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How HEMLIBRA® Is Made

The manufacturing process for HEMLIBRA is as rigorous as the scientific research. Learn more about the collaborative process of discovering, developing, and manufacturing HEMLIBRA below.

Discovering HEMLIBRA

How HEMLIBRA was discovered: Researchers discovered one therapeutic antibody as a match among 40,000 tested when studying possible treatments for hemophilia A.

Researchers studying treatments for hemophilia A had an idea to use an antibody to play a possible role in the clotting process. Antibodies are a natural part of the immune system that protect the body from harm. 3 Researchers hypothesized that a specifically designed antibody, called a therapeutic antibody, may be able to connect key proteins in the coagulation cascade to perform the function of the missing factor VIII. 4

Because an antibody is not the same as factor VIII, researchers theorized that this antibody could be used in people with inhibitors to factor VIII.

After almost 10 years and trying 40,000 different therapeutic antibodies to find a match, HEMLIBRA was discovered as a possible antibody for clinical trials.

Developing HEMLIBRA 

How HEMLIBRA is developed: The therapeutic antibody is humanized, modified, and purified.

  • Scientists then modified the therapeutic antibody with the goal of making it more similar to ones that are normally produced in humans (humanized) 4 
  • The researchers also modified the therapeutic antibody to affect its movement through the body and ability to stay in the body (pharmacokinetics) 4 
  • Lastly, the antibody went through a purification process to remove unwanted substances 4

Manufacturing a therapeutic antibody

HEMLIBRA is a therapeutic antibody manufactured with biotechnology using the Chinese hamster ovary (CHO) cell line. 5

Like the discovery and development stages, manufacturing a therapeutic antibody is also a rigorous scientific process. It’s an exacting process that involves hard work from thousands of dedicated people.

When therapeutic antibodies like HEMLIBRA are made in a laboratory using biotechnology, 5 there are multiple, controlled purification steps taken to produce and purify, or clean, the therapeutic antibody and remove unwanted substances.

Manufacturing process 

How HEMLIBRA is made: 1. Genetic material is inserted into CHO cells 2. Cells grow and multiply to produce the target antibody 3. The antibody is separated from the cells and purified 4. The sterile medicine is tested for potency and purity

HEMLIBRA doesn’t contain human plasma or human blood components. 5
HEMLIBRA does not come from human blood. Human plasma and human blood components are not used in the manufacturing of HEMLIBRA. 
 
 

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Important Safety Information & Indication

Indication

HEMLIBRA® is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors.

Important Safety Information
Boxed WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM
Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.

Warnings and Precautions
Thrombotic Microangiopathy (TMA) and Thromboembolism Associated with HEMLIBRA and aPCC
In clinical trials, TMA was reported in 0.8% of patients (3/391) and thrombotic events were reported in 0.5% of patients (2/391). In patients who received at least one dose of aPCC, TMA was reported in 8.1% of patients (3/37) and thrombotic events were reported in 5.4% of patients (2/37). Patients with TMA presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13.

Consider the benefits and risks if aPCC must be used in a patient receiving HEMLIBRA prophylaxis. Monitor for the development of TMA and/or thromboembolism when administering aPCC. Immediately discontinue aPCC and interrupt HEMLIBRA prophylaxis if clinical symptoms, imaging, or laboratory findings consistent with TMA and/or thromboembolism occur, and manage as clinically indicated. Consider the benefits and risks of resuming HEMLIBRA prophylaxis following complete resolution of TMA and/or thrombotic events on a case-by-case basis.

Laboratory Coagulation Test Interference
HEMLIBRA affects intrinsic pathway clotting-based laboratory tests, including activated clotting time (ACT); activated partial thromboplastin time (aPTT); and all assays based on aPTT, such as one-stage, factor VIII (FVIII) activity. Therefore, intrinsic pathway clotting-based coagulation laboratory test results in patients who have been treated with HEMLIBRA prophylaxis should not be used to monitor HEMLIBRA activity, determine dosing for factor replacement or anti-coagulation, or measure FVIII inhibitor titers.

Results affected by HEMLIBRA: aPTT; Bethesda assays (clotting-based) for FVIII inhibitor titers; one-stage, aPTT-based single-factor assays; aPTT-based Activated Protein C Resistance (APC-R); ACT.

Results unaffected by HEMLIBRA: Bethesda assays (bovine chromogenic) for FVIII inhibitor titers; thrombin time (TT); one-stage, prothrombin time (PT)-based single-factor assays; chromogenic-based single-factor assays other than FVIII (see Drug Interactions for FVIII chromogenic activity assay considerations); immuno-based assays (ie, ELISA, turbidimetric methods); genetic tests of coagulation Factors (eg, Factor V Leiden, Prothrombin 20210).

Most Common Adverse Reactions
The most common adverse reactions (incidence ≥10%) are injection site reactions, headache, and arthralgia.

Adverse Reactions
Characterization of aPCC Treatment in Pooled Clinical Trials
There were 130 instances of aPCC treatment in 37 patients, of which 13 instances (10%) consisted of on average a cumulative amount of >100 U/kg/24 hours of aPCC for 24 hours or more; 2 of the 13 were associated with thrombotic events and 3 of the 13 were associated with TMA. No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.

Injection Site Reactions
In total, 85 patients (22%) reported injection site reactions (ISRs). All ISRs observed in HEMLIBRA clinical trials were reported as mild to moderate intensity and 93% resolved without treatment. The commonly reported ISR symptoms were injection site erythema (11%), injection site pruritus (4%), and injection site pain (4%).

Other Less Common (<1%) Reactions
Rhabdomyolysis was reported in 2 adult patients with asymptomatic elevations serum creatine kinase without associated renal or musculoskeletal symptoms. In both instances, the event occurred following an increase in physical activity.

Drug Interactions
Clinical experience suggests that a drug interaction exists with HEMLIBRA and aPCC.

Pregnancy, Lactation, Females and Males of Reproductive Potential
Women of childbearing potential should use contraception while receiving HEMLIBRA. It is not known whether HEMLIBRA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HEMLIBRA should be used during pregnancy only if the potential benefit for the mother outweighs the risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HEMLIBRA and any potential adverse effects on the breastfed child from HEMLIBRA or from the underlying maternal condition.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the HEMLIBRA full Prescribing Information for additional Important Safety Information, including Boxed WARNING. 

References

3.

Genentech. Therapeutic antibodies: the next generation. https://www.gene.com/stories/therapeutic-antibodies-the-next-generation. Accessed November 23, 2017.

 

 

 

4.

Sampei Z, Igawa T, Soeda T, et al. Identification and multidimensional optimization of an asymmetric bispecific IgG antibody mimicking the function of factor VIII cofactor activity. PLoS One. 2013;8(2):e57479.

 

 

 

5.

Jayapal KP, Wlaschin KF, Hu WS, et al. Recombinant protein therapeutics from CHO cells—20 years and counting. Chem Eng Prog. 2007;10(suppl):40-47.

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