2018 By Dan Stanton

Process control, quality management and training operators are areas where biomanufacturers can learn from small molecule makers, according to preliminary results from a BioPlan Associates survey.

Biosimilar buffer? EU thumbs up for Amgen's Neulasta delivery device

07-Mar-2018 By Dan Stanton

The EMA has recommended approval of Amgen’s on-body injector device to be used with its biosimilar-threatened Neulasta (pegfilgrastim).

Cryoport ups cold chain presence on regenerative med potential

07-Mar-2018 By Dan Stanton

Cryoport will open two global centres and has inked a deal with McKesson to support the growth in demand for cell and gene therapy logistics.

MSD repurposing dormant Irish site and hiring 350 to support Keytruda

14-Feb-2018 By Dan Stanton

Merck Sharp & Dohme (MSD) plans to build a biologics facility at a former small molecule manufacturing site in Swords, Ireland, which it closed last year.

Celltrion FDA warning causes headache for Teva’s biologics ambition

13-Feb-2018 By Dan Stanton

A warning letter at manufacturing partner Celltrion could delay approvals of the potential migraine prevention monoclonal antibody fremanezumab and two biosimilar candidates, says Teva.

UK collaboration to manufacture commercial viral vectors

09-Feb-2018 By Dan Stanton

Cobra Biologics and Symbiosis have received a grant to establish a commercial viral vector manufacturing facility in the UK.

Cook in the books: Biologics acquisition boosts Catalent Q2

09-Feb-2018 By Dan Stanton

Catalent has partially attributed a 26% year-on-year growth in its Drug Delivery Solutions segment to the acquisition of Cook Pharmica, which closed in the quarter.

Cryoport wins TiGenix logistics contract and braces for CAR T roll out

09-Feb-2018 By Staff Reporter

Cryoport will provide cold chain logistics to TiGenix as it conducts phase Ib/IIa allogeneic adipose‐derived stem cells for the treatment of sepsis.

Vetter securing customer commitments ahead of groundbreaking at US site

06-Feb-2018 By Melissa Fassbender

Vetter is talking with customers to create a “stable financial plan” that will justify the manufacturer’s previously announced $320m investment for a new facility, which is not expected to break ground before 2022.

Adaptimmune begins in-house T-cell therapy manufacture at PA plant

06-Feb-2018 By Staff Reporter

Adaptimmune Therapeutics has manufactured the first SPEAR-T cells for a patient at its Navy Yard facility, which will be the primary site for its future manufacturing requirements.

Celltrion slammed with US FDA warning at biosimilar site

02-Feb-2018 By Dan Stanton

Celltrion says supply of Pfizer’s Inflectra is secure, despite receiving a US FDA warning letter at its biosimilar production plant in Korea.

Cellular Biomedicine Group adopts GE Healthcare tech for CAR-T therapy production

19-Jan-2018 By Gareth Macdonald

Cellular Biomedicine Group Inc (CBMG) has selected GE Healthcare’s FlexFactory technology for its CAR-T therapy production facility in Shanghai, China.

Meissner expands aseptic fill/finish range through PDC acquisition

18-Jan-2018 By Staff Reporter

Meissner Filtration Products has bolstered its automated filling offerings through the acquisition of PDC Aseptic Filling Systems.

Aviragen Vaxart merger to create $264m tablet vaccine firm

15-Jan-2018 By Dan Stanton

Aviragen Therapeutics has called on shareholders to back its proposed merger with oral vaccine delivery firm Vaxart.

ADCs: Global service demand buoyed by approvals, WuXi

20-Dec-2017 By Dan Stanton

Antibody-drug conjugates (ADCs) are one of the “hottest areas of research” says STA Pharmaceutical and WuXi Biologics which are investing in conjugation and fill/finish capabilities in China.

Big batches, big margins: Reneuron on off-the-shelf stem cells

15-Dec-2017 By Dan Stanton

Difficulty in scaling-up autologous cell therapies means margins are low says Reneuron, which is focused on off-the-shelf stem cell products.

Lilly to pump $1.2bn into its biomanufacturing in 2018

15-Dec-2017 By Dan Stanton

Eli Lilly has projected an increased spend across its biomanufacturing network next year to support bulk production and fill/finish of monoclonal antibodies.

Microbial systems, fill/finish or vaccines? Avid eyeing up bolt-on services

13-Dec-2017 By Dan Stanton

Avid Bioservices says it is looking to expand its biomanufacturing offering as it transitions into a pure-play CDMO from Peregrine Pharmaceuticals.

Cell Therapy Manufacturing & Gene Therapy Congress

Kite talks audits, training and dry runs across CAR T supply chain

12-Dec-2017 By Dan Stanton

CAR T developers must be involved throughout the entire supply chain says Kite Pharma, which depends on accreditation and training programmes across its network of Yescarta administration clinics.

Biocad bringing biosimilars to North Africa through fill/finish plant

08-Dec-2017 By Flora Southey

Biocad has partnered with Sothema to make biosimilars in North Africa, which it says will boost access to biologics for ‘less affluent’ patients.

Mylan: Reinspection of Biocon plant brings biosimilar confidence

01-Dec-2017 By Dan Stanton

The EMA has accepted to review Mylan’s trastuzumab and pegfilgrastim biosimilars amid remediation efforts at biomanufacturing partner Biocon’s fill and finish plant in India.

Vetter enters biologics ‘sweet spot’ through Korean office

10-Nov-2017 By Dan Stanton

Fill and finish CDMO Vetter says its newly opened sales office in Songdo will tap the large Korean biologics market.

UPDATE

Needle-free biologics: Takeda & Portal develop delivery tech for Crohn’s

09-Nov-2017 By Flora Southey

Takeda has partnered with Portal Instruments to develop a needle-free drug delivery device for biologic medicines, starting with the former’s Entyvio (vedolizumab).

Catalent: Cook deal strengthens sub 5,000L scale CMO strategy

08-Nov-2017 By Dan Stanton

70% of the biologics pipeline will require less than 5,000L of commercial manufacturing capacity says Catalent, fresh from its acquisition of Cook.

Gilead ramping up CAR T clinics after US FDA Yescarta approval

20-Oct-2017 By Dan Stanton

Gilead says it is looking to make as many as 90 academic centres available to administer CAR-T Yescarta (axicabtagene ciloleucel) following its approval in the US.

'Luxturna' recommendation good for all AAV based gene therapies says advocacy group

18-Oct-2017 By Gareth Macdonald

The US approval recommendation for Spark Therapeutics’ blindness gene therapy voretigene neparvovec is also an endorsement of AAV delivery technologies according to the Alliance for Regenerative Medicine.

CMC data issues at Biocon plant prompt US FDA to reject Neulasta biosimilar

11-Oct-2017 By Dan Stanton

Mylan and Biocon have received a complete response letter for a version of Amgen’s Neulasta (pegfilgrastim) in the latest regulatory blow to their biosimilar ambition.

IPS & G-CON launch prefabricated cleanrooms biz

06-Oct-2017 By Flora Southey

Integrated Project Services (IPS) and G-CON Manufacturing are collaborating to supply prefabricated cleanrooms for biomanufacturing, known as PODs.

Biotech Week Boston

On the roadmap again: Industry to address 'never ending' bioprocessing evolution

27-Sep-2017 By Dan Stanton

The Biophorum Operations Group (BPOG) has begun working on 11 technology development projects after publishing its first roadmap, but the bioprocessing industry’s visions are forever evolving, says Sanofi-Genzyme.

Filling and freeze-drying drivers for $950m Cook deal says Catalent

22-Sep-2017 By Gareth Macdonald

Catalent has cited Cook’s ability to make and freeze-dry liquid drugs as major drivers for its planned takeover and said it is keen to take on the firm’s biopharma customers.

Robust logistics system key challenge for cell therapies, Kiadis

22-Sep-2017 By Dan Stanton

Kiadis Pharma says it is looking at expanding production of its blood cancer cell therapy candidate ATIR101 after receiving US FDA breakthrough designation.

Kaneka Eurogentec to build biodrug production plant in Belgium

14-Sep-2017 By Gareth Macdonald

Kaneka Eurogentec has announced plans to build a biopharmaceutical manufacturing facility in Seraing, Belgium.

Expression yourself: Win an iPad in our bioprocessing survey

12-Sep-2017 By Dan Stanton

Is plastic fantastic? Is stainless still à la mode*? Do Chinese hamsters continue to tow the cell line? Biopharma-Reporter wants your opinions for its second annual biomanufacturing survey.

Celltrion confident in quality of biosimilar supply despite US FDA 483

07-Sep-2017 By Dan Stanton

Celltrion Inc has received a FDA Form 483 with 12 observations but remains confident no exported biosimilar products have any quality issues.

GE launches cell therapy thawing tech

06-Sep-2017 By Dan Stanton

GE Healthcare has launched a thawing technology for cell therapies it says removes the risks and inconsistencies of standard water baths.

Roche to up Russian Gazyva supply through local fill/finish deal

06-Sep-2017 By Dan Stanton

Local manufacturer Pharmstandard will make the finished dosage form of Roche’s monoclonal antibody Gazyva (obinutuzumab) at its site in Ufa.

Dude where’s my CAR-T? Personalised meds need personalised logistics, says TrakCel

01-Sep-2017 By Dan Stanton

After receiving approval Kymriah, Novartis must prove it can handle the supply chain complexities of manufacturing high-value and time-sensitive CAR-T cell therapies, says logistics firm TrakCel.

US FDA clarifies what constitutes 'minor' change to biologic production process

09-Aug-2017 By Gareth Macdonald

The US FDA has sought to clarify when biologics firms should inform it about minor changes to manufacturing processes in draft guidance this week.

update

Hep B vaccine supply issues at Merck & Co and GSK prompt UK to prioritize access

08-Aug-2017 By Gareth Macdonald

Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK.

Celltrion Healthcare $890m IPO to up biosimilar inventory and broaden portfolio

04-Aug-2017 By Dan Stanton

Celltrion Healthcare will purchase more biosimilars from biomanufacturing partner Celltrion Inc. and expand its distribution network after raising one trillion Won ($888m) in an IPO.

Sanofi signs nanobody drug and tech deal that could earn Ablynx billions

21-Jul-2017 By Gareth Macdonald

Sanofi has licensed access to Ablynx NV’s nanobody platform as well as candidate drugs in a deal that could earn the Belgian firm billions of euros.

Sanofi shells out $650m for non-egg based vaccine maker Protein Sciences

11-Jul-2017 By Dan Stanton

Sanofi will add the recombinant protein-based influenza vaccine Flublok to its products, along with a manufacturing facility in Pearl River, New York.

Shire focusing on biotechnology and R&D hubs in MA operations shake up

11-Jul-2017 By Dan Stanton

Shire will consolidate both R&D and biomanufacturing facilities in Massachusetts to establish a rare diseases hub in Cambridge and a ‘Technology Center of Excellence’ in Lexington.

Mylan's EU biosimilar ambition hit by GMP issues at Biocon plant

10-Jul-2017 By Dan Stanton

Three biosimilar products submitted to the EU for approval have suffered a setback after regulators found 35 GMP deficiencies at Biocon’s fill/finish facility in Bangalore, India.